Gore this week announced it enrolled the first U.S. patient in its pivotal study for its ViaFort vascular stent. The prospective, non-randomized, multi-center, single-arm study will have a five-year follow-up and will evaluate the investigational Gore ViaFort vascular stent for the treatment of symptomatic iliofemoral venous obstruction. It will evaluate the device in a treatment […]
Structural Heart
The 10 largest medtech employers — and what their employees really think
Employees of the 10 largest medtech employers are happy to be a part of companies having a positive impact on patient populations. That was one major takeaway as MassDevice compiled some current and former employee reviews posted on Glassdoor. Medtronic, Philips and Johnson & Johnson MedTech top the list of largest medtech employers. The 10 […]
Medtronic has Class I recall for low-shock risk in ICDs
Medtronic (NYSE: MDT) is recalling 22,110 Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) in the U.S. The Class I recall — the most serious classification from the FDA — is due to the potential for reduced shock energy during high-voltage therapy for Cobalt and Crome ICDs and CRT-Ds, according […]
Expect more heart and lung failure years after COVID, Abbott’s heart failure CMO says
Two years into the COVID-19 pandemic, we know more than ever about the SARS-CoV-2 virus and how quickly it moves to ravage the human body. What remains to be seen is how the virus — and perhaps more importantly, our immune system’s response to it — will affect the health of people long after infection, […]
Artio Medical to build manufacturing facilities in Kansas
Artio Medical today announced that it received the green light to build commercial manufacturing operations in Kansas. The city council in Olathe, Kansas approved a development agreement that granted land to Prairie Village, Kansas-based Artio Medical to build two commercial manufacturing buildings. The company plans to build an initial 50,000+ sq. ft facility on the […]
ReValve Solutions completes first successful procedure with TMVR system
ReValve Solutions announced today that it completed the first human use of its transcatheter mitral valve replacement (TMVR) system. Bainbridge Island, Washington-based ReValve Solutions said in a news release that the first procedure with its Palmetto TMVR system was performed at the Italian Hospital in Asuncion, Paraguay, by Dr. Charles Davison (medical director, Bluhm Cardiovascular […]
Edwards Lifesciences reports mixed Q3 financial results
Edwards Lifesciences (NYSE: EW) reported third-quarter financial results that exceeded Wall Street’s expectations on profits but narrowly missed on sales. The Irvine, California–based cardio device company yesterday evening reported earnings of $340.1 million (or 54¢ per share) off sales of $1.31 billion. That’s a 4.6% increase from Q3 2020’s earnings of $325.2 million (52¢ per share) […]
OneProjects raises $17M to advance 4D cardiac imaging
Irish-German cardiac imaging startup OneProjects today announced $8 million in Series A2 funding and two grants totaling $9 million. The company will use the new funds to complete product development, conduct clinical trials, gain FDA clearance and prepare for U.S. commercialization of the first product developed from its proprietary 4D cardiac imaging platform, Verafeye. Get […]
The 18 most innovative medical devices of 2021
The Galien Foundation today announced the nominees for most innovative medical devices for its 15th annual Prix Galien USA Awards. The foundation nominates devices, biotechnology and pharmaceutical products for its annual Prix Galien awards to highlight products designed to improve the human condition. “The Awards Committee is excited to introduce the nominees for the 2021 […]
St. Jude Medical founder and his Medical 21 raise $3M
Raising money for a startup company during a pandemic is no cakewalk, according to Manny Villafaña. But he did it. Medical 21, the latest venture for the founder of St. Jude Medical, has raised another $3 million in an equity offering, according to an SEC filing. The most recent round brings the Minneapolis-based start-up’s total funding […]
Medtronic’s Kowal explains how remote medtech got its groove back
In this week’s DeviceTalks Weekly Podcast, Dr. Robert Kowal CMO of Medtronic’s cardiac rhythm and heart failure business and vice president of medical affairs, explains how new tech, savvy patients, eager physicians and, yes, COVID-19, has fueled a renaissance for remote technology, once seen as a mature, staid business. Kowal, who left clinical practice to […]
