Sep 11, 2025
Table of Contents
On September 8, 2025, ONWARD Medical N.V., a leading neurotechnology company developing therapies to restore movement, function, and independence for individuals with spinal cord injuries (SCI) and other mobility impairments, announced that it has received CE Mark certification for its ARC-EX System under the European Union Medical Device Regulation (MDR). This milestone enables the company to commercialize the ARC-EX System across the European Union and in select other countries.
The certification permits ONWARD Medical to market the ARC-EX System for use alongside functional task practice to enhance hand strength and sensation in adults living with a chronic, non-progressive neurological deficit caused by an incomplete spinal cord injury (C2–C8). Approved for both clinical and home use, the ARC-EX System is a non-invasive device that delivers programmed, transcutaneous electrical spinal cord stimulation through electrodes applied to the back of the neck.
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“Hand sensation and strength is a primary recovery target after spinal cord injury. The ARC-EX Therapy opens new doors for the SCI community in Europe, offering opportunities for recovery and care that were previously unavailable,” said Dave Marver, Chief Executive Officer of ONWARD Medical. “The CE Mark certification for ARC-EX was awarded far earlier than expected and it gives us great satisfaction to bring this important new therapeutic option to the European spinal cord injury community. We will initiate a phased launch in Europe in the coming weeks, starting with Germany, and cascading to other countries as soon as possible thereafter.”
The ARC-EX System is backed by a robust body of clinical evidence. Findings from the Up-LIFT pivotal study, published in Nature Medicine, revealed that 90% of participants experienced improved strength or function, while 87% reported a better quality of life, with benefits observed even up to 34 years post-injury. Additional outcomes included reduced spasm frequency, enhanced sleep quality, and improved upper body sensation and tactile perception.
Further support came from the investigator-sponsored Pathfinder2 Study, published in Neuromodulation: Technology at the Neural Interface, which demonstrated that ARC-EX Therapy, when combined with activity-based rehabilitation, delivered substantial functional gains. After one year of treatment, participants continued to show improvements in upper body strength, trunk control, and balance, with no plateau in therapeutic benefit.
As part of the CE Mark application process, ONWARD Medical secured its first certification under the European Medical Device Regulation (MDR), successfully meeting stringent European standards for patient safety, clinical performance, risk management, and post-market surveillance.
In early 2025, the company began the phased U.S. launch of the ARC-EX System following FDA clearance. ONWARD has since met its commercial objectives for the first half of 2025, driven by strong demand and highly positive feedback from initial users. The ARC-EX System has also earned global recognition, being named one of TIME Magazine’s Best Inventions of 2024 and selected as one of Fast Company’s World Changing Ideas 2025 for its transformative potential in patient care.
As per DelveInsight’s “Spinal Cord Stimulators Market Report,” the spinal cord stimulators market was valued at USD 3,437.62 million in 2024, growing at a CAGR of 9.83% during the forecast period from 2025 to 2032 to reach USD 7,243.98 million by 2032. The spinal cord stimulator market is experiencing significant growth due to the increasing number of patients suffering from chronic pain and neuropathic pain, particularly in areas such as the shoulders, legs, and knees. Moreover, the degenerative spine conditions, such as chronic pain associated with diabetic neuropathy, spinal cord injury, and failed back surgery syndrome, among others, are other contributing factors for market growth. Additionally, favorable government regulations have played a crucial role in accelerating the commercialization and launch of advanced spinal cord stimulation devices. The rising geriatric population, which is more susceptible to chronic and neuropathic conditions, is also contributing to market expansion. These factors, collectively, are expected to propel the growth of the spinal cord stimulator market throughout the forecast period from 2025 to 2032.
On September 8, 2025, Microbot Medical Inc., the developer and manufacturer of the groundbreaking LIBERTY® Endovascular Robotic System, announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for the LIBERTY® System. This milestone makes LIBERTY® the first FDA-cleared, single-use, remotely operated robotic system designed for peripheral endovascular procedures. The clearance paves the way for the Company to commercialize LIBERTY® in the United States, aiming to revolutionize the field by expanding access to advanced robotics without the limitations of traditional capital equipment or specialized infrastructure.
“Obtaining FDA 510(k) clearance for LIBERTY® marks a defining moment for Microbot Medical and, we believe, for the future of endovascular robotics. This achievement validates our mission to expand access to advanced robotic technologies while addressing critical unmet needs and supporting cost-effective healthcare,” commented Harel Gadot, Chairman, CEO & President. “With our commercial readiness strategy being developed and executed since Q2 this year, we believe we are well positioned to accelerate market entry. With FDA clearance, we can now complete the final commercial activities that were contingent on marketing clearance, positioning us to commence commercialization, penetrate the approximately 2.5 million annual U.S. peripheral vascular procedures, and pursue entry into global markets.”
The LIBERTY® pivotal study demonstrated 100% success in robotic navigation to the target with no device-related adverse events. Results further highlighted a 92% relative reduction in physician radiation exposure. Designed for remote operation, the system is expected to enhance ergonomics and help reduce physical strain on healthcare providers. The Company believes LIBERTY® can drive greater procedural efficiency, lower overall costs, and elevate the quality of care. As part of its commercial launch, the Company intends to continue gathering clinical data to further validate LIBERTY®’s benefits.
As per DelveInsight’s “Surgical Robotic System Market Report”, the surgical robotic systems market was valued at USD 11,082.32 million in 2024, growing at a CAGR of 13.21% during the forecast period from 2025 to 2032 to reach USD 29,785.13 million by 2032. The rising incidence of chronic disorders such as cancer, cardiovascular diseases, and orthopedic conditions is significantly boosting the demand for advanced surgical interventions, thereby propelling the growth of the surgical robotic systems market. As chronic conditions often require complex, high-precision surgeries, robotic-assisted procedures, including minimally invasive surgery devices and interventional cardiology/vascular devices, offer enhanced accuracy, minimal invasiveness, and quicker recovery times, making them highly suitable for treating such ailments. Simultaneously, the increasing number of surgical procedures globally, driven by a growing aging population and a higher prevalence of lifestyle-related health issues, is further escalating the need for efficient and precise surgical tools. In response, key market players are heavily investing in product development activities, focusing on innovations such as compact robotic platforms, AI integration, and advanced visualization systems. These advancements not only expand the scope of robotic surgery across multiple specialties but also improve surgical outcomes, thereby contributing to the growth of the surgical robotic systems market during the forecast period from 2025 to 2032.
On September 9, 2025, Fraiya, a UK-based femtech startup, made significant progress in transforming pregnancy ultrasound with AI. The company achieved several key milestones, including NHS clinical evaluation, regulatory approval, and closing a pre-seed funding round, marking its rise as a strong player in maternal health innovation.
Fraiya’s main product, FraiyaScan, helped clinicians during the 20-week anomaly scan by automating real-time image acquisition, quality checks, measurements, and clinical reporting. Designed in collaboration with the NHS, sonographers, and fetal medicine specialists, the tool integrated smoothly into existing scanning workflows without disrupting routine practice.
Working with King’s College London, Fraiya launched a prospective multi-centre randomised controlled trial of FraiyaScan, along with an AI-assisted second review service, involving over 9,500 pregnant women across four NHS hospitals. This was one of the first large trials evaluating both clinical performance and health economic impact of an AI imaging tool. Funded by the UK’s National Institute for Health and Care Research, the trial measured cost-effectiveness, workflow efficiency, and effects on staff and patient experience.
FraiyaScan received CE-mark Class IIa certification under the EU Medical Device Regulation, approved by Scarlet NB. The regulatory submission was led by Fraiya’s CTO, Dr. Sam Budd, with support from the Medical Engineering Quality and Regulatory Team at King’s, ensuring clinical safety and scalability. This approval allowed commercial use of FraiyaScan in hospitals and clinics across the UK and EU.
The company closed its pre-seed round, raising £3.5 million from grants, awards, VC, and angel investors, including RAW Ventures and Cedars-Sinai Ventures. The funding supported clinical deployment in the UK and EU, further regulatory submissions, and expansion into adjacent product lines.
Fraiya originated from the iFIND project at King’s College London and Imperial College, supported by a £10 million EPSRC and Wellcome Trust innovation grant. The founding team combined expertise in AI, imaging, digital health, and maternal-fetal care. Fraiya also participated in two medtech venture accelerators: the London Institute for Healthcare Engineering and the Cedars-Sinai Accelerator in Los Angeles, focusing on building AI that fits seamlessly into clinical workflows.
Professor Razavi, Friaya’s CEO and chief investigator of the trial, said: “We see this trial as a turning point. It’s not just about proving our AI tools work, it’s about proving they add value to the health system.“As a clinician who looks after babies with congenital problems, I see the difference between those who are diagnosed in pregnancy and get planned care with parents who are fully informed and prepared for what’s to come, and those who unfortunately were not picked up during the pregnancy scans, who arrive at our hospital very unwell and without a diagnosis, with very anxious parents, and have a more difficult journey. Fraiya’s mission is to address this problem of a lack of diagnosis during pregnancy, so all parents are aware of congenital problems with their babies, and babies are given the best care right from birth.”
Dr Jackie Matthew, Fraiya’s chief medical officer and clinical academic sonographer, added: “We’re focused on leveraging the unique capabilities of ultrasound and developing solutions to make it smarter, faster, and more reliable, with clinicians at the centre of that transformation. This trial will assess the effectiveness of FraiyaScan in real world conditions. Importantly, the frontline staff and patient feedback will help us to understand the acceptability of the technology, where time-pressured scans, staffing gaps, and service variability, that can affect outcomes, may also impact the performance and adoption of AI-based innovations.”
According to DelveInsight’s “Fetal Monitoring Devices Market Report”, the global fetal monitoring devices market was valued at USD 3.16 billion in 2023, growing at a CAGR of 6.92% during the forecast period from 2024 to 2030 to reach USD 4.72 billion by 2030. The increase in demand for fetal monitoring devices is primarily attributed to the increased need for monitoring fetus for various birth defects and prevalence of preterm births, post-term pregnancy, development of technologically advanced fetal monitors, growing adoption of minimally invasive procedures, and increase in government and non-government initiatives for maternal and fetal health across the world are anticipated to bolster the market, thereby contributing to the growth of the fetal monitoring devices market during the forecast period from 2024-2030.
On September 4, 2025, Medtronic announced the results of the Enable Hernia Repair clinical study, which evaluated the performance of its Hugo™ robotic-assisted surgery (RAS) system in inguinal and ventral hernia repair procedures. Marking a significant milestone, Enable Hernia Repair is the first-ever Investigational Device Exemption (IDE) clinical study completed for robotic-assisted hernia surgery in the United States. The study successfully met its primary safety and effectiveness endpoints, reinforcing the potential of the Hugo RAS system for use in hernia repair procedures.
“The Enable Hernia Repair clinical study didn’t just meet primary endpoints, it far surpassed them,” said Dr. Jacob Greenberg, national principal investigator of the Enable Hernia Repair study and gastrointestinal surgeon at Duke University Hospital. “I am proud to have had the opportunity to advance clinical research in robotic-assisted surgery for the benefit of patients in the United States and around the world.”
The Enable Hernia Repair study was a prospective, multi-center, single-arm pivotal trial that enrolled 193 patients undergoing robotic-assisted inguinal or ventral hernia repair using the Medtronic Hugo™ RAS system. The study successfully met its primary effectiveness endpoint, demonstrating a surgical success rate of 100%, which significantly exceeded the pre-specified performance goal of 85% (p<0.0001). Safety outcomes were also achieved across both cohorts, which were analyzed independently. In the inguinal group, comprising 92 patients, the surgical site event (SSE) rate was 0.0%, well below the 30% performance goal (p<0.0001). In the ventral group, which included 94 patients, the SSE rate was 2.1%, also far lower than the 30% threshold (p<0.0001). Notably, the two SSEs reported in this cohort were resolved without complications.
“The addition of the Hugo platform to our field introduces exciting new opportunities to innovate and advance robotics in the best interests of patients, surgeons, and hospital systems while clearly offering the clinical results we expect from robotic-assisted surgery,” said Dr. David Chen, a general surgeon at UCLA and lead presenter of the Enable Hernia Repair data at the American Hernia Society (AHS) meeting in Nashville, Tenn.
“We’re grateful for the opportunity to partner with clinical teams to treat this common and often painful condition for millions of patients around the world,” said Rajit Kamal, vice president and general manager of Robotic Surgical Technologies within the Surgical business of Medtronic. “Adding a digitally-powered robotic-assisted surgery system to our laparoscopic and open surgery solutions for hernia repair gives surgeons more choice and patients greater access to the care they need and we believe that’s a win for everyone.”
The study adds to the growing body of evidence supporting Hugo, including the Expand URO U.S. clinical trial, which successfully met its safety and effectiveness endpoints, as well as nearly 300 independent publications from surgeons utilizing the Hugo RAS system.
As per DelveInsight’s “Surgical Robotic System Market Report”, the surgical robotic systems market was valued at USD 11,082.32 million in 2024, growing at a CAGR of 13.21% during the forecast period from 2025 to 2032 to reach USD 29,785.13 million by 2032. The rising incidence of chronic disorders such as cancer, cardiovascular diseases, and orthopedic conditions is significantly boosting the demand for advanced surgical interventions, thereby propelling the growth of the surgical robotic systems market. As chronic conditions often require complex, high-precision surgeries, robotic-assisted procedures offer enhanced accuracy, minimal invasiveness, and quicker recovery times, making them highly suitable for treating such ailments. Simultaneously, the increasing number of surgical procedures globally, driven by a growing aging population and a higher prevalence of lifestyle-related health issues, is further escalating the need for efficient and precise surgical tools. In response, key market players are heavily investing in product development activities, focusing on innovations such as compact robotic platforms, AI integration, and enhanced visualization systems. These advancements not only expand the scope of robotic surgery across specialties but also improve surgical outcomes, thereby contributing to the growth of the surgical robotic systems market during the forecast period from 2025 to 2032.
On September 9, 2025, Willow Innovations, Inc. (Willow), a pioneer in Femtech and creator of the first fully in-bra wearable breast pump, is once again transforming the pumping experience with its latest breakthrough. The company has introduced Willow Wave, the world’s first and only wearable manual breast pump, engineered to provide unmatched mobility, comfort, and convenience, setting a new benchmark for manual pumping freedom.
In the U.S., more than two-thirds of breastfeeding mothers (68%) own a manual pump¹, underscoring its importance as a staple tool. Yet, manual pump technology has remained virtually unchanged for over 20 years. As a result, many mothers find traditional models cumbersome and frustrating to use. In surveys, women reported dissatisfaction stemming from issues such as a lack of discretion, awkward handle operation, and bulky, outdated designs.
“At Willow, we are relentlessly focused on designing products with women’s experience at the center. We don’t accept the status quo as ‘good enough’ especially when product categories haven’t been reimagined for decades,” said Sarah O’Leary, CEO of Willow. “Just as we reimagined – and transformed – the electric breast pump category with the world’s first in-bra wearable, we’ve built a manual pump that gives women pumping freedom without compromising output, comfort, or discretion. Willow Wave reinforces our commitment to elevate the experience for moms, one innovation at a time.”
The Willow Wave, inspired by moms’ favorite wearable breast pump, the Willow Go®, combines the trusted comfort and fit of Willow’s patented cup design to give mothers the freedom to pump on their own terms, without compromise. Designed to fit discreetly and fully in bra, it allows for mobility and convenience, eliminating the need to remove clothing while manually pumping. Its features include a comfortable ergonomic handle that minimizes hand fatigue and accommodates various hand sizes, along with hospital-strength suction and dual pumping modes to ensure optimal milk output while quickly relieving engorgement and clogged ducts. The soft silicone flange is crafted to suit a wide range of nipple anatomies, including elastic nipples, ensuring a gentle and secure fit. A 5 oz. container with a splashguard and easy-pour spout prevents leaks and spills, while the adjustable 34” tubing between the pump cup and handle provides maximum movement. Additionally, moms can access expert-backed guidance and personalized support through the Willow app, enhancing the overall pumping experience.
“Creating Willow Wave required us to rethink how manual pumps are used. Women told us the experience can be clunky and awkward, but they also love the portable nature and functionality of manual pumps, especially while traveling or in an emergency situation,” said Lauren Scocozza, Vice President of Product at Willow. “We reinvented the manual pump the Willow way – fully in-bra for ultimate mobility, with a quiet, ergonomic handle for comfort and ease of use, and unique hospital-grade, two-phase suction for optimized output. Moms have not seen anything like Willow Wave, marking the beginning of a new era for breastfeeding and the category.”
According to DelveInsight’s “Breast Pumps Market Report”, the breast pumps market was valued at USD 1,081.96 million in 2023, growing at a CAGR of 8.67% during the forecast period from 2024 to 2030 to reach USD 1,776.50 million by 2030. The breast pumps market is witnessing a positive growth owing to various key factors, such as a surge in the number of employed mothers globally, technological advancements in the product offering, a change in consumer lifestyle, and increasing awareness for breast pumps, thereby all factors are contributing to the growth of the breast pumps market during the forecast period from 2024 to 2030.
On September 9, 2025, Vivalink, a leading provider of digital healthcare solutions, announced the commercial launch of its new wearable ECG sensor adhesive designed to improve p-wave detection during ambulatory cardiac monitoring. Since abnormalities in p-waves are key predictors of conditions such as atrial fibrillation, ischemic stroke, and even sudden cardiac death, this advancement represents a critical step in enhancing early intervention and improving patient outcomes. Serving as a companion to Vivalink’s rechargeable and reusable multi-vital ECG patch, the adhesive significantly strengthens data quality in both clinical care and research settings.
The upgraded adhesive incorporates several important features, including a modified Lead placement for clearer p-wave visibility, a single-use design with up to seven days of water-resistant wear, and a contoured structure that enhances both comfort and flexibility during movement. It is validated for use in remote as well as in-person clinical trial environments. When worn vertically on the center chest above the sternum, the adhesive improves p-wave signal detection by up to 160%, enabling clearer assessment of atrial health. Since even subtle changes in p-wave morphology can indicate early signs of atrial disease, the adhesive plays a vital role in supporting timely clinical decisions related to arrhythmias and atrial fibrillation risk. Leveraging Vivalink’s patented eSkin™ technology, the design ensures user comfort while maintaining high signal integrity, extending the company’s portfolio of innovative adhesive solutions for wearable monitoring.
The adhesive integrates seamlessly with Vivalink’s multi-vital ECG patch, a lightweight, reusable, and rechargeable cardiac monitor designed for continuous ECG and multi-parameter monitoring across clinical care, remote patient monitoring, and research applications. The patch streams live ECG signals along with vital signs such as heart rate, respiratory rate, and skin temperature, while also storing data locally to prevent disruptions during network outages. With a battery life supporting up to two weeks of use between charges, the patch enables extended, unobtrusive monitoring without interfering with daily patient activities, thereby improving compliance and data reliability.
“Continual innovation in wearable monitoring technology is at the core of our mission,” said Jiang Li, CEO of Vivalink. “By improving p-wave signal clarity, this new adhesive advances the accuracy and reliability of cardiac monitoring. The result is better support for clinicians in identifying arrhythmias early, while easing the burden on patients through comfortable, long-term use in ambulatory settings, hospital-at-home programs and clinical trials that demand accurate ECG data.”
According to DelveInsight’s “ECG Monitoring Equipment Market Report”, the Electrocardiogram (ECG) monitoring equipment market was valued at USD 4.44 billion in 2023, growing at a CAGR of 5.74% during the forecast period from 2024 to 2030 to reach USD 6.20 billion by 2030. The global increase in the incidence of cardiovascular diseases (CVDs) due to lifestyle changes, smoking, lack of physical activities, excessive alcohol consumption, obesity, and other factors is escalating the global market of Electrocardiogram (ECG) monitoring equipment.
Additionally, public health campaigns and initiatives aimed at raising awareness about cardiovascular health encourage individuals to undergo regular check-ups and screenings. Increased public knowledge about the importance of early detection and management of heart diseases leads to higher utilization of cardiovascular imaging services. Furthermore, key market players are continuously investing in research and development to introduce innovative Electrocardiogram (ECG) monitoring equipment, increasing partnerships and collaborations, product launches, and approvals, ensuring that the market remains dynamic and innovative during the forecast period from 2024 to 2030.
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Sep 11, 2025
Table of Contents
On September 8, 2025, ONWARD Medical N.V., a leading neurotechnology company developing therapies to restore movement, function, and independence for individuals with spinal cord injuries (SCI) and other mobility impairments, announced that it has received CE Mark certification for its ARC-EX System under the European Union Medical Device Regulation (MDR). This milestone enables the company to commercialize the ARC-EX System across the European Union and in select other countries.
The certification permits ONWARD Medical to market the ARC-EX System for use alongside functional task practice to enhance hand strength and sensation in adults living with a chronic, non-progressive neurological deficit caused by an incomplete spinal cord injury (C2–C8). Approved for both clinical and home use, the ARC-EX System is a non-invasive device that delivers programmed, transcutaneous electrical spinal cord stimulation through electrodes applied to the back of the neck.
“Hand sensation and strength is a primary recovery target after spinal cord injury. The ARC-EX Therapy opens new doors for the SCI community in Europe, offering opportunities for recovery and care that were previously unavailable,” said Dave Marver, Chief Executive Officer of ONWARD Medical. “The CE Mark certification for ARC-EX was awarded far earlier than expected and it gives us great satisfaction to bring this important new therapeutic option to the European spinal cord injury community. We will initiate a phased launch in Europe in the coming weeks, starting with Germany, and cascading to other countries as soon as possible thereafter.”
The ARC-EX System is backed by a robust body of clinical evidence. Findings from the Up-LIFT pivotal study, published in Nature Medicine, revealed that 90% of participants experienced improved strength or function, while 87% reported a better quality of life, with benefits observed even up to 34 years post-injury. Additional outcomes included reduced spasm frequency, enhanced sleep quality, and improved upper body sensation and tactile perception.
Further support came from the investigator-sponsored Pathfinder2 Study, published in Neuromodulation: Technology at the Neural Interface, which demonstrated that ARC-EX Therapy, when combined with activity-based rehabilitation, delivered substantial functional gains. After one year of treatment, participants continued to show improvements in upper body strength, trunk control, and balance, with no plateau in therapeutic benefit.
As part of the CE Mark application process, ONWARD Medical secured its first certification under the European Medical Device Regulation (MDR), successfully meeting stringent European standards for patient safety, clinical performance, risk management, and post-market surveillance.
In early 2025, the company began the phased U.S. launch of the ARC-EX System following FDA clearance. ONWARD has since met its commercial objectives for the first half of 2025, driven by strong demand and highly positive feedback from initial users. The ARC-EX System has also earned global recognition, being named one of TIME Magazine’s Best Inventions of 2024 and selected as one of Fast Company’s World Changing Ideas 2025 for its transformative potential in patient care.
As per DelveInsight’s “Spinal Cord Stimulators Market Report,” the spinal cord stimulators market was valued at USD 3,437.62 million in 2024, growing at a CAGR of 9.83% during the forecast period from 2025 to 2032 to reach USD 7,243.98 million by 2032. The spinal cord stimulator market is experiencing significant growth due to the increasing number of patients suffering from chronic pain and neuropathic pain, particularly in areas such as the shoulders, legs, and knees. Moreover, the degenerative spine conditions, such as chronic pain associated with diabetic neuropathy, spinal cord injury, and failed back surgery syndrome, among others, are other contributing factors for market growth. Additionally, favorable government regulations have played a crucial role in accelerating the commercialization and launch of advanced spinal cord stimulation devices. The rising geriatric population, which is more susceptible to chronic and neuropathic conditions, is also contributing to market expansion. These factors, collectively, are expected to propel the growth of the spinal cord stimulator market throughout the forecast period from 2025 to 2032.
On September 8, 2025, Microbot Medical Inc., the developer and manufacturer of the groundbreaking LIBERTY® Endovascular Robotic System, announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for the LIBERTY® System. This milestone makes LIBERTY® the first FDA-cleared, single-use, remotely operated robotic system designed for peripheral endovascular procedures. The clearance paves the way for the Company to commercialize LIBERTY® in the United States, aiming to revolutionize the field by expanding access to advanced robotics without the limitations of traditional capital equipment or specialized infrastructure.
“Obtaining FDA 510(k) clearance for LIBERTY® marks a defining moment for Microbot Medical and, we believe, for the future of endovascular robotics. This achievement validates our mission to expand access to advanced robotic technologies while addressing critical unmet needs and supporting cost-effective healthcare,” commented Harel Gadot, Chairman, CEO & President. “With our commercial readiness strategy being developed and executed since Q2 this year, we believe we are well positioned to accelerate market entry. With FDA clearance, we can now complete the final commercial activities that were contingent on marketing clearance, positioning us to commence commercialization, penetrate the approximately 2.5 million annual U.S. peripheral vascular procedures, and pursue entry into global markets.”
The LIBERTY® pivotal study demonstrated 100% success in robotic navigation to the target with no device-related adverse events. Results further highlighted a 92% relative reduction in physician radiation exposure. Designed for remote operation, the system is expected to enhance ergonomics and help reduce physical strain on healthcare providers. The Company believes LIBERTY® can drive greater procedural efficiency, lower overall costs, and elevate the quality of care. As part of its commercial launch, the Company intends to continue gathering clinical data to further validate LIBERTY®’s benefits.
As per DelveInsight’s “Surgical Robotic System Market Report”, the surgical robotic systems market was valued at USD 11,082.32 million in 2024, growing at a CAGR of 13.21% during the forecast period from 2025 to 2032 to reach USD 29,785.13 million by 2032. The rising incidence of chronic disorders such as cancer, cardiovascular diseases, and orthopedic conditions is significantly boosting the demand for advanced surgical interventions, thereby propelling the growth of the surgical robotic systems market. As chronic conditions often require complex, high-precision surgeries, robotic-assisted procedures, including minimally invasive surgery devices and interventional cardiology/vascular devices, offer enhanced accuracy, minimal invasiveness, and quicker recovery times, making them highly suitable for treating such ailments. Simultaneously, the increasing number of surgical procedures globally, driven by a growing aging population and a higher prevalence of lifestyle-related health issues, is further escalating the need for efficient and precise surgical tools. In response, key market players are heavily investing in product development activities, focusing on innovations such as compact robotic platforms, AI integration, and advanced visualization systems. These advancements not only expand the scope of robotic surgery across multiple specialties but also improve surgical outcomes, thereby contributing to the growth of the surgical robotic systems market during the forecast period from 2025 to 2032.
On September 9, 2025, Fraiya, a UK-based femtech startup, made significant progress in transforming pregnancy ultrasound with AI. The company achieved several key milestones, including NHS clinical evaluation, regulatory approval, and closing a pre-seed funding round, marking its rise as a strong player in maternal health innovation.
Fraiya’s main product, FraiyaScan, helped clinicians during the 20-week anomaly scan by automating real-time image acquisition, quality checks, measurements, and clinical reporting. Designed in collaboration with the NHS, sonographers, and fetal medicine specialists, the tool integrated smoothly into existing scanning workflows without disrupting routine practice.
Working with King’s College London, Fraiya launched a prospective multi-centre randomised controlled trial of FraiyaScan, along with an AI-assisted second review service, involving over 9,500 pregnant women across four NHS hospitals. This was one of the first large trials evaluating both clinical performance and health economic impact of an AI imaging tool. Funded by the UK’s National Institute for Health and Care Research, the trial measured cost-effectiveness, workflow efficiency, and effects on staff and patient experience.
FraiyaScan received CE-mark Class IIa certification under the EU Medical Device Regulation, approved by Scarlet NB. The regulatory submission was led by Fraiya’s CTO, Dr. Sam Budd, with support from the Medical Engineering Quality and Regulatory Team at King’s, ensuring clinical safety and scalability. This approval allowed commercial use of FraiyaScan in hospitals and clinics across the UK and EU.
The company closed its pre-seed round, raising £3.5 million from grants, awards, VC, and angel investors, including RAW Ventures and Cedars-Sinai Ventures. The funding supported clinical deployment in the UK and EU, further regulatory submissions, and expansion into adjacent product lines.
Fraiya originated from the iFIND project at King’s College London and Imperial College, supported by a £10 million EPSRC and Wellcome Trust innovation grant. The founding team combined expertise in AI, imaging, digital health, and maternal-fetal care. Fraiya also participated in two medtech venture accelerators: the London Institute for Healthcare Engineering and the Cedars-Sinai Accelerator in Los Angeles, focusing on building AI that fits seamlessly into clinical workflows.
Professor Razavi, Friaya’s CEO and chief investigator of the trial, said: “We see this trial as a turning point. It’s not just about proving our AI tools work, it’s about proving they add value to the health system.“As a clinician who looks after babies with congenital problems, I see the difference between those who are diagnosed in pregnancy and get planned care with parents who are fully informed and prepared for what’s to come, and those who unfortunately were not picked up during the pregnancy scans, who arrive at our hospital very unwell and without a diagnosis, with very anxious parents, and have a more difficult journey. Fraiya’s mission is to address this problem of a lack of diagnosis during pregnancy, so all parents are aware of congenital problems with their babies, and babies are given the best care right from birth.”
Dr Jackie Matthew, Fraiya’s chief medical officer and clinical academic sonographer, added: “We’re focused on leveraging the unique capabilities of ultrasound and developing solutions to make it smarter, faster, and more reliable, with clinicians at the centre of that transformation. This trial will assess the effectiveness of FraiyaScan in real world conditions. Importantly, the frontline staff and patient feedback will help us to understand the acceptability of the technology, where time-pressured scans, staffing gaps, and service variability, that can affect outcomes, may also impact the performance and adoption of AI-based innovations.”
According to DelveInsight’s “Fetal Monitoring Devices Market Report”, the global fetal monitoring devices market was valued at USD 3.16 billion in 2023, growing at a CAGR of 6.92% during the forecast period from 2024 to 2030 to reach USD 4.72 billion by 2030. The increase in demand for fetal monitoring devices is primarily attributed to the increased need for monitoring fetus for various birth defects and prevalence of preterm births, post-term pregnancy, development of technologically advanced fetal monitors, growing adoption of minimally invasive procedures, and increase in government and non-government initiatives for maternal and fetal health across the world are anticipated to bolster the market, thereby contributing to the growth of the fetal monitoring devices market during the forecast period from 2024-2030.
On September 4, 2025, Medtronic announced the results of the Enable Hernia Repair clinical study, which evaluated the performance of its Hugo™ robotic-assisted surgery (RAS) system in inguinal and ventral hernia repair procedures. Marking a significant milestone, Enable Hernia Repair is the first-ever Investigational Device Exemption (IDE) clinical study completed for robotic-assisted hernia surgery in the United States. The study successfully met its primary safety and effectiveness endpoints, reinforcing the potential of the Hugo RAS system for use in hernia repair procedures.
“The Enable Hernia Repair clinical study didn’t just meet primary endpoints, it far surpassed them,” said Dr. Jacob Greenberg, national principal investigator of the Enable Hernia Repair study and gastrointestinal surgeon at Duke University Hospital. “I am proud to have had the opportunity to advance clinical research in robotic-assisted surgery for the benefit of patients in the United States and around the world.”
The Enable Hernia Repair study was a prospective, multi-center, single-arm pivotal trial that enrolled 193 patients undergoing robotic-assisted inguinal or ventral hernia repair using the Medtronic Hugo™ RAS system. The study successfully met its primary effectiveness endpoint, demonstrating a surgical success rate of 100%, which significantly exceeded the pre-specified performance goal of 85% (p<0.0001). Safety outcomes were also achieved across both cohorts, which were analyzed independently. In the inguinal group, comprising 92 patients, the surgical site event (SSE) rate was 0.0%, well below the 30% performance goal (p<0.0001). In the ventral group, which included 94 patients, the SSE rate was 2.1%, also far lower than the 30% threshold (p<0.0001). Notably, the two SSEs reported in this cohort were resolved without complications.
“The addition of the Hugo platform to our field introduces exciting new opportunities to innovate and advance robotics in the best interests of patients, surgeons, and hospital systems while clearly offering the clinical results we expect from robotic-assisted surgery,” said Dr. David Chen, a general surgeon at UCLA and lead presenter of the Enable Hernia Repair data at the American Hernia Society (AHS) meeting in Nashville, Tenn.
“We’re grateful for the opportunity to partner with clinical teams to treat this common and often painful condition for millions of patients around the world,” said Rajit Kamal, vice president and general manager of Robotic Surgical Technologies within the Surgical business of Medtronic. “Adding a digitally-powered robotic-assisted surgery system to our laparoscopic and open surgery solutions for hernia repair gives surgeons more choice and patients greater access to the care they need and we believe that’s a win for everyone.”
The study adds to the growing body of evidence supporting Hugo, including the Expand URO U.S. clinical trial, which successfully met its safety and effectiveness endpoints, as well as nearly 300 independent publications from surgeons utilizing the Hugo RAS system.
As per DelveInsight’s “Surgical Robotic System Market Report”, the surgical robotic systems market was valued at USD 11,082.32 million in 2024, growing at a CAGR of 13.21% during the forecast period from 2025 to 2032 to reach USD 29,785.13 million by 2032. The rising incidence of chronic disorders such as cancer, cardiovascular diseases, and orthopedic conditions is significantly boosting the demand for advanced surgical interventions, thereby propelling the growth of the surgical robotic systems market. As chronic conditions often require complex, high-precision surgeries, robotic-assisted procedures offer enhanced accuracy, minimal invasiveness, and quicker recovery times, making them highly suitable for treating such ailments. Simultaneously, the increasing number of surgical procedures globally, driven by a growing aging population and a higher prevalence of lifestyle-related health issues, is further escalating the need for efficient and precise surgical tools. In response, key market players are heavily investing in product development activities, focusing on innovations such as compact robotic platforms, AI integration, and enhanced visualization systems. These advancements not only expand the scope of robotic surgery across specialties but also improve surgical outcomes, thereby contributing to the growth of the surgical robotic systems market during the forecast period from 2025 to 2032.
On September 9, 2025, Willow Innovations, Inc. (Willow), a pioneer in Femtech and creator of the first fully in-bra wearable breast pump, is once again transforming the pumping experience with its latest breakthrough. The company has introduced Willow Wave, the world’s first and only wearable manual breast pump, engineered to provide unmatched mobility, comfort, and convenience, setting a new benchmark for manual pumping freedom.
In the U.S., more than two-thirds of breastfeeding mothers (68%) own a manual pump¹, underscoring its importance as a staple tool. Yet, manual pump technology has remained virtually unchanged for over 20 years. As a result, many mothers find traditional models cumbersome and frustrating to use. In surveys, women reported dissatisfaction stemming from issues such as a lack of discretion, awkward handle operation, and bulky, outdated designs.
“At Willow, we are relentlessly focused on designing products with women’s experience at the center. We don’t accept the status quo as ‘good enough’ especially when product categories haven’t been reimagined for decades,” said Sarah O’Leary, CEO of Willow. “Just as we reimagined – and transformed – the electric breast pump category with the world’s first in-bra wearable, we’ve built a manual pump that gives women pumping freedom without compromising output, comfort, or discretion. Willow Wave reinforces our commitment to elevate the experience for moms, one innovation at a time.”
The Willow Wave, inspired by moms’ favorite wearable breast pump, the Willow Go®, combines the trusted comfort and fit of Willow’s patented cup design to give mothers the freedom to pump on their own terms, without compromise. Designed to fit discreetly and fully in bra, it allows for mobility and convenience, eliminating the need to remove clothing while manually pumping. Its features include a comfortable ergonomic handle that minimizes hand fatigue and accommodates various hand sizes, along with hospital-strength suction and dual pumping modes to ensure optimal milk output while quickly relieving engorgement and clogged ducts. The soft silicone flange is crafted to suit a wide range of nipple anatomies, including elastic nipples, ensuring a gentle and secure fit. A 5 oz. container with a splashguard and easy-pour spout prevents leaks and spills, while the adjustable 34” tubing between the pump cup and handle provides maximum movement. Additionally, moms can access expert-backed guidance and personalized support through the Willow app, enhancing the overall pumping experience.
“Creating Willow Wave required us to rethink how manual pumps are used. Women told us the experience can be clunky and awkward, but they also love the portable nature and functionality of manual pumps, especially while traveling or in an emergency situation,” said Lauren Scocozza, Vice President of Product at Willow. “We reinvented the manual pump the Willow way – fully in-bra for ultimate mobility, with a quiet, ergonomic handle for comfort and ease of use, and unique hospital-grade, two-phase suction for optimized output. Moms have not seen anything like Willow Wave, marking the beginning of a new era for breastfeeding and the category.”
According to DelveInsight’s “Breast Pumps Market Report”, the breast pumps market was valued at USD 1,081.96 million in 2023, growing at a CAGR of 8.67% during the forecast period from 2024 to 2030 to reach USD 1,776.50 million by 2030. The breast pumps market is witnessing a positive growth owing to various key factors, such as a surge in the number of employed mothers globally, technological advancements in the product offering, a change in consumer lifestyle, and increasing awareness for breast pumps, thereby all factors are contributing to the growth of the breast pumps market during the forecast period from 2024 to 2030.
On September 9, 2025, Vivalink, a leading provider of digital healthcare solutions, announced the commercial launch of its new wearable ECG sensor adhesive designed to improve p-wave detection during ambulatory cardiac monitoring. Since abnormalities in p-waves are key predictors of conditions such as atrial fibrillation, ischemic stroke, and even sudden cardiac death, this advancement represents a critical step in enhancing early intervention and improving patient outcomes. Serving as a companion to Vivalink’s rechargeable and reusable multi-vital ECG patch, the adhesive significantly strengthens data quality in both clinical care and research settings.
The upgraded adhesive incorporates several important features, including a modified Lead placement for clearer p-wave visibility, a single-use design with up to seven days of water-resistant wear, and a contoured structure that enhances both comfort and flexibility during movement. It is validated for use in remote as well as in-person clinical trial environments. When worn vertically on the center chest above the sternum, the adhesive improves p-wave signal detection by up to 160%, enabling clearer assessment of atrial health. Since even subtle changes in p-wave morphology can indicate early signs of atrial disease, the adhesive plays a vital role in supporting timely clinical decisions related to arrhythmias and atrial fibrillation risk. Leveraging Vivalink’s patented eSkin™ technology, the design ensures user comfort while maintaining high signal integrity, extending the company’s portfolio of innovative adhesive solutions for wearable monitoring.
The adhesive integrates seamlessly with Vivalink’s multi-vital ECG patch, a lightweight, reusable, and rechargeable cardiac monitor designed for continuous ECG and multi-parameter monitoring across clinical care, remote patient monitoring, and research applications. The patch streams live ECG signals along with vital signs such as heart rate, respiratory rate, and skin temperature, while also storing data locally to prevent disruptions during network outages. With a battery life supporting up to two weeks of use between charges, the patch enables extended, unobtrusive monitoring without interfering with daily patient activities, thereby improving compliance and data reliability.
“Continual innovation in wearable monitoring technology is at the core of our mission,” said Jiang Li, CEO of Vivalink. “By improving p-wave signal clarity, this new adhesive advances the accuracy and reliability of cardiac monitoring. The result is better support for clinicians in identifying arrhythmias early, while easing the burden on patients through comfortable, long-term use in ambulatory settings, hospital-at-home programs and clinical trials that demand accurate ECG data.”
According to DelveInsight’s “ECG Monitoring Equipment Market Report”, the Electrocardiogram (ECG) monitoring equipment market was valued at USD 4.44 billion in 2023, growing at a CAGR of 5.74% during the forecast period from 2024 to 2030 to reach USD 6.20 billion by 2030. The global increase in the incidence of cardiovascular diseases (CVDs) due to lifestyle changes, smoking, lack of physical activities, excessive alcohol consumption, obesity, and other factors is escalating the global market of Electrocardiogram (ECG) monitoring equipment.
Additionally, public health campaigns and initiatives aimed at raising awareness about cardiovascular health encourage individuals to undergo regular check-ups and screenings. Increased public knowledge about the importance of early detection and management of heart diseases leads to higher utilization of cardiovascular imaging services. Furthermore, key market players are continuously investing in research and development to introduce innovative Electrocardiogram (ECG) monitoring equipment, increasing partnerships and collaborations, product launches, and approvals, ensuring that the market remains dynamic and innovative during the forecast period from 2024 to 2030.
