Neovasc (NSDQ:NVCN) annunced that it closed a previously announced registered direct offering worth approximately $11.5 million. The offering includes nearly 3.9 million units, consisting of one common share of the company and three-quarters of one warrant to purchase one common share. Each warrant entitles the holder to acquire one common share of the company at $2.88 […]
Pandemic forces Proteus into bankruptcy
Proteus Digital Health has filed for Chapter 11 bankruptcy protection, noting that its efforts to raise money or sell the company fell victim to the COVID-19 pandemic. The Redwood City, Calif.-based company missed a $100 million funding target in December. Once valued at $1.5 billion, Proteus previously raised $420 million from investors including Novartis Venture […]
Endologix recall of abdominal stent graft system is Class I
Endologix (NSDQ:ELGX) is warning customers that material weakness during the manufacturing process is causing polymer leaks during implantation of its Ovation iX abdominal stent graft system. The FDA today gave the recall a Class I designation — its most serious level. Out of 12,763 Ovation iX systems sold between August 2015 and May 2020, there were […]
Medtech manufacturers must add warning label to drug-eluting PAD devices
UK medtech regulators on Monday announced that manufacturers of paclitaxel-eluting balloons for use in peripheral arteries must add a warning label about the devices’ risks. A meta-analysis published in the Journal of the American Heart Association in 2018 suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for […]
Keystone Heart acquires 510 Kardiac Devices
Keystone Heart today said it has acquired 510 Kardiac Devices for an undisclosed amount. The development-stage 510 Kardiac Devices is currently developing the Lim Transseptal System to meet the demands of left-sided structural heart procedures that require a transeptal approach. The system is important in procedures such as percutaneous treatment of mitral valve disease, percutaneous […]
BioCardia announces $11.5m offering
Heart failure therapy developer BioCardia (OTC:BCDA) announced that it is offering shares of common stock worth $11.5 million. The San Carlos, Calif.-based company is offering nearly 2.9 million shares of its common stock at a $0.001 par value per share. It is also offering an opportunity for certain purchasers whose purchase would otherwise result in it […]
Abiomed appoints new chief medical officer
Abiomed (NSDQ:ABMD) today said it appointed Charles Simonton as VP and chief medical officer. Simonton most recently served as chief medical officer and divisional VP of global medical affairs at Abbott Vascular where he led programs that resulted in FDA approval of carotid stents, MitraClip and Absorb BVS. He has also spent almost 30 years as […]
Medtronic lands CE Mark for Micra AV transcatheter pacing system
Medtronic (NYSE:MDT) announced today that it received CE Mark approval in Europe for its Micra AV transcatheter pacing system (TPS). The Fridley, Minn.-based medtech giant touts its Micra AV as the world’s smallest pacemaker with atrioventricular (AV) synchrony. The system is indicated for treating patients with AV block, adding to its CE Mark-approved leadless pacemaker portfolio. […]
Okami Medical raises $7.2m to support vascular occlusion system
Months after the first use of its LOBO vascular occlusion system on patients, Okami Medical has raised more than $7.2 million. The Aliso Viejo, Calif.–based company raised the money from 18 investors, according to an SEC Form D filed June 10. After securing FDA clearance in late 2019, Okami Medical announced the first use of […]
Support grows for return of medtech reps to hospitals
Twenty-six more medical and surgical societies and healthcare associations have endorsed guidelines for the safe return of medtech company representatives to healthcare facilities during the coronavirus pandemic. The guidance, released in May by AdvaMed, the Association of periOperative Registered Nurses (AORN) and the American Hospital Association (AHA), builds on the April 17 joint statement by AHA, […]
Cardiovascular Systems announces $125m public offering
Cardiovascular Systems (NSDQ:CSII) announced that it commenced an underwritten public offering of common stock shares worth $125 million. In connection with the offering, Cardiovascular Systems (CSI) expects to grant underwriters a 30-day option to purchase up to an additional 15% of the shares being offered as well. All shares will be sold by CSI, according to […]
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