Boston Scientific Corp. reported the latest setback in its transcatheter aortic valve replacement (TAVR) aspirations with the news that it is officially discontinuing worldwide sales of its Acurate neo2 and Acurate Prime systems Read More
Shockwave Medical Inc. is confident that its intravascular lithotripsy (IVL) system can continue to dominate the market for calcium modification even as other technologies emerge, chief medical officer Nick West told BioWorld. Read More
The doctrine of inherent disclosure is not one of the more common methods for invalidating patent claims, but this doctrine led the U.S. Court of Appeals for the Federal Circuit to declare that several claims found in a patent held by Carl Zeiss X-Ray Microscopy Inc. are invalid. Read More
EBR Systems Inc. raised AU$55.9 million (US$36 million) to commercialize its Wise cardiac resynchronization therapy system following U.S. FDA approval in April of the wireless, endocardial pacing system to stimulate the heart’s left ventricle. Read More
The U.S. FDA issued general correspondence letters to two device testing labs located in China. This is the latest in a series of moves by the agency to crack down on falsified or otherwise invalid device testing data. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Antylia Scientific, 23andMe, BD, Cardiosense, Smith+Nephew. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anx Robotica, Distalmotion, Empatia, Hyperfine, Olympus. Read More
