Biotronik announced today that the FDA approved its portfolio of Amvia Edge pacemakers and cardiac resynchronization therapy pacemaker (CRT-P). Lake Oswego, Oregon-based Biotronik designed Amvia Edge as the market’s smallest single-chamber MR conditional pacemaker. It offers a set of patient-centric solutions coupled with automated workflow efficiency. The pacemakers feature Biotronik’s proprietary MRI Guard 24/7 technology. […]
Stryker launches Ortho Q fully autonomous guidance system
Stryker announced today that it launched its Ortho Q guidance system. Kalamazoo, Michigan-based Stryker says Ortho Q is the only fully autonomous system in the industry. Surgeons can easily control the platform from the sterile field. It combines new optical tracking options through a redesigned, state-of-the-art camera. According to a news release, Ortho Q features […]
BioCardia seeks Japanese approval of heart failure cell therapy
BioCardia (Nasdaq:BCDA) announced today that it completed the submission of its CardiAMP cell therapy system to Japan’s regulatory authorities. Sunnyvale, California-based BioCardia submitted CardiAMP to Japan’s Pharmaceutical and Medical Device Agency (PMDA). It seeks approval for the indication of ischemic heart failure with reduced ejection fraction (HFrEF). It expects a formal consultation with PMDA to […]
BD is cutting 60 jobs at Ireland facility
BD announced plans to eliminate 60 positions at its manufacturing facility based in Drogheda, Ireland. A statement provided by a BD spokesperson confirmed a targeted reduction of 60 positions due to a combination of factors. These include the effects of the COVID-19 pandemic and the company’s spinoff of its diabetes business, Embecta. The company announced […]
Ra Medical announces international distribution expansion
Ra Medical Systems (NYSE:RMED) announced the undertaking of a new effort to expand its distribution outside the U.S. Last week, the company filed for CE mark approval for its LockeT device that assists in percutaneous puncture site closure. RA Medical says its expansion effort reflects its expectation of receiving CE mark during the third quarter. […]
Medtronic applauds new renal denervation guidelines in Europe
Medtronic issued a statement highlighting its excitement over new renal denervation guidelines in Europe. The European Hypertension Society (ESH) issued updated guidelines on the role of renal denervation in the hypertension care pathway. It announced the guidelines at the ESH 32nd Annual Meeting and simultaneously published them in the Journal of Hypertension. Medtronic said in […]
Abbott wins FDA nod for first dual-chamber leadless pacemaker
Abbott announced today that it received FDA approval for its Aveir dual-chamber leadless pacemaker system. The approval marks the first such nod for a dual-chamber leadless pacing system for treating abnormal or slow heart rhythms. According to Abbott, more than 80% of people who need a pacemaker require pacing in two chambers of the heart […]
Dexcom CCO Teri Lawver says new sensor is ‘first step’ to expand addressable market
Teri Lawver joined Dexcom as chief commercial officer just as the company got set for a massive commercial undertaking. The FDA cleared the company’s next-generation Dexcom G7 continuous glucose monitor (CGM) in December 2022. One month later, Lawver assumed the position of CCO. Within about a month, she was set to oversee the U.S. launch […]
Xtant Medical announces $15M private placement
Xtant Medical (NYSE:XTNT) announced today that it agreed to sell shares of its common stock in a private placement worth $15 million. Belgrade, Montana–based Xtant agreed with accredited investors to issue an aggregate of 20 million shares of common stock. Priced at 75¢ per share, the private placement totals gross proceeds of $15 million. The […]
ReWalk Robotics, Myomo to benefit from new proposed Medicare classifications
A new proposed rule from the Centers for Medicare and Medicaid Services (CMS) could benefit companies like ReWalk Robotics (Nasdaq:RWLK) and Myomo (NYSE:MYO). The proposed rule would establish a new regulatory definition of “brace.” In Myomo’s case, it aims to classify the L8701 and L8702 HCPCS codes as “brace.” Adding the definition of brace would […]
The biggest stories from the American Diabetes Association (ADA) 2023 Scientific Sessions
As it does every year, this past week, the American Diabetes Association convened its Scientific Sessions to bring together leaders in the diabetes space. At last year’s event, next-generation technologies from the big hitters took the spotlight. The 83rd iteration this past week produced a range of new studies, product updates and positive news for […]