Ra Medical Systems (NYSE:RMED) announced today that it received notice that is is no longer in compliance with the New York Stock Exchange’s listing standards. The Carlsbad, Calif.-based company learned that it is not complying with the NYSE continued listing standard that requires companies to maintain an average closing share price of at least $1 over […]
Catheters
Ra Medical Systems prices $10m public offering
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, […]
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 […]
Edwards lands CE Mark for Pascal transcatheter valve repair system to treat TR
Edwards Lifesciences (NYSE:EW) announced today that it received CE Mark approval for its Pascal transcatheter valve repair system for treating tricuspid regurgitation (TR). Pascal won its indication in Europe for the percutaneous reconstruction of the tricuspid valve through leaflet repair by tissue approximation. The device uses clasps and paddles to grasp the leaflets and facilitate coaptation, […]
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 […]
Smiths Medical acquires Access Scientific
Smiths Medical announced today that it acquired the business of broad-spectrum vascular access and infection prevention company Access Scientific. Financial details of the acquisition were not released. San Diego-based Access Scientific makes Powerwand midline and extended dwell catheter products — and is set to add to Smith Medical’s vascular access product portfolio. The Powerwand portfolio […]
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 […]
Vascular Solutions recall of Langston dual lumen catheter is Class I
The FDA issued a notice today warning that its recall of the Vascular Solutions Langston dual lumen catheter is identified as Class I, the most serious kind of recall. Vascular Solutions, a Teleflex (NYSE:TFX) subsidiary, designed the Langston dual lumen catheter for the rapid delivery of dye into blood vessels during medical imaging tests, allowing physicians to […]
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 […]
Boston Scientific has a Class I recall of angiographic catheters
The FDA has issued a Class I designation for a recall involving the Imager II 5F angiographic catheters produced by Boston Scientific (NYSE:BSX). Marlborough, Mass.-based Boston Scientific’s catheters are designed to provide a pathway for delivering contrast agents to blood vessels including carotid arteries. According to the FDA’s recall notice, there is potential for the catheter […]
Olympus lands FDA de Novo approval for benign hyperplasia device
Olympus (TYO:7733) announced today that it received FDA de Novo classification for its iTind non-surgical device for treating benign prostatic hyperplasia (BPH). Israel-based medical device manufacturer Medi-Tate originally designed the iTind device. Olympus holds the exclusive right to distribute Medi-Tate products in the U.S. through a strategic investment. The iTind is designed as a flexible, three-strut […]