MedTech News

Edwards launches Sapien 3 valve with Alterra prestent in Europe
Edwards Lifesciences (NYSE: EW)+
announced that it launched its Sapien 3 transcatheter pulmonary valve implant (TPVI) system with Alterra adaptive prestent in Europe.

Medtronic unveils novel approach to studying adaptive deep brain stim for Parkinson’s
Medtronic (NYSE: MDT)+
today announced the publication of its novel approach to studying adaptive deep brain stimulation (aDBS).

Senseonics receives FDA clearance for one-year CGM
Commercial partner Ascensia is in discussions with insulin pump manufacturers to create an automated insulin delivery system.

Biotronik earns expanded FDA nod for pacing lead, delivery catheter system
Biotronik announced today that it received FDA approval for its Selectra 3D catheter and Solia S lead for use in left bundle branch area pacing (LBBAP).

Penumbra receives CE Mark for Lightning Flash 2.0 and Lightning Bolt 7
The company says that Lightning Flash 2.0 will be the most advanced thrombectomy system on the European market to address venous and pulmonary thrombus.

J&J’s Shockwave adds enhanced catheter to U.S. IVL portfolio
Johnson & Johnson MedTech‘s Shockwave Medical today announced the full U.S. launch of its Shockwave E8 peripheral IVL catheter.

FDA clears tissue scanner from SamanTree Medical
SamanTree Medical announced today that it received FDA 510(k) clearance for its Histolog scanner for tissue imaging.

FDA Authorizes First Over-the-Counter Hearing Aid Software
SILVER SPRING, Md., Sept. 12, 2024 /PRNewswire/ — Today, the U.S. Food and Drug Administration authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature, intended to be used with compatible versions of the Apple AirPods Pro headphones. Once installed and customized to the user’s hearing needs, the Hearing Aid Feature enables compatible versions of the AirPods Pro to serve as an OTC hearing aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment.