
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.

Neptune Medical has landed an FDA clearance for its robotic system designed to provide stable control during colonoscopy.

Powerful Medical today announced FDA De Novo authorization for its Queen of Hearts AI ECG model.

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.

XCath Robotics has FDA Breakthrough Device Designation for its in-development Iris surgical robotic system for mechanical thrombectomy to treat acute ischemic stroke.

Abbott (NYSE: ABT) announced today that the FDA has approved the smallest version yet of its Aveir leadless pacemakers.

Scholar Rock’s spinal muscular atrophy drug, now to be called Isembyld, was originally rejected in September 2025, when the FDA cited compliance problems at a third-party manufacturer.

The handheld catheterization device AI-GUIDE, created by Lincoln Laboratory and Massachusetts General Hospital, promises improved health outcomes for injured service members and civilians.

LifeTech Scientific, a Shenzhen, China-based developer of advanced minimally invasive medical devices for cardiovascular diseases and disorders, has received CE MDR certification for its self-developed Yuranos abdominal aortic stent graft system, which is indicated for endovascular repair of infrarenal abdominal aortic aneurysms and can be used in combination with the company’s G-iliac iliac bifurcation stent system and SilverFlow iliac artery covered stent system

With the FDA designate in hand, XCath will further the development of its system that is intended to broaden access to stroke treatment globally.

Breakthrough designation for Nutromics’ namesake patch applies to the wearable platform’s function in vancomycin drug monitoring.