HighLife SAS announced this week that it introduced a new valve size in its clinical trials for treating mitral regurgitation (MR) in larger anatomies. Paris-based HighLife’s latest trans-septal mitral valve replacement (TSMVR) is a large annulus valve (LAV). The company designed it to fit within its existing delivery catheter and to accommodate … [Read more...] about HighLife unveils new large annular valve for mitral regurgitation clinical trials
Rapid Medical wins Chinese approval for adjustable thrombectomy device
Rapid Medical announced that it received Chinese approval for its Tigertriever revascularization device for blood clot removal. Yokneam, Israel-based Rapid Medical designed Tigertriever to remove thrombus from delicate brain blood vessels during an ischemic stroke. With National Medical Product Administration (NMPA) approval, it becomes the … [Read more...] about Rapid Medical wins Chinese approval for adjustable thrombectomy device
GLP-1 startup i2o looks to revive diabetes drug-eluting implant from Intarcia
i2o Therapeutics says it acquired the diabetes-treating assets of one-time medtech unicorn Intarcia Therapeutics. The Boston-based company acquired and integrated Intarcia’s proprietary assets and made a big personnel move. With CEO Ravi Srinivasan moving onto other opportunities, i2o named Kurt Graves as chair, president and CEO. Graves … [Read more...] about GLP-1 startup i2o looks to revive diabetes drug-eluting implant from Intarcia
FDA approves next-gen Watchman FLX Pro from Boston Scientific
A string of positive news continues for Boston Scientific (NYSE: BSX), which this week announced FDA approval for its next-generation Watchman FLX. Last week, the company reported positive data for its Farapulse system, which led to a favorable reaction from analysts and the market. Just the week before, Boston Scientific received expanded FDA … [Read more...] about FDA approves next-gen Watchman FLX Pro from Boston Scientific
FDA fast-tracks aneurysm stabilization system from Nectero Medical
Nectero Medical announced today that the FDA granted fast track designation to its endovascular aneurysm stabilization treatment (EAST) system. Tempe, Arizona-based Nectero designed its EAST system to treat patients with abdominal aortic aneurysm (AAA). These AAAs have a maximum diameter of 3.5 cm to 5 cm. The company plans to initiate a … [Read more...] about FDA fast-tracks aneurysm stabilization system from Nectero Medical
Advanced NanoTherapies picks up $4M investment for drug-coated balloon development
Advanced NanoTherapies announced today that it collected a $4 million Series A extension from an undisclosed strategic investor. Los Gatos, California-based Advanced NanoTherapies received the investment from a medical device company. It also announced the successful treatment of the first cohort of study participants in its drug-coated balloon … [Read more...] about Advanced NanoTherapies picks up $4M investment for drug-coated balloon development
Teleflex extends Arrow ErgoPack system with hemodialysis, large bore catheters
Teleflex (NYSE:TFX) announced today that it released its Arrow ErgoPack complete kits with hemodialysis and large-bore catheters in the U.S. Wayne, Pennsylvania-based Teleflex launched this update to streamline insertion workflow for clinicians. The company also says it provides more options to suit their particular needs. Clinicians can now … [Read more...] about Teleflex extends Arrow ErgoPack system with hemodialysis, large bore catheters
BD enrolls first patient in study of stent graft for treating portal hypertension
BD (NYSE:BDX) announced today that it completed the enrollment of the first patient in a trial of its Liverty TIPS stent graft. Franklin Lakes, New Jersey-based BD's ARCH FDA investigational device exemption (IDE) study evaluates the safety and effectiveness of Liverty. The global, prospective, multi-center, single-arm clinical study looks at … [Read more...] about BD enrolls first patient in study of stent graft for treating portal hypertension
Baird Medical submits disposable microwave ablation needle for FDA clearance
Baird Medical announced today that it submitted its disposable microwave ablation (MWA) needle system to the FDA for 510(k) clearance. Guangzhou, China-based Baird submitted the system in search of an indication for soft tissue microwave ablation. The FDA's Center for Devices and Radiologic Health (CDRH) accepted the submission last month. … [Read more...] about Baird Medical submits disposable microwave ablation needle for FDA clearance
FDA approves POLARx cryoablation system from Boston Scientific
Boston Scientific [WtwhTicker symbol="BSX"](NYSE: BSX)[/WtwhTicker] announced today that it received FDA approval for its POLARx cryoablation system. The new system received an indication for the treatment of patients with paroxysmal AFib. It features the POLARx FIT cryoablation balloon catheter. This device enables two balloon sizes (28 mm and … [Read more...] about FDA approves POLARx cryoablation system from Boston Scientific
