The Shape Sensing Co. is seeking investors to fund the productization and FDA clearance of its fiber optic sensor technology for surgical navigation. Austin, Texas-based TSSC wants to raise $10 million in the Series B round, CEO Ryan DeBoer said in an interview with MassDevice. That should be enough for two-and-a-half years of runway, enough […]
Endoscopic
President of Medtronic Gastrointestinal is leaving, replacement named
Gio Di Napoli, president of the Gastrointestinal business at Medtronic , announced today that he is departing his post at the medtech giant. His leaving marks the second departure of a business unit president at Medtronic this month. Ariel Mactavish, president of the company’s Respiratory Interventions unit, also announced that she was leaving the company. […]
Boston Scientific, Scivita partner on endoscopic devices
Boston Scientific and Scivita Medical announced that they entered into an expanded strategic cooperation arrangement focused on endoscopic technology. Scivita, a China-based medtech company, provides minimally invasive diagnosis and treatment solutions. It focuses on R&D and commercialization for medical endoscopes and related products. The company aims to globalize its operations through strategic cooperations with companies […]
Intuitive Ion wins regulatory approval in China
Intuitive Surgical has received approval from regulatory authorities in China to market its Ion surgical robot system. BTIG analyst Ryan Zimmerman said today that the National Medical Products Administration in China approved the system. This occurred through Intuitive’s partnership with Shanghai Fosun Pharmaceutical, a venture established in 2016. The major regulatory nod in China follows […]
Fujifilm wins FDA nod for AI-powered endoscopy tech that could rival Medtronic’s GI Genius
Fujifilm announced today that the FDA granted 510(k) clearance for its CAD Eye AI-powered detection system for endoscopic imaging. CAD Eye enables the real-time detection of colonic mucosal lesions like polyps and adenomas during colonoscopy procedures. It supports endoscopists in detecting and removing pre-cancerous lesions, regardless of size, shape and color. The system enters a […]
BD initiates IDE trial of stent for treating peripheral arterial disease
BD announced today that it enrolled the first patient in a trial of its Vascular Covered Stent for treating peripheral arterial disease (PAD). Franklin Lakes, New Jersey–based BD is evaluating the safety and effectiveness of the stent in its AGILITY FDA investigational device exemption (IDE) trial. The self-expanding, low-profile, polytetrafluoroethylene encapsulated nitinol implant is deployed […]
Endoscopic ultrasound company EndoSound has a new CEO
EndoSound announced today that it appointed Scott Aldrich Jr. as its new CEO in a move that went into effect on Feb. 1. Dr. Stephen Steinberg, who previously served as president and CEO, remains on the Portland, Oregon–based company’s leadership team as chief medical officer. Aldrich most recently served as an independent consultant focusing on […]
Microbot Medical submits surgical robot for FDA IDE
Microbot Medical (Nasdaq:MBOT) announced today that it filed an FDA investigational device exemption (IDE) application for its surgical robot. Braintree, Massachusetts-based Microbot designed the Liberty surgical robot for potential use in neurovascular, cardiovascular and peripheral vascular procedures. The system includes a compact design and remote operating capabilities to reduce radiation exposure and physical strain on […]
Medtronic, Rijnstate enroll first patient in aneurysm repair trial
Medtronic , with Rijnstate, announced today that they enrolled the first patient in the Hercules trial comparing abdominal aortic aneurysm repair methods. Hercules compares endosuture aneurysm repair (ESAR) to standard endovascular aneurysm repair (EVAR). It looks at these methods in patients who have an abdominal aortic aneurysm (AAA) with a wide, infrarenal neck diameter. Abdominal aortic aneurysms […]
FDA approves Gore low-profile balloon-expandable endoprosthesis
W.L. Gore & Associates announced today that it received FDA approval for a lower-profile Viabahn VBX balloon-expandable endoprosthesis. FDA approval builds on the company’s proven VBX stent graft for treating complex vascular disease. The company says it offers the longest balloon-expandable stent on the market (79 mm) and the widest range of stent diameter adjustability. […]
Boston Scientific launches VersaVue single-use flexible cystoscope
Boston Scientific announced today that it began a limited market release of its VersaVue single-use flexible cystoscope. VersaVue expands the company’s product offerings intended to help clinicians diagnose and treat urinary tract conditions. The scope, which received FDA clearance in October, provides visualization of the lining of the bladder and urethra. It displays images to […]