Edwards Lifesciences Corp. received some good news with the earlier-than-expected U.S. FDA approval of its Evoque tricuspid valve replacement system. The company beat out rival Abbott Laboratories for the honor of being the first transcatheter therapy to receive FDA approval. Read More
Hologic Inc.’s focus on women’s health is looking like a brilliant move as the company lands U.S. FDA clearance for its Genius digital diagnostics system with the Genius cervical artificial intelligence algorithm, making it the first digital cytology system with clearance, the company said. Read More
Royal Philips NV recently received some good news from the U.S. FDA which cleared its latest transesophageal echocardiography (TEE) ultrasound transducer, amidst ongoing efforts with the regulatory body to address problems with its sleep business. The X11-4t Mini 3D TEE transducer is 35% smaller than previous versions and is designed to provide cardiologists with high quality 3D images of the heart and its internal structure. Read More
Synchron Inc. has acquired an equity stake in German manufacturer Acquandas GmbH in a move that will strengthen the company’s innovation and supply chain for its brain-computer interface system, Synchron founder and CEO Tom Oxley said. Read More
The U.S. FDA has announced the next stage in its program to down-classify a series of in vitro diagnostics (IVDs) from class III to class II, a change that would significantly ease the premarket requirements for these test types. Much of the emphasis here is on companion diagnostic (CDx) tests, a category of products that is the focus of a separate FDA imperative, but there are those who view this down-classification regime as little more than a meager attempt to paste over a massive impending regulatory overhang. Read More
The week closed out with two IPOs on their way in. Alto Neuroscience Inc. (NASDAQ:ANRO) and Fractyl Health Inc. (NASDAQ:GUTS) both debuted on Wall Street with offerings looking to raise combined $238.6 million. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bruin Biometrics, Clincierge, Greenphire, Maxim Biomedical, Myriad Genetics, Pixium, Theryq, United Imaging. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Edwards, Hologic. Read More
