4C Medical Technologies announced that it completed an over-subscribed convertible note financing worth $10 million in gross proceeds. Minneapolis-based 4C Medical Technologies said in a news release that an unnamed China-based venture firm led the financing round. The company plans to use the net proceeds from the financing to fund the continued development of its […]
Cardiovascular
TricValve transcatheter bicaval valves system wins FDA breakthrough designation
P+F Products + Features GmbH announced that it received FDA breakthrough device designation for its TricValve system. Vienna-based P+F received the breakthrough nod earlier this month for the transcatheter bicval valves system, comprised of two self-expanding biological valves for the treatment of patients with hemodynamically relevant tricuspid insufficiency and caval reflux, according to a news […]
Report: Higher error rate seen in use of pulse oximeters with Black patients
Pulse oximeters, a handy tool to measure oxygenation issues and elevated heart rates, are reportedly more error-prone with Black patients. The New York Times reported that, based on a study that had its findings shared with the New England Journal of Medicine, the devices can provide misleading results in more than one out of 10 […]
Medtronic gains Health Canada nod for Micra AV pacemaker
Medtronic Canada (NYSE:MDT) announced that it received a Health Canada license for its Micra AV pacemaker with atrioventricular synchrony. Brampton, Ontario-based Medtronic Canada said in a news release that Micra AV is indicated for treating patients with AV block, making it the first and only Health Canada-licensed leadless pacemaker portfolio. The pacemaker won FDA approval in […]
First patients treated with Abiomed ECMO tech
Abiomed (NSDQ:ABMD) announced that it treated the first two patients with its Abiomed Breethe OXY-1 compact cardiopulmonary bypass system. Danvers, Mass.-based Abiomed’s extracorporeal membrane oxygenation (ECMO) technology pumps, oxygenates and removes carbon dioxide from blood for patients whose lungs can’t provide sufficient end-organ oxygenation, according to a news release. Breethe OXY-1 is designed to help oxygenate […]
Edwards treats first patient in mitral valve disease trial
Edwards Lifesciences (NYSE:EW) announced today that it treated the first patient in a clinical trial for its Harpoon valve repair system. Harpoon is an investigational beating heart mitral valve repair system designed with a less invasive technique than open heart surgery for treating severe degenerative mitral valve regurgitation, according to a news release. Irvine, Calif.-based Edwards […]
Health Canada gives Edwards’ Sapien 3 TAVR expanded use nod
Edwards Lifesciences (NYSE:EW) today announced that Health Canada has approved the expanded use of the company’s Sapien 3 and Sapien 3 Ultra transcatheter heart valves to treat patients diagnosed with severe symptomatic aortic stenosis who are at low risk for open-heart surgery. The Sapien 3 valves are the first transcatheter aortic valve replacement (TAVR) systems to […]
Philips to acquire BioTelemetry for $2.47B
Royal Philips (NYSE:PHG) announced today that it agreed to acquire BioTelemetry (NSDQ:BEAT) in a deal worth $2.8 billion. Amsterdam-based Philips is slated to commence a tender offer to acquire all issued and outstanding shares of BioTelemetry for $72 per share, to be paid upon completion. That represents a 16.5% premium to BioTelemetry’s closing price on Dec. 17, […]
FDA approves Abbott Heartmate 3 label update in pediatric patients
Abbott (NYSE:ABT) announced that the FDA approved updated labeling for its HeartMate 3 heart pump for pediatric patients. The heart pump can now be used in pediatric patients with advanced refractory left ventricular heart failure, giving physicians more options for treating the pediatric population awaiting a heart transplant or ineligible for receiving a transplant due to […]
Boston Sci among UBS analysts’ top stock picks for 2021
UBS Investment Bank listed Boston Scientific (NYSE:BSX) among its 21 most compelling stock investment selections for 2021. Marlborough, Mass.-based Boston Scientific was the only medical device company on a list that featured companies such as Amazon, Morgan Stanley and Southwest Airlines. Additionally, Vertex Pharmaceuticals represented the biotech space, while Acadia Healthcare registered for healthcare facilities. UBS […]
Corvion gains FDA breakthrough nod for LVAD
Corvion announced that it received FDA breakthrough device designation for its left ventricular assist device (LVAD). Webster, Texas-based Corvion said in a news release that the breakthrough nod for the fully implanted LVAD device allows the company to move forward with the FDA in addressing topics that arise during development and testing ahead of an […]
