Nitinotes Received CE Mark Approval of EndoZip™, the First Fully Automated Suturing System for Endoscopic Sleeve Gastroplasty
On November 06, 2025, Nitinotes Ltd., a medical device company focused on transforming obesity treatment, announced that it had received CE Mark approval for its EndoZip™ System, the first fully automated suturing platform designed for endoscopic sleeve gastroplasty (ESG). This regulatory milestone enabled the company to commence commercialization of the system across the European Union and other CE Mark-recognized markets.
At the time, obesity represented one of the most pressing global health challenges, affecting over 650 million adults worldwide. Existing treatment pathways have left a considerable gap between medical therapies, such as GLP-1 drugs, and invasive bariatric surgery. In this context, ESG has been gaining momentum as a minimally invasive alternative, particularly suited for patients with a BMI between 30 and 40 kg/m² who have not achieved sufficient results through lifestyle or pharmacological interventions.
By automating the suturing process, the EndoZip system transformed ESG into a scalable, single-operator, outpatient procedure characterized by shorter procedure times, faster learning curves, and greater reproducibility. In contrast to conventional manual suturing systems that required two physicians, extensive endoscopic skills, and longer operating times, EndoZip offered improved efficiency, consistency, and cost-effectiveness. This innovation helped democratize ESG, broaden access for bariatric surgeons, and set a new standard of care in endoscopic obesity treatment.
Following CE Mark approval, Nitinotes initiated the launch of EndoZip in select European centers of excellence, focusing on building clinical adoption and generating real-world data to support wider market expansion. At the same time, the company prepared for its pivotal U.S. IDE clinical trial, intended to support FDA submission and facilitate entry into the United States the world’s largest obesity treatment market.
“CE Mark approval of EndoZip is a pivotal milestone for Nitinotes,” said Lloyd Diamond, Chief Executive Officer of Nitinotes. “This achievement validates the safety and performance of our technology and paves the way for commercialization in Europe. With EndoZip, we have the potential to dramatically expand patient access to a safe, durable, minimally invasive obesity treatment while creating significant value for providers and healthcare systems.”
As per DelveInsight’s “Surgical Sutures Market Report,” the surgical sutures market is estimated to grow at USD 3,715.95 million in 2024, growing at a CAGR of 6.20% during the forecast period from 2025 to 2032, to reach USD 5,979.12 million by 2032. An increasing aging population and the growing prevalence of diseases such as arthritis, spine deformities, and cardiovascular disorders primarily drive the rising number of surgeries worldwide. These health issues often require surgical intervention, leading to a higher demand for sutures. Additionally, the rise in non-fatal injuries, particularly from sports and accidents, further contributes to the need for surgical procedures and, consequently, sutures. Moreover, key market players are actively engaged in product development activities, introducing advanced suture materials, including bioabsorbable and antimicrobial options, which enhance surgical outcomes and patient safety. This combination of rising surgical procedures, increasing disease prevalence, and continuous innovation in suture technology collectively creates a robust demand for surgical sutures, driving global market growth from 2025 to 2032.
Meduloc Received FDA 510(k) Clearance for Novel Orthopedic Fracture Fixation System
On November 12, 2025, Meduloc, an orthopedic surgical device company, announced that it had received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its proprietary intramedullary fracture fixation system. This regulatory milestone represented a major achievement for the company, as it introduced a new category of fixation technology designed to treat small, long-bone fractures.
The Meduloc system provided surgeons with a distinctive approach to fracture fixation, integrating a durable and flexible nitinol implant with a deployable prong-locking mechanism. This design offered both rotational and length stability, allowing surgeons to avoid entry through the joint capsule —a technique that facilitated earlier mobility, minimized complications, reduced surgical complexity, and promoted faster patient recovery.
The platform was engineered to address multiple indications, including metacarpal, radius, ulna, clavicle, and fibula fractures, and was suitable for both adult and pediatric patients. Following the FDA clearance, Meduloc began preparing for a targeted U.S. commercial launch, while also expanding its network of surgeon advisors and clinical collaborators to encourage adoption and collect real-world clinical data supporting the system’s performance and outcomes.
“An orthopedic surgeon came to us with a problem, and we developed a solution,” said Sarah Sachinis, CEO and President of Meduloc. “We’re excited to bring this innovation to market and empower surgeons with technology that improves their ability to treat patients with small bone fractures more effectively.”
As per DelveInsight’s “Orthopedic Trauma Devices Market Report,” the global orthopedic trauma devices market is expected to increase from USD 11,140.17 million in 2024 to USD 17,551.67 million by 2032, growing at a CAGR of 5.89% during the forecast period from 2025 to 2032. The rising cases of orthopedic injuries, the growing prevalence of degenerative bone-related disorders, continuous technological advancements, and increasing product development activities by key players are collectively driving the growth of the orthopedic trauma devices market. These factors are driving higher demand for advanced, effective, and innovative treatment solutions, leading to improved patient outcomes and wider adoption of trauma devices globally.
Kaneka Expanded Global Reach with i-ED COIL™ Launch in Europe
On November 10, 2025, Kaneka Corporation announced that it had begun sales of its i-ED COIL™, a brain aneurysm embolization coil, in Europe as of October. The product had obtained EC certification under the EU Medical Device Regulation in July, and was distributed primarily across Europe through Kaneka Medical Europe N.V.
The i-ED COIL™ offered world-class flexibility, made possible by its specialized wire thickness and unique structural design. This flexibility allowed coils to be packed more densely within aneurysms than conventional devices, enabling the treatment of aneurysms with irregular shapes. Its effectiveness in lowering the risk of aneurysm rupture had earned strong recognition from physicians. Since its initial launch in Japan in 2019, the product’s sales had continued to grow steadily.
Kaneka had been expanding its business portfolio across various medical fields, including devices for cardiac, peripheral vascular, and cerebrovascular disease treatments, as well as medical technologies used in gastrointestinal procedures. Looking ahead, the company plans to further strengthen the global presence of products such as the i-ED COIL™, aiming to achieve sales of 300 billion yen by 2030 within its Health Care Solution Unit, which encompasses these medical segments.
Guided by its mission, “KANEKA thinks ‘Wellness First,’” the company remained committed to creating a world where advanced medical care is accessible to all and where scientific innovation contributes to global well-being and everyday life.
According to DelveInsight’s “Neurovascular Embolization Devices Market Report,” the neurovascular embolization devices market was valued at USD 1,347.66 million in 2024, growing at a CAGR of 4.40% during the forecast period from 2025 to 2032, to reach USD 1,890.84 million by 2032. The rising prevalence of neurovascular disorders such as aneurysms, severe head injuries, sedentary lifestyles, and ischemic strokes is significantly driving the global market for neurovascular embolization devices. These conditions often require precise, minimally invasive treatments, for which embolization devices are critical. Additionally, the worldwide increase of hypertension, a major risk factor for neurovascular diseases, has led to a higher incidence of brain hemorrhages and aneurysms, further fueling demand for effective embolization solutions.
Motive Health Launched Breakthrough Lower Back Therapy That Delivers Lasting Relief
On November 10, 2025, Motive Health, Inc., an innovative healthcare technology company known for developing the first FDA-cleared muscle stimulation device for knee pain, announced the launch of Motive Lower Back, an FDA-cleared at-home therapy designed to address a key root cause of lower back issues: weak and imbalanced stabilizing muscles.
The new device utilized Motive’s patented neuromuscular electrical stimulation (NMES) technology to target and activate essential muscles across the lower back and glutes, which are vital for maintaining spinal stability. Through this mechanism, it helped relieve tension, enhance mobility, and build long-term muscle strength in convenient 20-minute sessions.
“Lower back discomfort is one of the most common and limiting musculoskeletal conditions we see,” said Dr. Struan Coleman, MD, Ph.D., Sports Medicine Surgeon at Hospital for Special Surgery and Co-Founder of Motive Health. “By strengthening the deep muscles that support the spine, Motive Lower Back offers a safe, easy method to reduce discomfort and stiffness, and return to an active lifestyle.”
Motive Lower Back offered a distinct therapeutic approach, combining short, easy-to-integrate therapy sessions with clinically validated NMES technology, proven to improve muscle performance and recovery, and a non-invasive, drug-free method for alleviating tension, stiffness, and tightness. The device was developed with insights from physicians, physical therapists, and medical specialists, ensuring a clinically sound and patient-centered design that aimed to provide lasting relief from lower back discomfort.
According to DelveInsight’s “Electrical Stimulation Devices Market Report”, the global electrical stimulation devices market will grow at a CAGR of 8.2% during the forecast period from 2024 to 2030. The increase in demand for Electrical Stimulation Devices is primarily due to the rising prevalence of musculoskeletal disorders across the globe. Moreover, the increasing importance of pain management therapies and technological innovation in product development is expected to drive the FES market in the years to come.
Gore Announced Positive Clinical Trial Results of the Investigational Gore® Viabahn® Fortegra Venous Stent for Treatment of Patients With Deep Venous Iliocaval Obstruction
On November 03, 2025, W. L. Gore & Associates’ medical business (Gore) announced the results of its clinical trial evaluating the investigational GORE® VIABAHN® FORTEGRA Venous Stent for the treatment of deep venous iliocaval obstruction. The trial successfully met its primary endpoint, demonstrating the device’s performance over a 12-month period in patients suffering from symptomatic deep venous disease.
The late-breaking data were presented by Dr. Stephen Black, co-primary investigator, at the VEINS Conference in Las Vegas, underscoring Gore’s ongoing commitment to developing advanced solutions for patients with complex venous conditions. The GORE® VIABAHN® FORTEGRA Venous Stent Trial was conducted as an international, multicenter, prospective, non-randomized, single-arm study that enrolled 89 patients diagnosed with deep venous disease. It marked the first prospective study to include treatment across the inferior vena cava (IVC), iliac, and femoral veins. All patients enrolled had thrombotic disease, whether acute, subacute, or chronic/post-thrombotic syndrome. Notably, 94.3% presented with lesions involving all three vessel regions (IVC and bilateral iliofemoral veins), and 68.5% required stents extending below the inguinal ligament into the common femoral vein.
The results showed that 12-month primary patency was achieved in 83.4% of patients, with 96.5% patency in the IVC, 88.9% in the left iliofemoral region, and 89.8% in the right iliofemoral region. Notably, no instances of stent embolization, migration, fracture, vascular injury, or clinically significant pulmonary embolism were observed through 12 months. Additionally, there were no device-related deaths or major bleeding events reported within 30 days.
“These trial results demonstrate promising outcomes for patients with significant iliocaval disease,” said Black, Chief of Surgery with St. Thomas’ Hospital in London. “This is an important step forward in establishing additional treatment options for patients with deep venous obstruction, particularly those with complex anatomy or advanced disease.”
The VIABAHN® FORTEGRA Venous Stent, a self-expanding nitinol venous stent, was designed to restore and maintain patency in the IVC and iliofemoral veins. At the time of the report, the device had not yet received commercial approval and remained under premarket approval (PMA) review by the U.S. Food and Drug Administration (FDA).
According to DelveInsight’s “Peripheral Vascular Devices Market Report,” the global peripheral vascular devices market size is expected to increase from USD 9,853.30 million in 2024 to USD 15,544.32 million by 2032, reflecting strong and sustained growth, growing at a CAGR of 5.92% during the forecast period from 2025 to 2032. The overall market for peripheral vascular devices is being strongly driven by the growing burden of Peripheral Artery Disease (PAD) and other vascular disorders, fueled by risk factors such as diabetes, hypertension, and obesity. Alongside this, the increasing preference for minimally invasive procedures is driving the adoption of advanced devices, such as stents, angioplasty balloons, and EVAR systems, due to their faster recovery times and reduced complications. Continuous technological advancements in product design, including drug-eluting technologies, bioresorbable materials, and imaging-guided delivery systems, are further enhancing treatment outcomes. Additionally, intensified product development activities and innovations by key market players are expanding the portfolio of effective solutions, collectively propelling the growth of the peripheral vascular devices market.
Vexev Completed Enrollment in Study of Robotic Ultrasound for AV Fistula Mapping
On November 10, 2025, Vexev, an Australia-based medical device company focused on next-generation vascular imaging, along with U.S. Renal Care, a leading provider of in-center and home dialysis in the United States, announced that they had completed enrollment in the CANSCAN clinical trial (NCT06691672). This first-of-its-kind, multi-center feasibility study enrolled 120 patients with chronic kidney disease to assess the use of semi-autonomous ultrasound scanning with the VxWave Ultrasound Imaging System for arteriovenous (AV) fistula mapping in dialysis clinics.
The CANSCAN trial was designed to evaluate the VxWave ultrasound imaging system for AV fistula mapping in dialysis settings. Vexev achieved this enrollment milestone in collaboration with U.S. Renal Care. The VxWave system, developed by Vexev in Australia, was a robotic tomographic ultrasound platform created specifically for upper limb vascular imaging. It integrated advanced robotics, machine learning, and ultrasound signal processing to generate a 3D vascular model and comprehensive report, providing detailed insights into vascular access points directly at the point of care.
“Validating this concept is the first step toward a future where intelligent machines can perform high-precision medical imaging without a human hand on the probe,” said Dr. Shannon Thomas, MD, chief medical officer, Vexev. “The potential for a robotic system guided by AI, delivering real clinical value – it’s not science fiction anymore. The real excitement begins when this can change lives, not just lab results. This is a huge step forward in our mission to improve the lives of millions of people worldwide living with end-stage kidney disease.”
According to DelveInsight’s “Ultrasound Devices Market Report”, the global ultrasound devices market size is expected to increase from USD 9,315.06 million in 2024 to USD 13,054.68 million by 2032, growing at a CAGR of 4.38% during the forecast period from 2025 to 2032. The global ultrasound device market is growing due to the rising prevalence of chronic diseases, increasing demand for early and accurate diagnosis, and the expanding use of minimally invasive procedures. Advancements in ultrasound technology, such as 3D/4D imaging, AI integration, and portable handheld systems, are further driving adoption across hospitals, diagnostic centers, and point-of-care settings. The growing awareness of prenatal care and maternal health, coupled with the aging population, has also increased demand for ultrasound in obstetrics and cardiology. Additionally, ultrasound is a cost-effective, safe, and radiation-free imaging modality compared to other diagnostic tools, making it a preferred choice. The expansion of healthcare infrastructure in emerging markets, combined with favorable government initiatives, is further contributing to market growth.
