Snippets - A Small piece of News or Article
How Robots Are Introducing A New Dimension To Healthcare Service Delivery
Notizia - Recent Pharma, Healthcare and Biotech Happenings
Jun 26, 2025
Table of Contents
On June 24, 2025, GE HealthCare announced that the U.S. Food and Drug Administration (FDA) approved an updated label for its PET imaging agent Vizamyl™ (flutemetamol F 18 injection), marking a significant advancement in Alzheimer’s disease diagnosis and management. The revised label, now effective, expands the agent’s indications for use by introducing quantification capabilities that allow for a more continuous and objective measurement of beta-amyloid levels in the brain.
This development supports clinicians in monitoring patient response to anti-amyloid therapies, a limitation previously noted in Vizamyl’s usage. Additionally, the updated label permits the use of Vizamyl in predicting the development of dementia or cognitive decline associated with Alzheimer’s disease, selecting appropriate patients for anti-amyloid treatments, and establishing a formal diagnosis. These enhancements empower healthcare providers with improved tools for decision-making and foster greater confidence in diagnosing and managing Alzheimer’s disease, ultimately helping patients and their families receive timely and personalized care.
Click Here To Get the Article in PDF
“The inclusion of quantification and removal of the therapy monitoring limitation from the Vizamyl label is good news for healthcare providers and their patients, further enabling timely and appropriate care decisions,” said Jit Saini, MD, Chief Medical Officer of the Pharmaceutical Diagnostics (PDx) division of GE HealthCare. “These changes pave the way for clinicians to expand their usage of Vizamyl, with meaningful implications for patients and their families— helping provide clearer answers, earlier diagnoses, and enabling more personalized treatment strategies.”
“The use of quantification in amyloid PET imaging has steadily moved from research to clinical practice, where it can aid in more confident and accurate diagnosis,” said Phillip Kuo, MD, PhD, FACR, Professor of Radiology, Section Chief of Nuclear Medicine and Director Theranostics at City of Hope National Medical Center. “Now quantification can also play a critical role in initiating and monitoring amyloid-targeted therapy for Alzheimer’s disease and determining when it can be discontinued.”
The updated label for Vizamyl™ (flutemetamol F 18 injection) also introduces a significant shift in clinical utility by adding an explicit indication for the selection of patients eligible for anti-amyloid therapy. This change aligns with revised diagnostic criteria from the Alzheimer’s Association, which now recognize that an abnormal amyloid PET scan is sufficient to establish a diagnosis of Alzheimer’s disease. As a result, the label removes several previous limitations of use, including the restriction on using Vizamyl for diagnostic purposes. Furthermore, the update eliminates the prior limitation on predicting cognitive decline or progression to dementia. This decision is supported by growing evidence that amyloid-positive PET scans are associated with an increased risk of progression from the early mild cognitive impairment stage to Alzheimer’s dementia. These updates further enhance the role of Vizamyl in early diagnosis, patient selection, and treatment monitoring, reinforcing its value in delivering more precise and timely care.
As per DelveInsight’s “Alzheimer’s Disease Diagnostic Market Report”, the global Alzheimer’s disease (AD) diagnostic market will grow at a CAGR of 10.97% during the forecast period from 2025 to 2032. The Alzheimer’s disease (AD) diagnostic market is observing an optimistic market growth due to factors such as a rise in the regulatory approvals for Alzheimer’s disease (AD) diagnostics across the globe. Further, the rising prevalence of head injuries owing to accidents, workplace injuries, and others, and the rise in the geriatric population will increase the prevalence of Alzheimer’s disease, thereby increasing the demand for Alzheimer’s disease diagnostic devices across the globe. Additionally, the increasing research and development of novel biomarkers, the presence of key players in the market, increasing product launches and approvals, and other factors will create a demand for Alzheimer’s disease diagnostics in the upcoming years. Therefore, the market for Alzheimer’s disease (AD) diagnostics is estimated to grow at a substantial CAGR during the forecast period from 2025 to 2032.
On June 24, 2025, InspireMD, Inc., the developer of the CGuard Prime Carotid Stent System designed to prevent stroke, announced that the U.S. Food and Drug Administration (FDA) granted premarket application (PMA) approval for the device in the United States. This approval is supported by robust clinical evidence from the Company’s C-GUARDIANS pivotal trial, which was first presented at the Leipzig Interventional Course (LINC).
The study enrolled 316 patients across 24 sites in the United States and Europe and evaluated the safety and efficacy of the CGuard Prime system for the treatment of carotid artery stenosis. The results demonstrated best-in-class outcomes, with CGuard Prime achieving the lowest reported rates of major adverse events in any pivotal study of carotid intervention—0.95% at 30 days and 1.93% at one year.
“The C-GUARDIANS clinical trial provides strong scientific evidence to support the neuro-protective benefits of the next generation MicroNet™ mesh technology of the CGuard Prime Carotid Stent System and results are consistent with the large body of evidence from outside of the United States with this device”, said Dr. D. Chris Metzger, System Vascular Chief at OhioHealth. “As U.S. Primary Investigator for this pivotal IDE trial, I am proud of the scientific rigor and integrity of the data, which demonstrates the lowest event rates (stroke, death, and MI to 30 days and ipsilateral stroke at 1 year) ever reported in any trial of carotid revascularization. These excellent results were in patients who were at high risk for carotid endarterectomy, a quarter of whom were symptomatic. CGuard Prime now offers an important frontline, proven technology for treatment of United States patients with obstructive carotid artery disease, and continued benefits to patients worldwide.”
The CGuard Prime Carotid Stent System is a novel mesh-covered carotid stent engineered to enhance patient safety by providing sustained embolic protection. It features a unique design that combines the largest open-cell frame among available carotid stents with the smallest mesh pore size, effectively preventing plaque protrusion through the stent. This advanced configuration offers continuous embolic protection, with clinical evidence demonstrating its durability and effectiveness beyond five years, positioning CGuard Prime as a significant advancement in the treatment of carotid artery stenosis.
As per DelveInsight’s “Carotid Artery Stent Market Report”, the global carotid artery stents market was valued at USD 575.76 million in 2023, growing at a CAGR of 3.21% during the forecast period from 2024 to 2030 to reach USD 718.25 million by 2030. The demand for carotid artery stents is primarily being boosted by the increasing prevalence of cardiovascular disorders such as stroke, ischemic stroke, and Transient Ischemic Attack (TIA), among others. Additionally, the increasing demand for minimally invasive surgical procedures is another key factor influencing the positive growth of the market. Further, rising technological developments in the domain of stents is also contributing to the overall growth of the Carotid Artery Stents market during the forecast period from 2024 to 2030.
On June 23, 2025, AngioDynamics, Inc., a leading medical technology company dedicated to restoring healthy blood flow, expanding cancer treatment options, and enhancing patient quality of life, announced the enrollment of the first patient in the RECOVER-AV clinical trial. This prospective, multi-center, multi-national, single-arm study is evaluating the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System for the treatment of acute, intermediate-risk pulmonary embolism (PE). The launch of the RECOVER-AV trial follows the system’s 510(k) clearance by the U.S. Food and Drug Administration (FDA) in April 2024 and its CE Mark approval in Europe in May 2024. The study aims to further establish the safety and efficacy of the AlphaVac F1885 System to support its broader global adoption and will also assess long-term functional outcomes for patients post-treatment.
The RECOVER-AV clinical trial is enrolling patients with confirmed acute, intermediate-risk pulmonary embolism (PE) at up to 20 hospital-based sites across Europe, Canada, and Hong Kong. The trial’s primary safety endpoint is the incidence of adverse events by type and seriousness over a 12-month period. Patients will be monitored for one year, with functional and quality-of-life outcomes evaluated at both 30 days and 12 months post-treatment. To provide a more comprehensive understanding of long-term recovery following mechanical thrombectomy with the AlphaVac MMA F1885 System, additional assessments such as cardiac MRI and exercise testing will be conducted. The trial is being led by co-Principal Investigators Dr. Erik Klok, Professor of Medicine and Vascular Medicine Specialist at Leiden University Medical Center, and Dr. Andrew Sharp, Professor of Interventional Cardiology at Mater Misericordiae Hospital and University College Dublin.
“The first patient enrollment in the RECOVER-AV trial marks an important step forward as AngioDynamics continues to grow its global clinical presence and commitment to evidence-based care,” said Laura Piccinini, Senior Vice President/General Manager, Cardiovascular and International. “With AlphaVac already 510(k)-cleared in the U.S. and CE-marked in Europe for PE, we’re investing in high-quality data focused on functional recovery and quality of life that will equip clinicians, payers, and patients with even greater confidence in the system’s safe, effective performance and help broaden access to life-saving PE treatment across Europe and the wider global market.”
“Pulmonary embolism continues to be a leading cause of morbidity and mortality across Europe, underscoring the need for treatment strategies that are both safe and effective,” said Professor Klok. “We’re pleased to collaborate with AngioDynamics to generate evidence that could help shape future standards of care for intermediate-risk PE patients.”
The RECOVER-AV study builds on the positive results of AngioDynamics’ U.S.-based APEX-AV trial, which demonstrated that the AlphaVac F1885 System is safe and effective for treating intermediate-risk pulmonary embolism (PE), showing significant improvements in right ventricular function and a notable reduction in clot burden. Following these findings, the AlphaVac F1885 System received CE Mark approval in May 2024 for the non-surgical removal of thrombi or emboli from the pulmonary arteries. Designed to support frontline treatment of PE, the system aims to expand therapeutic options for healthcare providers managing patients with life-threatening venous thromboembolism and to improve outcomes through minimally invasive intervention.
According to DelveInsight’s “Neurovascular Thrombectomy Devices/Neurothrombectomy Devices Market Report”, the global neurovascular thrombectomy devices/neurothrombectomy devices Market was valued at USD 722.78 million in 2023, growing at a CAGR of 6.15% during the forecast period from 2024 to 2030 to reach USD 1033.33 million by 2030. The rise in demand for Neurovascular Thrombectomy Devices/Neurothrombectomy Devices is predominantly attributed to the rising prevalence of neurovascular disorders across the globe, which require Neurovascular Thrombectomy Devices/Neurothrombectomy Devices for their treatment, such as ischemic stroke and hemorrhagic stroke, growing burden of the old age population. In addition, shifting key players’ focus towards the development of technologically advanced products and initiatives to increase awareness regarding neurovascular diseases and their prevention are some of the factors, among others, that are likely to upsurge the market for Neurovascular Thrombectomy Devices/Neurothrombectomy Devices.
On June 25, 2025, Tivic Health® Systems, Inc., a diversified immunotherapeutics company focused on developing treatments that activate immune pathways to combat disease, announced the successful completion of all study visits in its Optimization Study for the company’s patent-pending, non-invasive cervical vagus nerve stimulation (ncVNS) device. This milestone marks a significant step forward in advancing precision bioelectronic therapies. Initial findings from the study underscore the critical role of personalized treatment parameters in maximizing therapeutic efficacy, reinforcing the need for tailored approaches in non-invasive VNS therapies. Tivic anticipates releasing the full study results later this year.
“This study has provided Tivic with key breakthroughs in the scientific understanding of how to most effectively deliver stimulation to the vagus nerve and thereby the modulation of the pathways implicated in many prevalent and debilitating diseases,” stated Tivic Health’s Chief Executive Officer, Jennifer Ernst. “As we prepare to report these new findings, we are more confident than ever that our novel bioelectronic approach to VNS has the potential to form the basis of future compelling and highly differentiated treatments for large patient populations with unmet clinical needs,” added Ernst.
The study was conducted in collaboration with The Feinstein Institute of Bioelectronic Medicine and was designed to identify optimal device parameters—such as frequency, amplitude, electrode positioning, and individual customization—that most effectively influence autonomic nervous system function. These variables have remained underexplored in the context of non-invasive VNS, and this study aims to fill a critical gap in the current research landscape. Early insights from the study were presented at the Sixth Bioelectronic Medicine Summit: Neurotechnologies for Communities & Individuals, held on March 4, 2025, in a poster titled “Autonomic, Cardiac, and Neural Effects from Non-Invasive Cervical Vagus Nerve Stimulation.” The findings reflect Tivic Health’s commitment to advancing personalized bioelectronic solutions that improve patient outcomes and broaden the therapeutic potential of neuromodulation.
According to DelveInsight’s “Vagus Nerve Stimulators Market Report”, the global vagus nerve stimulators market was valued at USD 426.22 million in 2023, growing at a CAGR of 9.06% during the forecast period from 2024 to 2030 to reach USD 717.17 million by 2030. The demand for vagus nerve stimulators is witnessing a surge primarily due to the rising prevalence of neurological diseases such as epilepsy, headache disorders such as migraine, and others that have proven to receive benefit from VNS therapy, increasing popularity of VNS therapy as an alternative or even conjunctive treatment in cases where drug resistance develops, growing research in studying the effects of VNS on other indications such as tinnitus and chronic pain besides the approved ones, technological advancements leading to the development of new products such as non-invasive VNS devices thereby boosting the growth of the vagus nerve stimulators market during the forecast period from 2024 to 2030.
On June 19, 2025, Johnson & Johnson MedTech, a global leader in orthopedic technologies and solutions, announced the launch of its VOLT™ Distal Radius (Wrist) and VOLT™ Proximal Humerus 3.5 Plating Systems, expanding the Variable Angle Optimized Locking Technology (VOLT™) platform. These new offerings are designed to address a critical clinical need in the treatment of two of the most common fractures—those of the distal radius and proximal humerus. Engineered to improve fixation stability, enhance surgical performance, and streamline procedural efficiency, both systems offer surgeons greater flexibility and precision in fracture management. Each system incorporates the same advanced precision-threaded locking technology first introduced in the original VOLT™ platform, which was validated for its reliability and biomechanical performance. With the introduction of these new systems, Johnson & Johnson MedTech continues to broaden its orthopedic portfolio while delivering innovation that supports improved outcomes for patients and expanded options for surgeons.
The VOLT™ Wrist Treatment System was developed in collaboration with the Hand Expert Group within the AO Technical Commission# to address a broad spectrum of distal radius fractures. This comprehensive system includes the innovative VOLT Two-Column Distal Radius Rim Plate, which introduces a new plate geometry specifically engineered to sit more distally in relation to the target distal fragments, enabling improved fragment capture and fixation. Notably, the plate profile were refined to be significantly less prominent in the region of the flexor pollicis longus tendon, aiming to reduce soft tissue irritation and postoperative complications. These design advancements support the treatment of both simple and complex fracture patterns, offering surgeons enhanced versatility and precision in wrist fracture management.
“The new VOLT™ Proximal Humerus 3.5 Plating System provides more versatility andoptions with the integration of variable angle locking technology, redesigned suture holes and broader plate selection,” said Harry Hoyen, M.D., Orthopedic and Hand surgeon in the U.S. and Simon Lambert, Orthopedic and Trauma surgeon in the U.K., who both serve on the Shoulder and Elbow Task Force within the AO Technical Commission.”
“The VOLT™ Wrist Treatment System and VOLT™ Proximal Humerus 3.5 Plating System are not only a testament to advanced engineering but also reflect a deep understanding of the needs of surgeons and patients,” said Aldo Denti, Company Group Chairman, Orthopaedics, Johnson & Johnson MedTech. “These innovations are designed to provide surgeons with the tools necessary to navigate the complexities of upper extremity fractures with confidence.”
Additionally, the VOLT™ Proximal Humerus 3.5 Plating System represents a significant advancement in the treatment of upper arm fractures involving the shoulder joint. This system enhances surgical versatility by incorporating variable angle locking technology, providing surgeons with greater flexibility to adapt screw placement based on individual patient anatomy and fracture complexity. It also offers a broader range of plate length options to accommodate diverse clinical needs. Designed with both functionality and patient comfort in mind, the plate includes strategically placed suture holes to facilitate easier suture passage during soft tissue repair. Furthermore, the VOLT™ Locking Screws feature an atraumatic tip specifically engineered to minimize the risk of soft tissue irritation, underscoring the system’s focus on improved outcomes and reduced postoperative complications.
According to DelveInsight’s “Minimally Invasive Surgical (MIS) Devices Market Report”, the global MIS devices market was valued at USD 28,873.25 million in 2023, growing at a CAGR of 7.38% during the forecast period from 2024 to 2030, to reach USD 42,499 million by 2030. The MIS devices market is witnessing a positive market growth owing to factors such as the rising prevalence of various cancers, such as lung cancer, which accounted for the highest number of cancer-related deaths and highest cancer incidence in 2023, and other indications such as cardiovascular diseases and neurodegenerative diseases, among others. Furthermore, the presence of factors such as growth in the aging population wherein age plays a key role in the development of various indications, is another factor driving the growth of the MIS devices market. Moreover, the technological advancements in product development, such as the development of surgical robots, are further driving the MIS devices market as new products are gaining regulatory approvals and are entering the market.
On June 23, 2025, Johnson & Johnson, a global leader in eye health, announced the launch of ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM, the first and only daily disposable contact lens designed specifically for people with both astigmatism and presbyopia. This innovative lens delivers crisp, clear, and stable vision at all distances and in varying lighting conditions, while providing all-day comfort. ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM is now available in the U.S. and Canada, with the launch of ACUVUE OASYS MAX 1-Day for ASTIGMATISM expected later this summer.
The ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM contact lens incorporates four proprietary technologies that collectively enhance comfort and visual performance. The BLINK STABILIZED Design ensures the lens stays securely in place, preventing vision distortion or blurriness during blinking or head movement. The PUPIL OPTIMIZED Design addresses the evolving visual needs of presbyopia, adapting as patients’ vision changes with age. TearStable Technology maintains lens hydration throughout the day, promoting lasting comfort even at day’s end. Additionally, the OptiBlue Light Filter provides industry-leading protection by filtering 60% of blue-violet light, helping to reduce eye strain and enhance visual clarity. Later this summer, ACUVUE OASYS MAX 1-Day for ASTIGMATISM will also launch in the U.S. and Canada, completing the ACUVUE OASYS MAX 1-Day Family as the first and only comprehensive daily disposable contact lens portfolio on the market. Both lenses are expected to expand to additional international markets throughout 2025 and beyond.
“Building on our legacy of firsts, we are thrilled to launch ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM,” said Peter Menziuso, Company Group Chairman, Vision at Johnson & Johnson. “ACUVUE is the world’s leading contact lens brand and with these new products, we now have the first and only complete family of daily-disposable contact lenses. Clear sight empowers people to live their best lives, and we believe everyone should have the opportunity to achieve it. That’s why we focus our innovation on areas with the greatest unmet needs for patients. Today, we are working to fufill that promise, providing millions of patients with a differentiated ACUVUE experience.”
“Finally, patients with both presbyopia and astigmatism can enjoy the freedom and comfort of a daily disposable lens without compromising the quality of their vision,” said Dr. Mark Wells, “This new lens was designed to help patients who struggle with multiple vision correction issues, allowing them to experience the comfort and clarity of MAX.”
Based on extensive studies, 95% of people wearing ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM contact lenses reported experiencing clear vision during their daily activities, while 87% noted clear vision while driving at night. Additionally, 92% of wearers stated that their eyes felt comfortable throughout the entire day, highlighting the lens’s ability to deliver both visual clarity and lasting comfort.
As per DelveInsight’s “Intraocular Lens Market Report”, the global intraocular lens market was valued at USD 3.85 billion in 2023, growing at a CAGR of 4.89% during the forecast period from 2024 to 2030 to reach USD 5.13 billion by 2030. The demand for intraocular lenses is witnessing a surge primarily due to the rising eye diseases prevalence, increasing initiatives by various governments across the globe in controlling and treating blindness, technological advancements in IOLs, and the increasing geriatric population who are more susceptible to ocular ailments which are expected to contribute in the growing product demand thereby boosting the growth of the of the intraocular lens market during the forecast period from 2024 to 2030.
Article in PDF
Jun 26, 2025
Table of Contents
On June 24, 2025, GE HealthCare announced that the U.S. Food and Drug Administration (FDA) approved an updated label for its PET imaging agent Vizamyl™ (flutemetamol F 18 injection), marking a significant advancement in Alzheimer’s disease diagnosis and management. The revised label, now effective, expands the agent’s indications for use by introducing quantification capabilities that allow for a more continuous and objective measurement of beta-amyloid levels in the brain.
This development supports clinicians in monitoring patient response to anti-amyloid therapies, a limitation previously noted in Vizamyl’s usage. Additionally, the updated label permits the use of Vizamyl in predicting the development of dementia or cognitive decline associated with Alzheimer’s disease, selecting appropriate patients for anti-amyloid treatments, and establishing a formal diagnosis. These enhancements empower healthcare providers with improved tools for decision-making and foster greater confidence in diagnosing and managing Alzheimer’s disease, ultimately helping patients and their families receive timely and personalized care.
“The inclusion of quantification and removal of the therapy monitoring limitation from the Vizamyl label is good news for healthcare providers and their patients, further enabling timely and appropriate care decisions,” said Jit Saini, MD, Chief Medical Officer of the Pharmaceutical Diagnostics (PDx) division of GE HealthCare. “These changes pave the way for clinicians to expand their usage of Vizamyl, with meaningful implications for patients and their families— helping provide clearer answers, earlier diagnoses, and enabling more personalized treatment strategies.”
“The use of quantification in amyloid PET imaging has steadily moved from research to clinical practice, where it can aid in more confident and accurate diagnosis,” said Phillip Kuo, MD, PhD, FACR, Professor of Radiology, Section Chief of Nuclear Medicine and Director Theranostics at City of Hope National Medical Center. “Now quantification can also play a critical role in initiating and monitoring amyloid-targeted therapy for Alzheimer’s disease and determining when it can be discontinued.”
The updated label for Vizamyl™ (flutemetamol F 18 injection) also introduces a significant shift in clinical utility by adding an explicit indication for the selection of patients eligible for anti-amyloid therapy. This change aligns with revised diagnostic criteria from the Alzheimer’s Association, which now recognize that an abnormal amyloid PET scan is sufficient to establish a diagnosis of Alzheimer’s disease. As a result, the label removes several previous limitations of use, including the restriction on using Vizamyl for diagnostic purposes. Furthermore, the update eliminates the prior limitation on predicting cognitive decline or progression to dementia. This decision is supported by growing evidence that amyloid-positive PET scans are associated with an increased risk of progression from the early mild cognitive impairment stage to Alzheimer’s dementia. These updates further enhance the role of Vizamyl in early diagnosis, patient selection, and treatment monitoring, reinforcing its value in delivering more precise and timely care.
As per DelveInsight’s “Alzheimer’s Disease Diagnostic Market Report”, the global Alzheimer’s disease (AD) diagnostic market will grow at a CAGR of 10.97% during the forecast period from 2025 to 2032. The Alzheimer’s disease (AD) diagnostic market is observing an optimistic market growth due to factors such as a rise in the regulatory approvals for Alzheimer’s disease (AD) diagnostics across the globe. Further, the rising prevalence of head injuries owing to accidents, workplace injuries, and others, and the rise in the geriatric population will increase the prevalence of Alzheimer’s disease, thereby increasing the demand for Alzheimer’s disease diagnostic devices across the globe. Additionally, the increasing research and development of novel biomarkers, the presence of key players in the market, increasing product launches and approvals, and other factors will create a demand for Alzheimer’s disease diagnostics in the upcoming years. Therefore, the market for Alzheimer’s disease (AD) diagnostics is estimated to grow at a substantial CAGR during the forecast period from 2025 to 2032.
On June 24, 2025, InspireMD, Inc., the developer of the CGuard Prime Carotid Stent System designed to prevent stroke, announced that the U.S. Food and Drug Administration (FDA) granted premarket application (PMA) approval for the device in the United States. This approval is supported by robust clinical evidence from the Company’s C-GUARDIANS pivotal trial, which was first presented at the Leipzig Interventional Course (LINC).
The study enrolled 316 patients across 24 sites in the United States and Europe and evaluated the safety and efficacy of the CGuard Prime system for the treatment of carotid artery stenosis. The results demonstrated best-in-class outcomes, with CGuard Prime achieving the lowest reported rates of major adverse events in any pivotal study of carotid intervention—0.95% at 30 days and 1.93% at one year.
“The C-GUARDIANS clinical trial provides strong scientific evidence to support the neuro-protective benefits of the next generation MicroNet™ mesh technology of the CGuard Prime Carotid Stent System and results are consistent with the large body of evidence from outside of the United States with this device”, said Dr. D. Chris Metzger, System Vascular Chief at OhioHealth. “As U.S. Primary Investigator for this pivotal IDE trial, I am proud of the scientific rigor and integrity of the data, which demonstrates the lowest event rates (stroke, death, and MI to 30 days and ipsilateral stroke at 1 year) ever reported in any trial of carotid revascularization. These excellent results were in patients who were at high risk for carotid endarterectomy, a quarter of whom were symptomatic. CGuard Prime now offers an important frontline, proven technology for treatment of United States patients with obstructive carotid artery disease, and continued benefits to patients worldwide.”
The CGuard Prime Carotid Stent System is a novel mesh-covered carotid stent engineered to enhance patient safety by providing sustained embolic protection. It features a unique design that combines the largest open-cell frame among available carotid stents with the smallest mesh pore size, effectively preventing plaque protrusion through the stent. This advanced configuration offers continuous embolic protection, with clinical evidence demonstrating its durability and effectiveness beyond five years, positioning CGuard Prime as a significant advancement in the treatment of carotid artery stenosis.
As per DelveInsight’s “Carotid Artery Stent Market Report”, the global carotid artery stents market was valued at USD 575.76 million in 2023, growing at a CAGR of 3.21% during the forecast period from 2024 to 2030 to reach USD 718.25 million by 2030. The demand for carotid artery stents is primarily being boosted by the increasing prevalence of cardiovascular disorders such as stroke, ischemic stroke, and Transient Ischemic Attack (TIA), among others. Additionally, the increasing demand for minimally invasive surgical procedures is another key factor influencing the positive growth of the market. Further, rising technological developments in the domain of stents is also contributing to the overall growth of the Carotid Artery Stents market during the forecast period from 2024 to 2030.
On June 23, 2025, AngioDynamics, Inc., a leading medical technology company dedicated to restoring healthy blood flow, expanding cancer treatment options, and enhancing patient quality of life, announced the enrollment of the first patient in the RECOVER-AV clinical trial. This prospective, multi-center, multi-national, single-arm study is evaluating the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System for the treatment of acute, intermediate-risk pulmonary embolism (PE). The launch of the RECOVER-AV trial follows the system’s 510(k) clearance by the U.S. Food and Drug Administration (FDA) in April 2024 and its CE Mark approval in Europe in May 2024. The study aims to further establish the safety and efficacy of the AlphaVac F1885 System to support its broader global adoption and will also assess long-term functional outcomes for patients post-treatment.
The RECOVER-AV clinical trial is enrolling patients with confirmed acute, intermediate-risk pulmonary embolism (PE) at up to 20 hospital-based sites across Europe, Canada, and Hong Kong. The trial’s primary safety endpoint is the incidence of adverse events by type and seriousness over a 12-month period. Patients will be monitored for one year, with functional and quality-of-life outcomes evaluated at both 30 days and 12 months post-treatment. To provide a more comprehensive understanding of long-term recovery following mechanical thrombectomy with the AlphaVac MMA F1885 System, additional assessments such as cardiac MRI and exercise testing will be conducted. The trial is being led by co-Principal Investigators Dr. Erik Klok, Professor of Medicine and Vascular Medicine Specialist at Leiden University Medical Center, and Dr. Andrew Sharp, Professor of Interventional Cardiology at Mater Misericordiae Hospital and University College Dublin.
“The first patient enrollment in the RECOVER-AV trial marks an important step forward as AngioDynamics continues to grow its global clinical presence and commitment to evidence-based care,” said Laura Piccinini, Senior Vice President/General Manager, Cardiovascular and International. “With AlphaVac already 510(k)-cleared in the U.S. and CE-marked in Europe for PE, we’re investing in high-quality data focused on functional recovery and quality of life that will equip clinicians, payers, and patients with even greater confidence in the system’s safe, effective performance and help broaden access to life-saving PE treatment across Europe and the wider global market.”
“Pulmonary embolism continues to be a leading cause of morbidity and mortality across Europe, underscoring the need for treatment strategies that are both safe and effective,” said Professor Klok. “We’re pleased to collaborate with AngioDynamics to generate evidence that could help shape future standards of care for intermediate-risk PE patients.”
The RECOVER-AV study builds on the positive results of AngioDynamics’ U.S.-based APEX-AV trial, which demonstrated that the AlphaVac F1885 System is safe and effective for treating intermediate-risk pulmonary embolism (PE), showing significant improvements in right ventricular function and a notable reduction in clot burden. Following these findings, the AlphaVac F1885 System received CE Mark approval in May 2024 for the non-surgical removal of thrombi or emboli from the pulmonary arteries. Designed to support frontline treatment of PE, the system aims to expand therapeutic options for healthcare providers managing patients with life-threatening venous thromboembolism and to improve outcomes through minimally invasive intervention.
According to DelveInsight’s “Neurovascular Thrombectomy Devices/Neurothrombectomy Devices Market Report”, the global neurovascular thrombectomy devices/neurothrombectomy devices Market was valued at USD 722.78 million in 2023, growing at a CAGR of 6.15% during the forecast period from 2024 to 2030 to reach USD 1033.33 million by 2030. The rise in demand for Neurovascular Thrombectomy Devices/Neurothrombectomy Devices is predominantly attributed to the rising prevalence of neurovascular disorders across the globe, which require Neurovascular Thrombectomy Devices/Neurothrombectomy Devices for their treatment, such as ischemic stroke and hemorrhagic stroke, growing burden of the old age population. In addition, shifting key players’ focus towards the development of technologically advanced products and initiatives to increase awareness regarding neurovascular diseases and their prevention are some of the factors, among others, that are likely to upsurge the market for Neurovascular Thrombectomy Devices/Neurothrombectomy Devices.
On June 25, 2025, Tivic Health® Systems, Inc., a diversified immunotherapeutics company focused on developing treatments that activate immune pathways to combat disease, announced the successful completion of all study visits in its Optimization Study for the company’s patent-pending, non-invasive cervical vagus nerve stimulation (ncVNS) device. This milestone marks a significant step forward in advancing precision bioelectronic therapies. Initial findings from the study underscore the critical role of personalized treatment parameters in maximizing therapeutic efficacy, reinforcing the need for tailored approaches in non-invasive VNS therapies. Tivic anticipates releasing the full study results later this year.
“This study has provided Tivic with key breakthroughs in the scientific understanding of how to most effectively deliver stimulation to the vagus nerve and thereby the modulation of the pathways implicated in many prevalent and debilitating diseases,” stated Tivic Health’s Chief Executive Officer, Jennifer Ernst. “As we prepare to report these new findings, we are more confident than ever that our novel bioelectronic approach to VNS has the potential to form the basis of future compelling and highly differentiated treatments for large patient populations with unmet clinical needs,” added Ernst.
The study was conducted in collaboration with The Feinstein Institute of Bioelectronic Medicine and was designed to identify optimal device parameters—such as frequency, amplitude, electrode positioning, and individual customization—that most effectively influence autonomic nervous system function. These variables have remained underexplored in the context of non-invasive VNS, and this study aims to fill a critical gap in the current research landscape. Early insights from the study were presented at the Sixth Bioelectronic Medicine Summit: Neurotechnologies for Communities & Individuals, held on March 4, 2025, in a poster titled “Autonomic, Cardiac, and Neural Effects from Non-Invasive Cervical Vagus Nerve Stimulation.” The findings reflect Tivic Health’s commitment to advancing personalized bioelectronic solutions that improve patient outcomes and broaden the therapeutic potential of neuromodulation.
According to DelveInsight’s “Vagus Nerve Stimulators Market Report”, the global vagus nerve stimulators market was valued at USD 426.22 million in 2023, growing at a CAGR of 9.06% during the forecast period from 2024 to 2030 to reach USD 717.17 million by 2030. The demand for vagus nerve stimulators is witnessing a surge primarily due to the rising prevalence of neurological diseases such as epilepsy, headache disorders such as migraine, and others that have proven to receive benefit from VNS therapy, increasing popularity of VNS therapy as an alternative or even conjunctive treatment in cases where drug resistance develops, growing research in studying the effects of VNS on other indications such as tinnitus and chronic pain besides the approved ones, technological advancements leading to the development of new products such as non-invasive VNS devices thereby boosting the growth of the vagus nerve stimulators market during the forecast period from 2024 to 2030.
On June 19, 2025, Johnson & Johnson MedTech, a global leader in orthopedic technologies and solutions, announced the launch of its VOLT™ Distal Radius (Wrist) and VOLT™ Proximal Humerus 3.5 Plating Systems, expanding the Variable Angle Optimized Locking Technology (VOLT™) platform. These new offerings are designed to address a critical clinical need in the treatment of two of the most common fractures—those of the distal radius and proximal humerus. Engineered to improve fixation stability, enhance surgical performance, and streamline procedural efficiency, both systems offer surgeons greater flexibility and precision in fracture management. Each system incorporates the same advanced precision-threaded locking technology first introduced in the original VOLT™ platform, which was validated for its reliability and biomechanical performance. With the introduction of these new systems, Johnson & Johnson MedTech continues to broaden its orthopedic portfolio while delivering innovation that supports improved outcomes for patients and expanded options for surgeons.
The VOLT™ Wrist Treatment System was developed in collaboration with the Hand Expert Group within the AO Technical Commission# to address a broad spectrum of distal radius fractures. This comprehensive system includes the innovative VOLT Two-Column Distal Radius Rim Plate, which introduces a new plate geometry specifically engineered to sit more distally in relation to the target distal fragments, enabling improved fragment capture and fixation. Notably, the plate profile were refined to be significantly less prominent in the region of the flexor pollicis longus tendon, aiming to reduce soft tissue irritation and postoperative complications. These design advancements support the treatment of both simple and complex fracture patterns, offering surgeons enhanced versatility and precision in wrist fracture management.
“The new VOLT™ Proximal Humerus 3.5 Plating System provides more versatility andoptions with the integration of variable angle locking technology, redesigned suture holes and broader plate selection,” said Harry Hoyen, M.D., Orthopedic and Hand surgeon in the U.S. and Simon Lambert, Orthopedic and Trauma surgeon in the U.K., who both serve on the Shoulder and Elbow Task Force within the AO Technical Commission.”
“The VOLT™ Wrist Treatment System and VOLT™ Proximal Humerus 3.5 Plating System are not only a testament to advanced engineering but also reflect a deep understanding of the needs of surgeons and patients,” said Aldo Denti, Company Group Chairman, Orthopaedics, Johnson & Johnson MedTech. “These innovations are designed to provide surgeons with the tools necessary to navigate the complexities of upper extremity fractures with confidence.”
Additionally, the VOLT™ Proximal Humerus 3.5 Plating System represents a significant advancement in the treatment of upper arm fractures involving the shoulder joint. This system enhances surgical versatility by incorporating variable angle locking technology, providing surgeons with greater flexibility to adapt screw placement based on individual patient anatomy and fracture complexity. It also offers a broader range of plate length options to accommodate diverse clinical needs. Designed with both functionality and patient comfort in mind, the plate includes strategically placed suture holes to facilitate easier suture passage during soft tissue repair. Furthermore, the VOLT™ Locking Screws feature an atraumatic tip specifically engineered to minimize the risk of soft tissue irritation, underscoring the system’s focus on improved outcomes and reduced postoperative complications.
According to DelveInsight’s “Minimally Invasive Surgical (MIS) Devices Market Report”, the global MIS devices market was valued at USD 28,873.25 million in 2023, growing at a CAGR of 7.38% during the forecast period from 2024 to 2030, to reach USD 42,499 million by 2030. The MIS devices market is witnessing a positive market growth owing to factors such as the rising prevalence of various cancers, such as lung cancer, which accounted for the highest number of cancer-related deaths and highest cancer incidence in 2023, and other indications such as cardiovascular diseases and neurodegenerative diseases, among others. Furthermore, the presence of factors such as growth in the aging population wherein age plays a key role in the development of various indications, is another factor driving the growth of the MIS devices market. Moreover, the technological advancements in product development, such as the development of surgical robots, are further driving the MIS devices market as new products are gaining regulatory approvals and are entering the market.
On June 23, 2025, Johnson & Johnson, a global leader in eye health, announced the launch of ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM, the first and only daily disposable contact lens designed specifically for people with both astigmatism and presbyopia. This innovative lens delivers crisp, clear, and stable vision at all distances and in varying lighting conditions, while providing all-day comfort. ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM is now available in the U.S. and Canada, with the launch of ACUVUE OASYS MAX 1-Day for ASTIGMATISM expected later this summer.
The ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM contact lens incorporates four proprietary technologies that collectively enhance comfort and visual performance. The BLINK STABILIZED Design ensures the lens stays securely in place, preventing vision distortion or blurriness during blinking or head movement. The PUPIL OPTIMIZED Design addresses the evolving visual needs of presbyopia, adapting as patients’ vision changes with age. TearStable Technology maintains lens hydration throughout the day, promoting lasting comfort even at day’s end. Additionally, the OptiBlue Light Filter provides industry-leading protection by filtering 60% of blue-violet light, helping to reduce eye strain and enhance visual clarity. Later this summer, ACUVUE OASYS MAX 1-Day for ASTIGMATISM will also launch in the U.S. and Canada, completing the ACUVUE OASYS MAX 1-Day Family as the first and only comprehensive daily disposable contact lens portfolio on the market. Both lenses are expected to expand to additional international markets throughout 2025 and beyond.
“Building on our legacy of firsts, we are thrilled to launch ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM,” said Peter Menziuso, Company Group Chairman, Vision at Johnson & Johnson. “ACUVUE is the world’s leading contact lens brand and with these new products, we now have the first and only complete family of daily-disposable contact lenses. Clear sight empowers people to live their best lives, and we believe everyone should have the opportunity to achieve it. That’s why we focus our innovation on areas with the greatest unmet needs for patients. Today, we are working to fufill that promise, providing millions of patients with a differentiated ACUVUE experience.”
“Finally, patients with both presbyopia and astigmatism can enjoy the freedom and comfort of a daily disposable lens without compromising the quality of their vision,” said Dr. Mark Wells, “This new lens was designed to help patients who struggle with multiple vision correction issues, allowing them to experience the comfort and clarity of MAX.”
Based on extensive studies, 95% of people wearing ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM contact lenses reported experiencing clear vision during their daily activities, while 87% noted clear vision while driving at night. Additionally, 92% of wearers stated that their eyes felt comfortable throughout the entire day, highlighting the lens’s ability to deliver both visual clarity and lasting comfort.
As per DelveInsight’s “Intraocular Lens Market Report”, the global intraocular lens market was valued at USD 3.85 billion in 2023, growing at a CAGR of 4.89% during the forecast period from 2024 to 2030 to reach USD 5.13 billion by 2030. The demand for intraocular lenses is witnessing a surge primarily due to the rising eye diseases prevalence, increasing initiatives by various governments across the globe in controlling and treating blindness, technological advancements in IOLs, and the increasing geriatric population who are more susceptible to ocular ailments which are expected to contribute in the growing product demand thereby boosting the growth of the of the intraocular lens market during the forecast period from 2024 to 2030.
