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
LeMaitre Vascular grows sales 10% in Q1 results
Lemaitre Vascular (NSDQ:LMAT) posted first-quarter results that beat the revenue consensus on Wall Street and missed earnings estimates. The Burlington, Massachusetts-based vascular device company reported profits of $6 million, or 27¢ per share on sales of $39.6 million for the three months ended March 31, for a bottom-line gain of 1.8% on … [Read more...] about LeMaitre Vascular grows sales 10% in Q1 results
CathVision completes patient enrollment in ECGenius EP recording system clinical trial
CathVision this week announced it completed patient enrollment in the CathVision ECGenius System clinical study. The company anticipates FDA 510(k) clearance for the ECGenius System within the next two weeks, a company representative said. The clinical evaluation study is being conducted at the University of Vermont Medical Center and will … [Read more...] about CathVision completes patient enrollment in ECGenius EP recording system clinical trial
Acutus Medical sells left-heart access portfolio to Medtronic in $50M deal
Acutus Medical (NSDQ:AFIB) today announced that it has entered a definitive agreement to sell its left-heart access portfolio to Medtronic (NYSE:MDT) for $50 million. Medtronic will make an upfront cash payment to Princeton, N.J.–based Acutus Medical of $50 million upon the initial closing of the transaction, which is subject to the satisfaction … [Read more...] about Acutus Medical sells left-heart access portfolio to Medtronic in $50M deal
18 of the world’s most innovative medical technologies
Judges this week are voting for the most innovative medical technologies among the nominees for the 2022 Prix Galien International Awards. The Prix Galien International Awards highlight the most innovative technologies in the life sciences industry. The New York-based Galien Foundation presents the international award to eligible nominees that … [Read more...] about 18 of the world’s most innovative medical technologies
FDA clears Franklin Mountain Medical UltraNav transseptal catheter system
Franklin Mountain Medical this week announced its UltraNav transseptal catheter system has received FDA 510(k) clearance The Phoenix, Arizona-based company designed UltraNav for controlled access and delivery of cardiovascular catheters and guidewires into the heart chambers through a transseptal puncture. The dual-lumen catheter enables … [Read more...] about FDA clears Franklin Mountain Medical UltraNav transseptal catheter system
First patient in the world implanted with Abiomed Impella BTR heart pump
Abiomed (Nasdaq:ABMD) today announced the first patient in the world was successfully treated with its Impella Bridge-to-Recovery (BTR) as part of an early feasibility study. The first implant was performed by Dr. Duc Thinh Pham and Dr. Jane Wilcox at Northwestern Medicine Bluhm Cardiovascular Institute in Chicago. Impella BTR is a forward … [Read more...] about First patient in the world implanted with Abiomed Impella BTR heart pump
