AngioDynamics (NSDQ:ANGO) announced that it received FDA 510(k) clearance and CE Mark approval for its SmartPort+ implantable port product. SmartPort+ is an implantable, subcutaneous port for those who require long-term access to the central venous system for blood specimen withdrawal and administration of fluids, according to a news … [Read more...] about AngioDynamics lands 510(k) for ‘smart’ implantable port
Boston Scientific launches DirectSense technology
Boston Scientific (NYSE:BSX) announced today that it launched its DirectSense for monitoring the effect of radiofrequency (RF) energy during cardiac ablation procedures. Marlborough, Mass.-based Boston Scientific’s DirectSense is available on the Rhythmia HDx mapping system that won FDA approval in April. Rhythmia HDx monitors changes in local … [Read more...] about Boston Scientific launches DirectSense technology
Acutus Medical, Biotronik ink deal
Acutus Medical and Biotronik have announced that they will collaborate on electrophysiology, mapping, ablation and accessory products across certain markets. Under the agreement, Acutus expects to market a range of Biotronik EP ablation catheters and diagnostic/accessory products under a private label to most international markets. The companies … [Read more...] about Acutus Medical, Biotronik ink deal
Ra Medical threatened with stock exchange delisting
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 … [Read more...] about Ra Medical threatened with stock exchange delisting
FDA labels Applied Medical catheter recall as Class I
The FDA announced yesterday 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 … [Read more...] about FDA labels Applied Medical catheter recall as Class I
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, … [Read more...] about Vascular Solutions recall of Langston dual lumen catheter is Class I
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 … [Read more...] about Cagent Vascular wins FDA clearance for balloon catheter
Could these DIY ventilators stop coronavirus from killing people?
Amid the global crisis caused by the coronavirus pandemic, hospitals and healthcare facilities are reporting shortages of vital equipment that not only keeps the patients safe, but the staffers, too. One important device for which demand has ramped up is ventilators for patients who need assistance with their breathing due to the respiratory … [Read more...] about Could these DIY ventilators stop coronavirus from killing people?
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. Get the full story at our sister … [Read more...] about Boston Scientific has a Class I recall of angiographic catheters
LeMaitre Vascular recall of embolectomy catheters is Class I
The FDA identified the recall of LeMaitre Vascular (NSDQ:LMAT) Over the Wire embolectomy catheters for a failure to deflate as a Class I recall. Burlington, Mass.–based LeMaitre Vascular's Over the Wire embolectomy catheter is indicated for use in the surgical removal of blood clots that are lodged in a blood vessel (emboli) and blood clots that … [Read more...] about LeMaitre Vascular recall of embolectomy catheters is Class I
