Autonomix Medical (Nasdaq:AMIX) has tapped Medtronic’s former chief regulatory counsel, Sandra Cohen Kalter, for its board of directors as it looks to advance its pipeline of catheters for mapping and treating the nervous system. Kalter has served as an advisor to Autonomix’s board for nearly a year. Now with her own seat, the company hopes […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Neptune Medical’s robotic colonoscopy system obtains FDA clearance
Neptune Medical has landed an FDA clearance for its robotic system designed to provide stable control during colonoscopy. The Triton 1 flexible endoscopy system is designed to reach anywhere within the colon for both diagnostic and therapeutic procedures, including screenings for colorectal cancer as well as the removal of early-stage tumors and precancerous growths. According […]
Medtronic grabs FDA clearance to add LigaSure vessel sealer to Hugo
Medtronic (NYSE: MDT) has received an FDA green light to bring its vessel-sealing technology over to its Hugo surgical robot, adding to the platform’s U.S. catalog of energy instruments. The agency’s clearance covers the first version of the LigaSure Maryland jaw device designed specifically for robotic-assisted surgery. According to Medtronic, the hand-held vessel sealer has […]
Abbott wins FDA approval for Aveir VR Mini ventricular leadless pacemaker
Abbott (NYSE: ABT) announced today that the FDA has approved the smallest version yet of its Aveir leadless pacemakers. The Aveir VR Mini ventricular leadless pacemaker is 32.5 mm long, a 14% reduction from the 38.0 mm of the existing Aveir VR ventricular leadless pacemaker. According to Abbott, it designed the system to deliver longevity […]
Powerful Medical announces FDA De Novo nod for AI ECG and other extra medtech news
Powerful Medical today announced FDA De Novo authorization for its Queen of Hearts AI ECG model. According to New York–based Powerful Medical, the AI-powered model is meant to identify ECG findings suggestive of urgent acute coronary syndrome (ACS). The goal is to get urgent notifications to clinicians of suspected cases. According to Powerful Medical, the […]
XCath Robotics receives FDA breakthrough nod for Iris system
XCath Robotics has FDA Breakthrough Device Designation for its in-development Iris surgical robotic system for mechanical thrombectomy to treat acute ischemic stroke. Houston-based XCath says the designation provides increased opportunities to interact with FDA experts and receive support during the regulatory development and review process for Iris. The designation comes about six months after the […]
Intuitive gets expanded indication for da Vinci SP in Europe
Surgical robotics leader Intuitive (NYSE: ISRG) has secured a CE mark covering transvaginal gynecologic procedures for its da Vinci SP surgical system — a world’s first indication for the single-port system. This approval adds to da Vinci SP’s CE-marked existing applications in Europe: endoscopic abdominopelvic, thoracoscopic, transoral otolaryngology, transanal colorectal, and breast surgical procedures. “Building […]
Beta Bionics insulin patch pump scores FDA clearance
Beta Bionics (NASDAQ: BBNX) has claimed an FDA clearance for its first patch pump insulin delivery system, amid plans to roll out an updated diabetes dosing algorithm and the launch of a new CGM partnership with Senseonics. The three-day, wearable Mint carries a 200-unit insulin reservoir as well as a combination of reusable and disposable […]
Luma Vision wins expanded FDA nod for its cardiac procedure software
Luma Vision has won FDA clearance to expand the capabilities of its Verafeye cardiac ablation procedure intelligence platform. The privately held, Dublin, Ireland–based medtech plans to launch commercially in early 2027. The news comes about six months after the company said it was expanding its clinical programs after submitting to the FDA. “By bringing imaging, […]
Johnson & Johnson wins CE mark for new reusable contact lens and other extra medtech news
Johnson & Johnson MedTech (NYSE: JNJ) announced today that it has received a CE mark for its Acuvue Oasys Max 2-Week, a new reusable contact lens. According to J&J, the contact lens features proprietary Max technologies meant to to boost comfort and visual clarity, even at day 14. The company plans to roll out the […]
Ropca wins FDA clearance for ultrasound automation systems
Danish medtech company Ropca will bring its autonomous musculoskeletal ultrasound system to the U.S. after receiving FDA 510(k) clearance. The system features two components: Arthur and Diana, which together capture and analyze ultrasound images of finger, hand and wrist joints. Arthur performs standardized musculoskeletal ultrasound scans, and Diana, an AI software, develops AI-assisted analyses and […]
