Oct 09, 2025
Table of Contents
On October 7, 2025, Vektor Medical, a leading innovator in cardiac arrhythmia care, received CE Mark approval for its vMap® System, a non-invasive, AI-powered technology that converts standard 12-lead ECG data into 3D arrhythmia source maps in under a minute.
Developed to enhance cardiac ablation outcomes in patients with arrhythmias such as atrial fibrillation and ventricular tachycardia, vMap has also demonstrated the ability to reduce total procedure times. Previously available only in the United States, the system has been successfully utilized in over 2,000 procedures across more than 30 hospitals.
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The CE Mark approval paves the way for hospitals and electrophysiologists (EPs) throughout the European Union (EU) to leverage advanced, data-driven insights in arrhythmia management. As healthcare systems increasingly focus on outcome optimization and value-based care, vMap delivers a rapid, non-invasive solution to pinpoint arrhythmia drivers and guide precise treatment strategies. Seamlessly integrating into existing lab workflows, vMap complements current technologies while offering scalable, real-time support for clinical decision-making.
Vektor achieved CE Mark certification through BSI, its Notified Body, under the EU Medical Device Regulation. BSI’s extensive expertise in standards, regulatory compliance, and consulting services ensured an efficient and compliant path to market for the vMap System.
“Electrophysiology labs across Europe are in need of cost-effective ways to improve outcomes of ablation, especially in patients with more complex forms of atrial fibrillation,” said Dr. Lucas Boersma, electrophysiologist, St. Antonius Hospital Nieuwegein. “vMap is emerging as a simple, non-invasive way to gain critical insights upfront and during procedures, supporting more efficient workflows and informed decision-making. By helping clinicians target arrhythmia sources more accurately and optimizing lab time, it has potential to improve outcomes whilst also enhancing the impact of other new approaches like pulsed field ablation. It’s exciting to see this technology now available in Europe.”
The CE Mark milestone comes at a pivotal time in healthcare innovation, coinciding with the rapid commercialization and adoption of pulsed field ablation (PFA). vMap enhances the effectiveness of PFA by providing electrophysiologists with fast, iterative insights into optimal ablation targets both during pre-procedure planning and in the electrophysiology lab thereby supporting more precise and efficient treatment outcomes.
“vMap has shown its impact in the U.S. as a meaningful advancement in arrhythmia care,” said Rob Krummen, CEO of Vektor Medical. “Securing CE Mark under the EU Medical Device Regulation, one of the most rigorous regulatory frameworks in the world, underscores the strength of our technology and quality systems. With regulatory approvals now in place in the U.S. and Europe, we’re well positioned to accelerate adoption and expand access to this innovation globally.”
As per DelveInsight’s “Cardiac Arrhythmia Monitoring Devices Market Report,” the global cardiac arrhythmia monitoring devices market is expected to increase from USD 3,143.72 million in 2024 to USD 9,748.65 million by 2032, reflecting strong and sustained growth. The global cardiac arrhythmia monitoring devices market is projected to grow at a CAGR of 15.23% during the forecast period from 2025 to 2032. The global cardiac arrhythmia monitoring devices market is driven by the increasing global prevalence of arrhythmias, rapid technological advancements like AI-enabled and wearable devices, and the growing adoption of remote patient monitoring models. Favorable regulatory and reimbursement policies in key regions also significantly contribute to improving patient access to these innovative solutions.
On October 6, 2025, Tosoh Bioscience, Inc., a leader in clinical diagnostics, announced that it has received U.S. FDA 510(k) clearance for its next-generation HbA1c testing system, the Tosoh Automated Glycohemoglobin Analyzer HLC®723-GR01 (“GR01”). The GR01 is designed to monitor long-term blood glucose control in individuals with diabetes, support the diagnosis of diabetes, and help identify those at risk for developing the disease.
Featuring a compact footprint, the GR01 is a fully automated analyzer that leverages Tosoh’s proprietary non-porous ion exchange HPLC column technology to deliver accurate and reproducible HbA1c results in just 50 seconds, while also detecting common hemoglobin variants.
The system offers excellent precision with CVs ≤ 1.1% (NGSP Units), providing clinicians with increased confidence in diagnosing and managing diabetes.
Ideal for both mid- and high-volume laboratories, the GR01 combines high throughput speed and efficiency without the complexity or size of larger analyzers. Its automatic buffer change feature ensures a smooth workflow with minimal disruption.
Designed for walk-away operation, the GR01 features an intuitive user interface and seamless integration with Laboratory Information Systems (LIS), helping laboratories save time and reduce labor while maintaining efficient and reliable testing.
“The GR01 is the next step in our legacy of world-renowned analyzers for A1c testing. We are beyond excited to share this system with the community of clinicians working in diabetes management in the United States”, said Jim Shaffer, executive vice president at Tosoh Bioscience, Inc.
According to DelveInsight’s “Diabetes Diagnostics Market Market Report,” the blood gas and electrolyte analyzers market was valued at USD 31 billion in 2024, growing at a CAGR of 7.65% during the forecast period from 2025 to 2032, to reach USD 51.2 billion by 2032. The diabetes diagnostic devices market is primarily driven by the rising prevalence of diabetes worldwide, fueled by increasing obesity rates, sedentary lifestyles, and aging populations. Growing awareness among patients and healthcare providers about the importance of early diagnosis and continuous monitoring of blood glucose levels is also boosting demand for advanced diagnostic devices. Technological advancements, including automated analyzers, point-of-care testing systems, and AI-powered monitoring tools, are enhancing accuracy, efficiency, and convenience, further propelling market growth. Additionally, supportive government initiatives, preventive health programs, and the expansion of healthcare infrastructure in developing regions are increasing access to diagnostic tools. The growing adoption of personalized medicine approaches and chronic disease management strategies also contributes to higher demand, making diabetes diagnostic devices an essential component of effective healthcare delivery.
On October 7, 2025, Zimmer Biomet Holdings, Inc., a global leader in medical technology, announced the completion of its acquisition of Monogram Technologies Inc., an AI-driven, next-generation orthopedic robotics company. Monogram’s surgeon-guided semi- and fully autonomous robotic systems are poised to enhance Zimmer Biomet’s extensive portfolio, bringing innovative and differentiated capabilities to its customer-focused technology solutions.
“By bringing Monogram into the Zimmer Biomet innovation ecosystem, we have set a bold course to become the first orthopedic company to offer a fully autonomous robotic solution complementing our current robotic and navigation offerings,” said Ivan Tornos, Chairman, President, and Chief Executive Officer of Zimmer Biomet. “We aim to provide surgeons the broadest choice in robotics and navigation across a wide range of procedures and care settings. I want to personally welcome the Monogram team to Zimmer Biomet, as their talent and technology will accelerate our innovation pipeline, deepen our value to surgeons and strengthen our long-term growth strategy.”
Zimmer Biomet is further strengthening its orthopedic robotics portfolio with the addition of Monogram Technologies’ CT-based, semi-autonomous, AI-navigated total knee arthroplasty (TKA) robotic system. This technology received FDA 510(k) clearance in March 2025 and is expected to be commercialized with Zimmer Biomet implants by early 2027. Monogram has also initiated a clinical study for the fully autonomous version of its system as of July 2025.
The acquisition enhances Zimmer Biomet’s comprehensive suite of orthopedic robotics, offering surgeons advanced solutions and analytics across the pre-, intra-, and post-operative continuum. Zimmer Biomet’s portfolio now encompasses imageless robotics through the ROSA® Robotics platform, a licensed CT-based handheld robot, mixed reality and AI-based navigation, and Monogram’s semi- and fully autonomous robotic capabilities.
The ROSA platform, a cornerstone of Zimmer Biomet’s robotics offering, is nearing 2,000 installations globally and remains a market leader outside the United States. Zimmer Biomet continues to advance ROSA with a robust R&D pipeline, including several new products and software applications anticipated through 2027. Key developments include the ROSA Knee with OptimiZe™, which has been submitted to the FDA and is expected to receive 510(k) clearance later this year, along with additional upcoming applications.
According to DelveInsight’s “Surgical Robotic System Market Report,” the global 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 October 6, 2025, Olympus Corporation, a global MedTech leader dedicated to enhancing health, safety, and quality of life, entered an international distribution agreement with the medical products division of U.S.-based W. L. Gore & Associates, Inc., a global materials science company known for developing innovative solutions across industries. Under this agreement, Olympus becomes the exclusive international distributor of the GORE® VIABIL® Biliary Endoprosthesis for endoscopic placement. Commercialization is expected to begin in Europe over the coming months, with additional countries being phased in over time. Integrating the GORE® VIABIL® Biliary Endoprosthesis into Olympus’ hepato-pancreato-biliary (HBP) portfolio strengthens its global presence in the rapidly growing gastrointestinal (GI) metal stent market.
The partnership leverages the expertise and technology of both companies, creating opportunities to advance standards of care. Both Olympus and Gore have a proven track record of delivering innovative interventional therapeutic products that improve patient outcomes. By adding the GORE® VIABIL® Biliary Endoprosthesis to its existing range of biliary stents, Olympus provides healthcare professionals with a comprehensive suite of GI devices.
The GORE® VIABIL® Biliary Endoprosthesis is a fully covered, self-expanding metal stent designed to relieve symptoms associated with biliary strictures.* Its user-friendly delivery system and non-foreshortening† design allow for precise deployment. The stent’s non-porous ePTFE/FEP (expanded polytetrafluoroethylene/fluorinated ethylene propylene) lining provides a durable barrier that prevents tumor ingrowth while maintaining a low migration rate, typically seen with covered stents, delivering a reliable and differentiated solution for patients.
“We are thrilled to collaborate with Gore, a global leader in innovative technologies. The VIABIL stent is a critical device for GI patient care, and this agreement will complement our industry leading ERCP portfolio,” said Mike Callaghan, Global SVP/General Manager EndoTherapy for Olympus. “Olympus is committed to helping healthcare organizations and professionals deliver high quality care for their patients, and the relationship with Gore is an important step toward achieving that goal.”
“Gore is pleased to partner with Olympus. We strongly believe the demonstrated commercial prowess of Olympus’ EndoTherapy team will pair nicely with Gore’s medical device innovation expertise to better serve patients with unique solutions for many years to come,” said Jake Goble, Cardiac and Surgical Solutions Business Leader for Gore.
According to DelveInsight’s “Gastrointestinal Endoscopic Stricture Management Devices Market Report”, the global gastrointestinal endoscopic stricture management device market is estimated to grow at a CAGR of 5.36% during the forecast period from 2024 to 2030. The demand for gastrointestinal endoscopic stricture management devices is being boosted by the increasing prevalence of various gastrointestinal (GI) disorders such as colon cancer, rectal cancer, esophageal cancer, gastroesophageal reflux disease (GERD), irritable bowel syndrome (IBS), and others. Further, the rising demand for minimally invasive treatment devices, rising figures of GI disorder-causing risk factors, surging geriatric population base, technological advancements in the device, and increasing product approvals and launches, among others, are thereby contributing to the overall growth of the gastrointestinal endoscopic stricture management device market during the forecast period from 2024 to 2030.
On October 8, 2025, Medtronic launched the Embrace Gynecology investigational device exemption (IDE) clinical study in the U.S. to assess the safety and effectiveness of its Hugo™ robotic-assisted surgery (RAS) system for gynecological procedures.
The study’s first procedures, total hysterectomies, were successfully performed at AHN West Penn Hospital in Pittsburgh, PA, by Dr. Sarah Crafton and Dr. Eirwen Miller, the designated Embrace Gynecology study surgeons at Allegheny Health Network.
Embrace Gynecology is a prospective, multicenter study designed to evaluate the Hugo RAS system during hysterectomy procedures, including radical, modified radical, and total hysterectomies, as well as cases involving malignancies. The study aims to enroll up to 70 patients across as many as five U.S. hospitals.
“We are excited to initiate this important clinical study, which aims to investigate surgical treatment options for women in the U.S.,” said Dr. Emma Rossi, Embrace Gynecology national principal investigator and associate professor of Obstetrics and Gynecology at Duke University in Durham, NC. “In my experience, women facing a gynecologic diagnosis want two things: to treat their condition effectively, and to get back to their whole lives as quickly as possible. Robotic-assisted surgery helps make that possible.
“The study name, Embrace, reflects our deeply felt compassion and care for patients and our commitment to providing access to less invasive treatment options for women,” said Dr. James Porter, chief medical officer of Robotic Surgical Technologies and Digital Technologies within the Surgical business of Medtronic. “We are grateful for the strong partnership with clinical teams at our study sites and share their excitement about this rigorous scientific study that is helping to usher in a new era of choice for patients in the U.S.”
Embrace Gynecology marks the third IDE clinical study for Medtronic’s Hugo™ RAS system in the U.S., underscoring the company’s commitment to securing multiple indications for the platform. The other two U.S. IDE studies, Expand URO and Enable Hernia Repair, successfully met their primary safety and effectiveness endpoints.
In July, positive outcomes from a Medtronic-sponsored prospective study of the Hugo RAS system in benign gynecologic procedures outside the U.S. were presented at the Society of Robotic Surgery congress in Strasbourg, France.
Medtronic’s first U.S. submission for a urology indication is currently under review by the FDA, with an expected completion later in the company’s fiscal year. Subsequent planned expansions are anticipated into hernia repair and gynecology.
Rooted in Medtronic’s 75-year dedication to expanding access to minimally invasive surgical options, the Hugo RAS system is now in clinical use in over 30 countries across five continents, supported by nearly 300 independent publications.
The Hugo RAS system is commercially available in select regions, with regulatory requirements governing approval, clearance, or market access in each jurisdiction. In the EU, it holds CE Mark approval, whereas in the U.S., it remains an investigational device and is not commercially available.
According to DelveInsight’s “Surgical Robotic System Market Report,” the global 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 October 7, 2025, Envoy Medical, Inc., a hearing health company specializing in fully implanted hearing solutions, announced that the U.S. Food and Drug Administration (FDA) has approved the expansion of its pivotal clinical trial for the fully implanted Acclaim® cochlear implant to the final stage. This decision follows encouraging three-month results from the first 10 patients.
FDA approval of the trial expansion removes previous timing uncertainties and strengthens the Company’s path toward regulatory clearance. Consequently, Envoy Medical has accelerated its estimated timeline by three to six months. The updated timeline, combined with operational efficiencies, has enabled management to reduce anticipated capital requirements by $10–$ 15 million.
“The FDA’s granting of our expansion request is a significant and game-changing milestone for Envoy Medical and our fully implanted Acclaim® cochlear implant,” said Brent Lucas, Chief Executive Officer of Envoy Medical. “We believe it is a great sign that we were able to demonstrate to the FDA that our trial data is trending in the right direction and that approving the expansion of the trial to full enrollment was warranted. With the timing of expansion now clear and earlier than originally expected, along with the anticipated rapid enrollment of the remaining participants, we are able to shorten our estimated timeline by at least one full quarter, potentially two. This means we will need less capital as we march toward our goal of changing the hearing industry by redefining the standard of care in cochlear implants.”
The first stage of Envoy Medical’s clinical trial included 10 participants across five U.S. sites. All participants successfully reached the three-month milestone without any serious adverse events (SAEs) or unanticipated device effects (UADEs). Preliminary data demonstrated that the investigational Acclaim® cochlear implant can achieve effectiveness for its intended use, a key requirement for FDA approval of the trial’s expansion. During the three-month visit, participants were tested in the “cochlear implant only” condition, without the use of hearing aids.
The second and final stage of the trial will enroll 46 additional participants at seven U.S. clinical sites. High patient interest has been noted at these sites, and the Company anticipates rapid enrollment over the coming months.
Envoy Medical believes its fully implanted cochlear implant has the potential to address a substantial, underpenetrated market. Of the estimated 2.8 million U.S. adults eligible for cochlear implants, fewer than 5% currently receive them, leaving approximately 95% of potential patients untreated. The Company attributes much of this gap to patients’ preference for avoiding bulky, externally visible devices, as is the case with current partially implanted cochlear implants. By eliminating external hardware, the Acclaim® cochlear implant is designed to overcome these adoption barriers and expand market penetration.
“Prior to joining Envoy Medical, I spent 19 years in a clinic as a cochlear implant audiologist,” said Caroline Arnedt, Director of Audiology of Envoy Medical. “During my prior employment at the clinic, we often saw candidates pass on getting a cochlear implant because they did not want the bulky external hardware on the side of their head. It is a practical reality that some candidates avoid cochlear implants due to the external, wearable component. I firmly believe more candidates will get a cochlear implant once there is a fully implanted option, and that will mean we are helping more people hear by designing a device that patients want.”
According to DelveInsight’s “Cochlear Implants Market Report,” the cochlear implants market was valued at USD 1.38 billion in 2023, growing at a CAGR of 9.92% during the forecast period from 2024 to 2030 to reach USD 2.43 billion by 2030. The cochlear implants market is experiencing substantial growth, primarily driven by the increasing prevalence of hearing loss & which incurs significant economic costs. Investing in cochlear implants & improving access to these devices, along with supportive reimbursement policies, is anticipated to further accelerate the overall growth of the cochlear implants market during the forecast period from 2024 to 2030.
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Oct 09, 2025
Table of Contents
On October 7, 2025, Vektor Medical, a leading innovator in cardiac arrhythmia care, received CE Mark approval for its vMap® System, a non-invasive, AI-powered technology that converts standard 12-lead ECG data into 3D arrhythmia source maps in under a minute.
Developed to enhance cardiac ablation outcomes in patients with arrhythmias such as atrial fibrillation and ventricular tachycardia, vMap has also demonstrated the ability to reduce total procedure times. Previously available only in the United States, the system has been successfully utilized in over 2,000 procedures across more than 30 hospitals.
The CE Mark approval paves the way for hospitals and electrophysiologists (EPs) throughout the European Union (EU) to leverage advanced, data-driven insights in arrhythmia management. As healthcare systems increasingly focus on outcome optimization and value-based care, vMap delivers a rapid, non-invasive solution to pinpoint arrhythmia drivers and guide precise treatment strategies. Seamlessly integrating into existing lab workflows, vMap complements current technologies while offering scalable, real-time support for clinical decision-making.
Vektor achieved CE Mark certification through BSI, its Notified Body, under the EU Medical Device Regulation. BSI’s extensive expertise in standards, regulatory compliance, and consulting services ensured an efficient and compliant path to market for the vMap System.
“Electrophysiology labs across Europe are in need of cost-effective ways to improve outcomes of ablation, especially in patients with more complex forms of atrial fibrillation,” said Dr. Lucas Boersma, electrophysiologist, St. Antonius Hospital Nieuwegein. “vMap is emerging as a simple, non-invasive way to gain critical insights upfront and during procedures, supporting more efficient workflows and informed decision-making. By helping clinicians target arrhythmia sources more accurately and optimizing lab time, it has potential to improve outcomes whilst also enhancing the impact of other new approaches like pulsed field ablation. It’s exciting to see this technology now available in Europe.”
The CE Mark milestone comes at a pivotal time in healthcare innovation, coinciding with the rapid commercialization and adoption of pulsed field ablation (PFA). vMap enhances the effectiveness of PFA by providing electrophysiologists with fast, iterative insights into optimal ablation targets both during pre-procedure planning and in the electrophysiology lab thereby supporting more precise and efficient treatment outcomes.
“vMap has shown its impact in the U.S. as a meaningful advancement in arrhythmia care,” said Rob Krummen, CEO of Vektor Medical. “Securing CE Mark under the EU Medical Device Regulation, one of the most rigorous regulatory frameworks in the world, underscores the strength of our technology and quality systems. With regulatory approvals now in place in the U.S. and Europe, we’re well positioned to accelerate adoption and expand access to this innovation globally.”
As per DelveInsight’s “Cardiac Arrhythmia Monitoring Devices Market Report,” the global cardiac arrhythmia monitoring devices market is expected to increase from USD 3,143.72 million in 2024 to USD 9,748.65 million by 2032, reflecting strong and sustained growth. The global cardiac arrhythmia monitoring devices market is projected to grow at a CAGR of 15.23% during the forecast period from 2025 to 2032. The global cardiac arrhythmia monitoring devices market is driven by the increasing global prevalence of arrhythmias, rapid technological advancements like AI-enabled and wearable devices, and the growing adoption of remote patient monitoring models. Favorable regulatory and reimbursement policies in key regions also significantly contribute to improving patient access to these innovative solutions.
On October 6, 2025, Tosoh Bioscience, Inc., a leader in clinical diagnostics, announced that it has received U.S. FDA 510(k) clearance for its next-generation HbA1c testing system, the Tosoh Automated Glycohemoglobin Analyzer HLC®723-GR01 (“GR01”). The GR01 is designed to monitor long-term blood glucose control in individuals with diabetes, support the diagnosis of diabetes, and help identify those at risk for developing the disease.
Featuring a compact footprint, the GR01 is a fully automated analyzer that leverages Tosoh’s proprietary non-porous ion exchange HPLC column technology to deliver accurate and reproducible HbA1c results in just 50 seconds, while also detecting common hemoglobin variants.
The system offers excellent precision with CVs ≤ 1.1% (NGSP Units), providing clinicians with increased confidence in diagnosing and managing diabetes.
Ideal for both mid- and high-volume laboratories, the GR01 combines high throughput speed and efficiency without the complexity or size of larger analyzers. Its automatic buffer change feature ensures a smooth workflow with minimal disruption.
Designed for walk-away operation, the GR01 features an intuitive user interface and seamless integration with Laboratory Information Systems (LIS), helping laboratories save time and reduce labor while maintaining efficient and reliable testing.
“The GR01 is the next step in our legacy of world-renowned analyzers for A1c testing. We are beyond excited to share this system with the community of clinicians working in diabetes management in the United States”, said Jim Shaffer, executive vice president at Tosoh Bioscience, Inc.
According to DelveInsight’s “Diabetes Diagnostics Market Market Report,” the blood gas and electrolyte analyzers market was valued at USD 31 billion in 2024, growing at a CAGR of 7.65% during the forecast period from 2025 to 2032, to reach USD 51.2 billion by 2032. The diabetes diagnostic devices market is primarily driven by the rising prevalence of diabetes worldwide, fueled by increasing obesity rates, sedentary lifestyles, and aging populations. Growing awareness among patients and healthcare providers about the importance of early diagnosis and continuous monitoring of blood glucose levels is also boosting demand for advanced diagnostic devices. Technological advancements, including automated analyzers, point-of-care testing systems, and AI-powered monitoring tools, are enhancing accuracy, efficiency, and convenience, further propelling market growth. Additionally, supportive government initiatives, preventive health programs, and the expansion of healthcare infrastructure in developing regions are increasing access to diagnostic tools. The growing adoption of personalized medicine approaches and chronic disease management strategies also contributes to higher demand, making diabetes diagnostic devices an essential component of effective healthcare delivery.
On October 7, 2025, Zimmer Biomet Holdings, Inc., a global leader in medical technology, announced the completion of its acquisition of Monogram Technologies Inc., an AI-driven, next-generation orthopedic robotics company. Monogram’s surgeon-guided semi- and fully autonomous robotic systems are poised to enhance Zimmer Biomet’s extensive portfolio, bringing innovative and differentiated capabilities to its customer-focused technology solutions.
“By bringing Monogram into the Zimmer Biomet innovation ecosystem, we have set a bold course to become the first orthopedic company to offer a fully autonomous robotic solution complementing our current robotic and navigation offerings,” said Ivan Tornos, Chairman, President, and Chief Executive Officer of Zimmer Biomet. “We aim to provide surgeons the broadest choice in robotics and navigation across a wide range of procedures and care settings. I want to personally welcome the Monogram team to Zimmer Biomet, as their talent and technology will accelerate our innovation pipeline, deepen our value to surgeons and strengthen our long-term growth strategy.”
Zimmer Biomet is further strengthening its orthopedic robotics portfolio with the addition of Monogram Technologies’ CT-based, semi-autonomous, AI-navigated total knee arthroplasty (TKA) robotic system. This technology received FDA 510(k) clearance in March 2025 and is expected to be commercialized with Zimmer Biomet implants by early 2027. Monogram has also initiated a clinical study for the fully autonomous version of its system as of July 2025.
The acquisition enhances Zimmer Biomet’s comprehensive suite of orthopedic robotics, offering surgeons advanced solutions and analytics across the pre-, intra-, and post-operative continuum. Zimmer Biomet’s portfolio now encompasses imageless robotics through the ROSA® Robotics platform, a licensed CT-based handheld robot, mixed reality and AI-based navigation, and Monogram’s semi- and fully autonomous robotic capabilities.
The ROSA platform, a cornerstone of Zimmer Biomet’s robotics offering, is nearing 2,000 installations globally and remains a market leader outside the United States. Zimmer Biomet continues to advance ROSA with a robust R&D pipeline, including several new products and software applications anticipated through 2027. Key developments include the ROSA Knee with OptimiZe™, which has been submitted to the FDA and is expected to receive 510(k) clearance later this year, along with additional upcoming applications.
According to DelveInsight’s “Surgical Robotic System Market Report,” the global 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 October 6, 2025, Olympus Corporation, a global MedTech leader dedicated to enhancing health, safety, and quality of life, entered an international distribution agreement with the medical products division of U.S.-based W. L. Gore & Associates, Inc., a global materials science company known for developing innovative solutions across industries. Under this agreement, Olympus becomes the exclusive international distributor of the GORE® VIABIL® Biliary Endoprosthesis for endoscopic placement. Commercialization is expected to begin in Europe over the coming months, with additional countries being phased in over time. Integrating the GORE® VIABIL® Biliary Endoprosthesis into Olympus’ hepato-pancreato-biliary (HBP) portfolio strengthens its global presence in the rapidly growing gastrointestinal (GI) metal stent market.
The partnership leverages the expertise and technology of both companies, creating opportunities to advance standards of care. Both Olympus and Gore have a proven track record of delivering innovative interventional therapeutic products that improve patient outcomes. By adding the GORE® VIABIL® Biliary Endoprosthesis to its existing range of biliary stents, Olympus provides healthcare professionals with a comprehensive suite of GI devices.
The GORE® VIABIL® Biliary Endoprosthesis is a fully covered, self-expanding metal stent designed to relieve symptoms associated with biliary strictures.* Its user-friendly delivery system and non-foreshortening† design allow for precise deployment. The stent’s non-porous ePTFE/FEP (expanded polytetrafluoroethylene/fluorinated ethylene propylene) lining provides a durable barrier that prevents tumor ingrowth while maintaining a low migration rate, typically seen with covered stents, delivering a reliable and differentiated solution for patients.
“We are thrilled to collaborate with Gore, a global leader in innovative technologies. The VIABIL stent is a critical device for GI patient care, and this agreement will complement our industry leading ERCP portfolio,” said Mike Callaghan, Global SVP/General Manager EndoTherapy for Olympus. “Olympus is committed to helping healthcare organizations and professionals deliver high quality care for their patients, and the relationship with Gore is an important step toward achieving that goal.”
“Gore is pleased to partner with Olympus. We strongly believe the demonstrated commercial prowess of Olympus’ EndoTherapy team will pair nicely with Gore’s medical device innovation expertise to better serve patients with unique solutions for many years to come,” said Jake Goble, Cardiac and Surgical Solutions Business Leader for Gore.
According to DelveInsight’s “Gastrointestinal Endoscopic Stricture Management Devices Market Report”, the global gastrointestinal endoscopic stricture management device market is estimated to grow at a CAGR of 5.36% during the forecast period from 2024 to 2030. The demand for gastrointestinal endoscopic stricture management devices is being boosted by the increasing prevalence of various gastrointestinal (GI) disorders such as colon cancer, rectal cancer, esophageal cancer, gastroesophageal reflux disease (GERD), irritable bowel syndrome (IBS), and others. Further, the rising demand for minimally invasive treatment devices, rising figures of GI disorder-causing risk factors, surging geriatric population base, technological advancements in the device, and increasing product approvals and launches, among others, are thereby contributing to the overall growth of the gastrointestinal endoscopic stricture management device market during the forecast period from 2024 to 2030.
On October 8, 2025, Medtronic launched the Embrace Gynecology investigational device exemption (IDE) clinical study in the U.S. to assess the safety and effectiveness of its Hugo™ robotic-assisted surgery (RAS) system for gynecological procedures.
The study’s first procedures, total hysterectomies, were successfully performed at AHN West Penn Hospital in Pittsburgh, PA, by Dr. Sarah Crafton and Dr. Eirwen Miller, the designated Embrace Gynecology study surgeons at Allegheny Health Network.
Embrace Gynecology is a prospective, multicenter study designed to evaluate the Hugo RAS system during hysterectomy procedures, including radical, modified radical, and total hysterectomies, as well as cases involving malignancies. The study aims to enroll up to 70 patients across as many as five U.S. hospitals.
“We are excited to initiate this important clinical study, which aims to investigate surgical treatment options for women in the U.S.,” said Dr. Emma Rossi, Embrace Gynecology national principal investigator and associate professor of Obstetrics and Gynecology at Duke University in Durham, NC. “In my experience, women facing a gynecologic diagnosis want two things: to treat their condition effectively, and to get back to their whole lives as quickly as possible. Robotic-assisted surgery helps make that possible.
“The study name, Embrace, reflects our deeply felt compassion and care for patients and our commitment to providing access to less invasive treatment options for women,” said Dr. James Porter, chief medical officer of Robotic Surgical Technologies and Digital Technologies within the Surgical business of Medtronic. “We are grateful for the strong partnership with clinical teams at our study sites and share their excitement about this rigorous scientific study that is helping to usher in a new era of choice for patients in the U.S.”
Embrace Gynecology marks the third IDE clinical study for Medtronic’s Hugo™ RAS system in the U.S., underscoring the company’s commitment to securing multiple indications for the platform. The other two U.S. IDE studies, Expand URO and Enable Hernia Repair, successfully met their primary safety and effectiveness endpoints.
In July, positive outcomes from a Medtronic-sponsored prospective study of the Hugo RAS system in benign gynecologic procedures outside the U.S. were presented at the Society of Robotic Surgery congress in Strasbourg, France.
Medtronic’s first U.S. submission for a urology indication is currently under review by the FDA, with an expected completion later in the company’s fiscal year. Subsequent planned expansions are anticipated into hernia repair and gynecology.
Rooted in Medtronic’s 75-year dedication to expanding access to minimally invasive surgical options, the Hugo RAS system is now in clinical use in over 30 countries across five continents, supported by nearly 300 independent publications.
The Hugo RAS system is commercially available in select regions, with regulatory requirements governing approval, clearance, or market access in each jurisdiction. In the EU, it holds CE Mark approval, whereas in the U.S., it remains an investigational device and is not commercially available.
According to DelveInsight’s “Surgical Robotic System Market Report,” the global 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 October 7, 2025, Envoy Medical, Inc., a hearing health company specializing in fully implanted hearing solutions, announced that the U.S. Food and Drug Administration (FDA) has approved the expansion of its pivotal clinical trial for the fully implanted Acclaim® cochlear implant to the final stage. This decision follows encouraging three-month results from the first 10 patients.
FDA approval of the trial expansion removes previous timing uncertainties and strengthens the Company’s path toward regulatory clearance. Consequently, Envoy Medical has accelerated its estimated timeline by three to six months. The updated timeline, combined with operational efficiencies, has enabled management to reduce anticipated capital requirements by $10–$ 15 million.
“The FDA’s granting of our expansion request is a significant and game-changing milestone for Envoy Medical and our fully implanted Acclaim® cochlear implant,” said Brent Lucas, Chief Executive Officer of Envoy Medical. “We believe it is a great sign that we were able to demonstrate to the FDA that our trial data is trending in the right direction and that approving the expansion of the trial to full enrollment was warranted. With the timing of expansion now clear and earlier than originally expected, along with the anticipated rapid enrollment of the remaining participants, we are able to shorten our estimated timeline by at least one full quarter, potentially two. This means we will need less capital as we march toward our goal of changing the hearing industry by redefining the standard of care in cochlear implants.”
The first stage of Envoy Medical’s clinical trial included 10 participants across five U.S. sites. All participants successfully reached the three-month milestone without any serious adverse events (SAEs) or unanticipated device effects (UADEs). Preliminary data demonstrated that the investigational Acclaim® cochlear implant can achieve effectiveness for its intended use, a key requirement for FDA approval of the trial’s expansion. During the three-month visit, participants were tested in the “cochlear implant only” condition, without the use of hearing aids.
The second and final stage of the trial will enroll 46 additional participants at seven U.S. clinical sites. High patient interest has been noted at these sites, and the Company anticipates rapid enrollment over the coming months.
Envoy Medical believes its fully implanted cochlear implant has the potential to address a substantial, underpenetrated market. Of the estimated 2.8 million U.S. adults eligible for cochlear implants, fewer than 5% currently receive them, leaving approximately 95% of potential patients untreated. The Company attributes much of this gap to patients’ preference for avoiding bulky, externally visible devices, as is the case with current partially implanted cochlear implants. By eliminating external hardware, the Acclaim® cochlear implant is designed to overcome these adoption barriers and expand market penetration.
“Prior to joining Envoy Medical, I spent 19 years in a clinic as a cochlear implant audiologist,” said Caroline Arnedt, Director of Audiology of Envoy Medical. “During my prior employment at the clinic, we often saw candidates pass on getting a cochlear implant because they did not want the bulky external hardware on the side of their head. It is a practical reality that some candidates avoid cochlear implants due to the external, wearable component. I firmly believe more candidates will get a cochlear implant once there is a fully implanted option, and that will mean we are helping more people hear by designing a device that patients want.”
According to DelveInsight’s “Cochlear Implants Market Report,” the cochlear implants market was valued at USD 1.38 billion in 2023, growing at a CAGR of 9.92% during the forecast period from 2024 to 2030 to reach USD 2.43 billion by 2030. The cochlear implants market is experiencing substantial growth, primarily driven by the increasing prevalence of hearing loss & which incurs significant economic costs. Investing in cochlear implants & improving access to these devices, along with supportive reimbursement policies, is anticipated to further accelerate the overall growth of the cochlear implants market during the forecast period from 2024 to 2030.
