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
DuPont opens new biopharma tubing plant in South Carolina
DuPont today announced it has opened its new DuPont Liveo Healthcare manufacturing site in Cooper River, South Carolina. The site will be operated using the same quality standards as its Healthcare Industries Materials biopharmaceutical manufacturing site in Hemlock, Michigan. The South Carolina manufacturing site will add extrusion capacity … [Read more...] about DuPont opens new biopharma tubing plant in South Carolina
Zsquare’s single-use endoscope wins 2022 German Innovation Award
Zsquare's single-use endoscope technology was recently named a winner in the 2022 German Innovation Awards by the German Design Council. The German Design Council awards its German Innovation Awards annually to products and solutions that distinguish themselves by their "user-centricity and added value" compared to earlier solutions in all … [Read more...] about Zsquare’s single-use endoscope wins 2022 German Innovation Award
Iterative Scopes announces positive data in Skout AI colonoscopy algorithm clinical trial
Iterative Scopes today announced positive trial data in a study of its colorectal cancer screening algorithm, Skout. Cambridge, Massachusetts-based Iterative Scopes designed Skout as a computer-aided device (CADe) that uses artificial intelligence and computer vision technology to detect suspicious tissue and provide real-time feedback for … [Read more...] about Iterative Scopes announces positive data in Skout AI colonoscopy algorithm clinical trial
Avanos Medical recall of Cortrak 2 enteral access system is Class I
The FDA determined that Avanos Medical's recall of some of its Cortrak 2 enteral access systems is Class I, the most serious kind. Alpharetta, Georgia-based Avanos Medical is recalling certain Cortrak 2 general access systems due to reports of patient injuries and deaths following nasoenteric or nasogastric tube misplacement. The recall includes … [Read more...] about Avanos Medical recall of Cortrak 2 enteral access system is Class I
Penumbra grows sales 20% in Q1
Penumbra (NYSE:PEN) this week posted first-quarter results that beat the revenue consensus on Wall Street but missed earnings estimates. The Alameda, California-based company reported profits of $79,000, or -1¢ per share, on sales of $203.9 million for the three months ended March 31, for a sales growth of 20.5% compared with Q1 … [Read more...] about Penumbra grows sales 20% in Q1
Limaca Medical endoscopic ultrasound biopsy device wins FDA breakthrough designation
Limaca Medical today announced that its Precision GI endoscopic ultrasound biopsy device has received FDA breakthrough device designation. Israel-based Limaca Medical designed the endoscopic device to obtain tumor tissue within or adjacent to the gastrointestinal tract. Precision GI is deployed and operated through an instrument channel in the … [Read more...] about Limaca Medical endoscopic ultrasound biopsy device wins FDA breakthrough designation
Boston Scientific wins FDA clearance for Embold fibered detached coil
Boston Scientific (NYSE:BSX) this week announced it received FDA 510(k) clearance for the Embold fibered detachable coil for use in the peripheral vasculature. Marlborough, Massachusetts-based Boston Scientific designed Embold for use in a number of embolization procedures that block one or more blood vessels to obstruct or reduce blood flow. … [Read more...] about Boston Scientific wins FDA clearance for Embold fibered detached coil
