It’s been more than a decade since Lisa Jennings launched not one but two companies in the Great Recession. In 2020, she sold CirQuest Labs to MLM Medical Labs, where Jennings serves as chief scientific officer and managing director of U.S. operations. More recently, her pre-commercial medtech development startup, Ariste Medical, won FDA 510(k) approval for […]
Stents
Boston Scientific pouring €100M into Irish campus
Boston Scientific (NYSE:BSX) has unveiled plans for a €100 million ($118 million) expansion of its operations outside Galway, an Irish economic development agency announced today. IDA Ireland said the project will create more than 300 jobs in the coming years. The construction project will create more than 40,000 ft2 of carbon-neutral medical device manufacturing space […]
Silk Road Medical grows sales 33% in Q4
Silk Road Medical (NSDQ:SILK) posted fourth-quarter results that beat the revenue consensus on Wall Street and missed on earnings estimates. The Sunnyvale, California-based stroke treatment tech company reported losses of -$14.7 million, or -42¢ per share, on sales of $28.3 million for the three months ended Dec. 31, 2021, for a bottom-line gain of 12.3% […]
FDA clears Dyad Medical automated cardiac image analysis platform
Dyad Medical this week announced that it received FDA 510(k) clearance for its Libby IAAA cardiac image analysis platform. Boston-based Dyad Medical designed the Libby IAAA for image analysis used for viewing and quantifying intravascular optical coherence tomography (IVOCT) images. It allows healthcare professionals to automate intravascular investigation and see inside of blood vessels to […]
Cook Medical wins FDA breakthrough designation for new drug-eluting stent
Cook Medical recently announced that it received FDA breakthrough designation for its drug-eluting stent for below the knee. Bloomington, Indiana-based Cook Medical designed the stent to treat patients who have chronic limb-threatening ischemia (CLTI). Get the full story on our sister site, Medical Tubing + Extrusion.
FDA approves Edwards Lifesciences Sapien 3 with Alterra for pulmonary regurgitation
Edwards Lifesciences (NYSE:EW) announced today that it received FDA approval for the use of its Sapien 3 transcatheter valve with the Alterra adaptive prestent. Irvine, California-based Edwards garnered the FDA nod for use of the Sapien 3 with Alterra for patients with severe pulmonary regurgitation. The Sapien 3 transcatheter pulmonary valve (TPV) system combines the […]
Philips to buy Vesper Medical and its advanced venous stent portfolio
Royal Philips announced today that it will acquire Vesper Medical, a Wayne, Pennsylvania–based maker of minimally-invasive peripheral vascular devices. The financial terms of the deal were not disclosed. The purchase will enable the Dutch medtech giant to expand its diagnostic and therapeutic devices portfolio with advanced venous stents. Get the full story on our sister […]
5 pediatric electrophysiology devices you need to know
The National Capital Consortium for Pediatric Device Innovation recently announced five electrophysiology devices that could monitor and treat congenital heart disease and arrhythmia in pediatric patients. The five winners of the annual NCC-PDI “Make Your Medical Device Pitch for Kids!” competition will share a $150,000 FDA grant to support the advancement of pediatric medical devices. […]
FDA clears Avinger’s Pantheris for in-stent restenosis
Avinger this week announced that it received FDA 510(k) clearance for a new clinical indication for its Pantheris image-guided atherectomy system. The new indication allows the Redwood City, California-based company to market the device for in-stent restenosis (ISR) treatment in the lower extremity arteries. Get the full story on our sister site, Medical Tubing + Extrusion.
Matthew Thompson promoted to corner office at Endologix
Dr. Matthew Thompson, who has served as chief medical officer at Endologix since 2016, has been promoted to CEO of the vascular disease treatments company. Richard Mott, who has been serving as interim CEO, will return to his role as executive chair of the company’s board of directors, Endologix announced November 10. On top of […]
Medtronic reports promising early data for transfemoral delivery of its Intrepid TMVR
Medtronic (NYSE:MDT) this week touted data for its Intrepid self-expanding transcatheter mitral valve replacement (TMVR) system. Early data from 15 patients in an early feasibility study was presented as late-breaking clinical science at the 33rd Transcatheter Cardiovascular Therapeutics (TCT) conference, the annual scientific symposium of the Cardiovascular Research Foundation. The study evaluated patients with severe, symptomatic […]