Route 92 Medical announced that it received FDA 510(k) clearance for its FreeClimb 70 reperfusion system for treating ischemic stroke. San Mateo, California-based Route 92 designed the reperfusion system with the FreeClimb 70 aspiration catheter. It also features a Tenzing 7 delivery catheter. The system enables physicians to treat patients … [Read more...] about Route 92 Medical wins FDA clearance for stroke treatment system
FDA clears iTrack Advance canaloplasty device from Nova Eye Medical
Nova Eye Medical announced today that it received FDA 510(k) clearance for its new iTrack Advance canaloplasty device. The FDA cleared iTrack Advance for microcatheterization and viscodilation to reduce intraocular pressure (IOP). It treats adult patients with primary open-angle glaucoma. Fremont, California-based Nova Eye designed its newest … [Read more...] about FDA clears iTrack Advance canaloplasty device from Nova Eye Medical
Shockwave Medical completes Neovasc acquisition
Shockwave Medical (Nasdaq:SWAV) announced today that it completed its $147 million acquisition of Neovasc. In January, Shockwave announced an agreement to acquire all of the issued and outstanding common shares of Neovasc. The company paid $27.25 per share upfront by way of a statutory plan of arrangement. The deal has an enterprise value of … [Read more...] about Shockwave Medical completes Neovasc acquisition
EvoEndo CEO to leave, replacement named
EvoEndo announced today announced a new CEO and COO along with the departure of previous CEO Heather Underwood. Denver-based EvoEndo, which develops transnasal endoscopy technology, named Jonathan Hartmann as president and CEO. It appointed Ryan Hartman to the COO position. Underwood intends to remain with the company through April to support … [Read more...] about EvoEndo CEO to leave, replacement named
Cook Medical, Vizient ink contract for endoscopy devices
Cook Medical announced today that it received a contract with Vizient covering the company's endoscopy devices. The contract enables Cook to continue offering its endoscopy devices at negotiated pricing terms to Vizient members. “We are honored to have been chosen as an Endoscopy contracted supplier with Vizient," said Rick Simms, Cook … [Read more...] about Cook Medical, Vizient ink contract for endoscopy devices
Getinge’s Datascope has its second Class I recall in a month
The FDA issued a notice determining another recall of Getinge subsidiary Datascope’s Cardiosave intra-aortic balloon pumps (IABPs) as Class I, the most serious kind. This recall relates to the Swedish medtech company’s Cardiosave Hybrid and Cardiosave Rescue IABPs. Both devices were subject to a separate Class I recall earlier this month. The … [Read more...] about Getinge’s Datascope has its second Class I recall in a month
Study backs LimFlow system for treating chronic limb-threatening ischemia
LimFlow announced that new study results demonstrated statistically significant survival with its chronic limb-threatening ischemia (CLTI) treatment. Paris-based LimFlow’s results came from its Promise II U.S. pivotal trial. They were published in today’s issue of the New England Journal of Medicine (NEJM). Data demonstrated 66% amputation-free … [Read more...] about Study backs LimFlow system for treating chronic limb-threatening ischemia
Gore enrolls first U.S. patient in vascular stent trial
W.L. Gore & Associates announced that it enrolled the first U.S. patient in a clinical trial for its Viafort vascular stent. Gore aims to evaluate Viafort for the treatment of symptomatic inferior vena cava (IVC) obstruction with or without iliofemoral obstruction. The prospective, non-randomized, multi-center, single-arm study … [Read more...] about Gore enrolls first U.S. patient in vascular stent trial
Surmodics targets FDA premarket approval for drug-coated balloon in Q4
Surmodics (Nasdaq:SRDX) announced today that it received formal feedback from the FDA related to its SurVeil drug-coated balloon (DCB). Eden Prairie, Minnesota-based Surmodics gave the FDA a proposed approach to submit an amended premarket approval application for SurVeil. In January, the FDA indicated that Surmodics’ SurVeil PMA application is … [Read more...] about Surmodics targets FDA premarket approval for drug-coated balloon in Q4
Some hospitalized patients’ infections may develop from their own bacteria in catheters
Researchers in Missouri discovered evidence of infections forming from hospitalized patients' own bacteria in catheters. Studying mice, researchers at Washington University School of Medicine in St. Louis discovered that urinary tract infections (UTIs) can arise after sterile catheter tube insertion into the urinary tract. This can occur even … [Read more...] about Some hospitalized patients’ infections may develop from their own bacteria in catheters
