Ra Medical Systems (NYSE:RMED) announced today that it priced a public offering of its common stock with gross proceeds expected to reach approximately $10 million. The Carlsbad, Calif.-based company is offering more than 22.2 million shares of common stock (or common stock equivalents) with accompanying warrants to purchase up to 22.2 million shares of common stock, […]
Vascular
Inari Medical plans to launch IPO to raise more than $110m
Inari Medical announced today that it launched the roadshow for its initial public offering (IPO) of shares of its common stock. The venous disease treatment developer is offering more than 7.3 million shares of common stock with an expected additional 30-day option for underwriters to purchase close to 1.1 million more shares. Irvine, Calif.-based Inari […]
Medtronic touts positive results for Melody and Harmony TPVs
Medtronic (NYSE:MDT) today announced the results of two successful clinical trials for its Melody and Harmony transcatheter pulmonary valve (TPV) therapies. The Fridley, Minn.-based medtech giant virtually presented its 10-year outcomes at the 2020 Society for Cardiovascular Angiography & Interventions (SCAI) scientific sessions. Melody demonstrated strong long-term hemodynamic and safety outcomes, while the investigational Harmony TPV […]
FDA labels Applied Medical catheter recall as Class I
The FDA announced today that the Applied Medical recall of multiple kinds of its catheters is designated as Class I, the most serious type of recall. The Python embolectomy catheters, Bard embolectomy catheters and the OTW Latis cleaning catheters were the types recalled by Applied Medical. A total of 19,400 devices were recalled in the […]
CardioFocus wins FDA approval for HeartLight X3 endoscopic ablation system
CardioFocus announced today that it received FDA approval for its next-generation HeartLight X3 endoscopic ablation system. Marlborough, Mass.-based CardioFocus’ system treats drug-refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF). Last year, the company won CE Mark approval in Europe for the device and in February of this year, it announced that it sought out a PMA […]
Control Medical wins 510(k) for blood clot removal device
Control Medical Technology (Park City, Utah) announced today that the FDA has cleared its Aspire MAX 7 – 11F mechanical thrombectomy device to remove blood clots from peripheral vessels. Peripheral thrombectomy is associated with peripheral arterial disease (PAD), acute limb ischemia (ALI), critical limb ischemia (CLI), chronic total occlusion (CTO), deep vein thrombosis (DVT), pulmonary […]
Avinger looks to raise $3.15m
Avinger (NSDQ:AVGR) announced that it priced an underwritten public offering with expected gross proceeds of approximately $3.15 million. The offering includes 12.6 million shares of its treat peripheral artery disease treatment device developer Avinger’s common stock at 25¢ per share with Aegis Capital acting as the sole bookrunner. Redwood City, Calif.-based Avinger earmarked the potential proceeds […]
These medical devices are getting ready to launch in 2020
Despite the COVID-19 pandemic, medical device companies are still working to gain regulatory approvals and launch new devices this year. The pandemic has largely fixed the FDA’s focus on emergency use authorizations (EUAs), leaving more typical device approvals waiting. At press time, the regulatory agency had granted 84 EUAs beginning Feb. 4 and had approved […]
Cagent Vascular wins FDA clearance for balloon catheter
Cagent Vascular announced that it received FDA 510(k) clearance for its Serranator percutaneous transluminal angioplasty (PTA) serration balloon catheter. The FDA indication is for use of the Serranator for treating below-the-knee (BTK) lesions, making it the first and only angioplasty balloon with FDA clearance and CE Mark approval that embeds serration technology into a semi-compliant […]
LivaNova cardiopulmonary devices can be used longer under FDA coronavirus guidance
LivaNova (NSDQ:LIVN) announced that some of its cardiopulmonary products are now permitted for extended use in specific therapies after the FDA expanded device availability amid the COVID-19 pandemic. On April 6, the FDA issued guidance to temporarily expand the availability of certain devices in an effort to address the coronavirus crisis. Along the guidelines given by […]
Abbott’s TriClip tricuspid valve repair system lands CE Mark
Abbott (NYSE:ABT) announced today that its TriClip transcatheter tricuspid valve repair system won CE Mark approval in Europe. Abbott designed TriClip for people with a leaky tricuspid valve, otherwise known as tricuspid regurgitation (TR). The company touts it as the first minimally invasive, clip-based tricuspid valve repair device in the world to be made commercially available. […]