Retractable Technologies this week announced that it has reduced its workforce by 16% due to the completion of its facility expansion efforts — and the completion of U.S. government orders related to COVID-19 vaccines. The staff reduction will affect the Little Elm, Texas-based company’s production, operations and logistics departments. … [Read more...] about Retractable Technologies downsizes workforce
Catheters
Teleflex launches Arrow Pressure Injectable Midline catheter in EMEA region
Teleflex today announced that it has launched its Arrow Pressure Injectable Midline catheter in Europe, the Middle East and Africa regions. Wayne, Pennsylvania-based Teleflex designed Arrow to help clinicians overcome catheter identification confusion. The new, 20 cm Arrow Pressure Injectable Midline is brightly colored with yellow hubs and … [Read more...] about Teleflex launches Arrow Pressure Injectable Midline catheter in EMEA region
What is pulsed-field ablation? Here’s what you need to know
Top experts at Boston Scientific, Medtronic and Acutus Medical shared insights about pulsed-field ablation’s potential at DeviceTalks Boston. Pulsed-field ablation is a non-thermal method for cardiac ablation that has the potential to positively disrupt the way atrial fibrillation is treated. PFA’s roots go back to the dc ablation tech of the … [Read more...] about What is pulsed-field ablation? Here’s what you need to know
Getinge’s Atrium Medical has a Class I recall over covered stents
The FDA today determined that Atrium Medical's recall of some of its iCast covered stents is Class I, the most serious kind. Hudson, N.H.–based Atrium Medical — a subsidiary of Swedish medtech giant Getinge — is recalling certain iCast covered stent systems due to complaints of separation of the balloon or catheter hub from the delivery system … [Read more...] about Getinge’s Atrium Medical has a Class I recall over covered stents
Cardio Flow’s FreedomFlow guidewire wins FDA clearance
Cardio Flow this week won FDA 510(k) clearance for its FreedomFlow peripheral guidewire and announced the first commercial case using the device in the U.S. St. Paul, Minnesota–based Cardio Flow designed FreedomFlow to provide exceptional support for diagnostic and therapeutic devices in treating plaque blockages in arteries above and below the … [Read more...] about Cardio Flow’s FreedomFlow guidewire wins FDA clearance
Biomerics opens first European research & development facility
Biomerics this week announced it opened a 2,000 sq. ft research and development facility in Galway, Ireland. The new Balloons and Balloons Catheters Center of Excellence will be the first facility in Europe and the second facility outside of the U.S. It will act as an extension to its Athens, Texas operations and will be dedicated to the … [Read more...] about Biomerics opens first European research & development facility
FDA approves Medtronic’s In.Pact 018 drug-coated balloon catheter
Medtronic (NYSE:MDT) announced that it received FDA approval for its In.Pact 018 paclitaxel-coated balloon catheter. Fridley, Minnesota–based Medtronic's In.Pact 018 paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter, a drug-coated balloon product, received an indication for the interventional treatment of peripheral … [Read more...] about FDA approves Medtronic’s In.Pact 018 drug-coated balloon catheter
Abbott imaging catheter recall flagged as Class I by FDA
The FDA has identified the Abbott (NYSE:ABT) recall of its Dragonfly OpStar Imaging Catheter as a Class I recall. That's the most serious level of a medical device recall, carrying the risk of serious injury or death. Five incidents, one injury and zero deaths were reported when Abbott initiated the recall on April 11. The recall affects … [Read more...] about Abbott imaging catheter recall flagged as Class I by FDA
FDA approves Medtronic’s Onyx Frontier drug-eluting coronary stent
Medtronic (NYSE:MDT) announced today that it received FDA approval for its Onyx Frontier drug-eluting stent (DES). Onyx Frontier, the latest iteration of Medtronic’s Resolute DES family, was designed to leverage the same stent platform as Resolute with an enhanced delivery system for improving deliverability and increasing acute performance, … [Read more...] about FDA approves Medtronic’s Onyx Frontier drug-eluting coronary stent
Abbott announces availability of Xience Skypoint drug-eluting stent in extended sizes
Abbott (NYSE:ABT) announced today that its Xience Skypoint drug-eluting stent platform is now available globally. Xience Skypoint has received FDA approval, CE mark and PMDA approval in Japan for the broadest expansion with the availability of extended sizes of 4.5 mm and 5 mm offerings. Get the full story at our sister site, Drug Delivery … [Read more...] about Abbott announces availability of Xience Skypoint drug-eluting stent in extended sizes