Teleflex (NYSE:TFX) this week initiated a voluntary field safety corrective action in Europe for its Arrow subsidiary’s multiple-lumen catheter. In a field safety notice dated March 16, Teleflex announced that Arrow is voluntarily recalling the catheter due to a potential sterility issue. Get the full story at our sister site, Medical Tubing & Extrusion
U.K. court bars Edwards TMVR sales, gives Abbott win in patent spat
A judge in the England issued an injunction yesterday barring Edwards Lifesciences from selling its Pascal transcatheter mitral valve repair (TMVR) device in the U.K. A different judge had previously denied Abbott’s petition for such an injunction. Yesterday, Judge Colin Birss of the High Court of England and Wales also ruled that two patents held […]
NYSE accepts Ra Medical’s compliance plan
Ra Medical Systems (NYSE:RMED) announced today that the New York Stock Exchange (NYSE) accepted its business plan to regain compliance with the NYSE continued listing standards. In December 2019, Carlsbad, Calif.-based Ra Medical Systems received a letter from the NYSE to notify the company of its non-compliance with the NYSE continued listing standards, as Ra Medical’s […]
Judge tosses most of Neurvana case against Balt execs
A Delaware chancery court judge has tossed nearly all of the claims brought by Neurvana Medical against a pair of senior executives of Balt International for reneging on a $16 million deal for Neurvana’s Titan neurovascular catheter. The story of the lawsuit, filed in January 2019, begins with Balt’s September 2016 acquisition of Blockade Medical, including […]
Cardiovalve scores FDA wins for its transcatheter tricuspid valve replacement tech
Cardiovalve (Or Yehuda, Israel) said today that U.S. FDA has granted a breakthrough device designation for its transcatheter tricuspid valve replacement system. FDA also approved an early feasibility study of the system for a tricuspid regurgitation (TR) indication. Cardiovalve touted that it is the first privately held company to have the FDA early feasability study […]
These young medtech companies raised the most money in 2019
Medical device industry insiders may very well remember 2019 as the year that IPOs came back — but another sign that the U.S. economy has left the Great Recession far behind. Among the top investment deals in the space, half involved public offerings, according to the MoneyTree report from PricewaterhouseCoopers (PwC) and CB Insights. Total investments […]
Integer expands to Israel
Integer Holdings (NYSE:ITGR) today announced it has acquired medtech manufacturer Inomec, formally establishing its presence in Israel. The Plano, Texas-based company said the acquisition will enable it to create an R&D and sales center in the region and adds important catheter design, clinical and pilot manufacturing capabilities to its portfolio. “Acquiring Inomec strengthens our research and development […]
FDA: Abbott recall of coronary dilation catheters is serious
An Abbott (NYSE:ABT) recall of certain coronary dilation catheters is Class I — the most serious type of recall, FDA said today. The recall, which Abbott originally announced Jan. 29, involves nearly 14,000 NC Trek RX coronary dilatation catheters and NC Traveler RX coronary dilatation catheters with 4.0 mm, 4.5 mm and 5.0 mm balloon diameters. […]
JenaValve raises $50m for TAVR tech
JenaValve Technology announced that it raised $50 million in equity financing as it develops and manufactures the JenaValve pericardial transcatheter aortic valve replacement (TAVR) system for treating aortic valve disease. Bain Capital Life Sciences led the funding round, while Andera Partners, Gimv, Legend Capital, NoMed Management, RMM, Valiance Life Sciences and VI Partners all participated, […]
CloudCath raises $12m for at-home dialysis monitoring software
CloudCath announced today that it completed a $12 million Series A financing round for its at-home dialysis monitoring treatment platform. San Francisco–based CloudCath’s system, which is its first product, is designed to enable remote, real-time monitoring for people undergoing at-home peritoneal dialysis to allow for earlier complication intervention. Proceeds from the funding round are also […]
Bluegrass Vascular Technologies wins de novo nod for ‘inside-out’ vascular access catheter
Bluegrass Vascular Technologies announced that it won FDA de novo clearance for its Surfacer inside-out access catheter system. The Surfacer is designed to obtain central venous access through its inside-out approach, facilitating catheter insertion to the central venous system in people with upper body venous occlusions or other conditions that limit central venous access through […]
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