FastWave Medical announced today that it received a fourth utility patent to strengthen the IP foundation of its IVL platform. Minneapolis-based FastWave develops laser-based intravascular lithotripsy (IVL) technology for treating calcific artery disease. Its platform offers durable and fast energy delivery with enhanced sonic output to navigate complex arterial anatomy through a high-performing catheter. FastWave’s […]
Latest News on MassDevice
Smiths Medical issues urgent field safety notice for some Portex tracheotomy tubes
ICU Medical’s Smiths Medical this week issued an urgent field safety notice for some of its Portex Blue Line siliconized PVC tracheotomy tubes. The company issued the warning due to an issue related to the neck plate or flange of the Portex Blue Line siliconized PVC tracheotomy tubes. The failure mode can happen during use […]
CPR Therapeutics appoints first chief strategy officer
CPR Therapeutics this week announced it appointed Mike Black as its first chief strategy officer. Black has held numerous leadership roles within the medtech industry. He has over 20 years of executive management experience in the industry and has led early-stage medical device companies through commercialization and successful exit with strategic partners. Most recently, he […]
Glucotrack expands CGM tech to spinal epidural space
Glucotrack (Nasdaq:GCTK) announced today that it plans to expand its glucose monitoring technology to measure glucose in the epidural space. Rutherford, New Jersey-based Glucotrack said CGM taking readings in the spinal epidural space could integrate with existing treatments for painful diabetic neuropathy (PDN). Specifically, Glucotrack sees spinal cord stimulation (SCS) technology as a potential integration […]
FDA approves XStim spine fusion stimulator
Xstim announced today that it received premarket approval from the FDA for its Xstim spine fusion stimulator device. Irving, Texas-based Xstim designed its capacitively coupled device to emit a low-energy signal. This, in turn, promotes bone healing following spinal fusion surgery. The company plans to make the device commercially available in the second quarter of […]
Caranx performs first TAVI procedure using surgical robot
Caranx Medical today announced it completed its first robotic assisted transcatheter aortic valve implantation. The assisted heart valve implantation in an animal was successfully performed by Dr. Stéphane Lopez, Caranx CMO Dr. Eric Sejor, Caranx CTO Pierre Berthet-Rayne and the Caranx team. “This groundbreaking achievement is the result of hard teamwork. At Caranx Medical, we […]
Johnson & Johnson EPS beats The Street in Q1, ups sales guidance
Johnson & Johnson shares dipped slightly today, even as first-quarter earnings came in ahead of the consensus forecast. Shares of JNJ fell 1% to $145.16 apiece by mid-day trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — fell slightly. The New Brunswick, New Jersey-based medtech giant […]
Orthofix names Andres Cedron as chief legal officer
Orthofix today announced it appointed Andres Cedron as chief legal officer, effective immediately. Cedron was most recently VP and corporate secretary at Stryker, overseeing the company’s corporate governance, SEC compliance, mergers and acquisitions, and ESG matters. “With a broad breadth of experience in the medical device industry and legal transactions, Andres is the perfect fit […]
Olympus earns coverage win for iTind procedure
Olympus today announced positive changes to commercial payer policies covering patients who could benefit from its iTind procedure. iTind treats symptoms of lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH), or enlarged prostate. Aetna updated its Clinical Policy Bulletin 0079 for Benign Prostatic Hyperplasia to include the iTind procedure as medically necessary […]
IceCure submits final breast cancer cryoablation data to FDA
IceCure Medical (Nasdaq:ICCM) announced today that it submitted final data to the FDA requesting marketing authorization for its ProSense system. Caesarea, Israel-based IceCure designed ProSense to deliver cryoablation that treats breast cancer in a 20-40-minute outpatient procedure. It seeks FDA authorization for treating patients with early-stage T1 invasive breast cancer with cryoablation and adjuvant hormone […]
Abbott has another serious LVAD recall
The FDA today labeled Abbott’s recall of some HeartMate II and HeartMate 3 left ventricular assist systems (LVAS) as Class I, the most serious kind. Abbott issued the recall of the HeartMate II and HeartMate 3 LVAS due to an issue known as extrinsic outflow graft obstruction (EOGO). The issue happens when biological material builds […]