Johnson & Johnson subsumed five of its medical technology business under the Johnson & Johnson Medtech name. Ethicon, Depuy Synthes, Biosense Webster, Abiomed and Cerenovus no longer exist as independent entities, but J&J announced no changes in the product lineup. Read More
Brightflow SAS raised €16.5 million (US$18 million) in a series A financing round that will go towards developing its right ventricular mechanical circulatory support system. The company is working towards bringing the first long-term fully percutaneous implantable pump for right-sided heart failure to the market, Sophie Humbert, CEO at Brightflow, told BioWorld. Read More
The U.S. FDA’s final guidance for device remanufacturing was the result of a nearly decade-long policy examination, and the agency’s Sept. 10 webinar highlighted a few key questions. The FDA’s Angela Krueger said the agency “always encourages transparency” on the part of manufacturers to ensure device safety and performance but said the FDA does not endorse disclosure of trade secrets in providing information on device servicing. Read More
With an eye on shutting down national security threats and securing American innovation, the U.S. House overwhelmingly passed the Biosecure Act Sept. 9 with a vote of 306-81. The next stop on the bill’s path to enactment is a Senate vote and, if it gets that, then on to the president’s desk. Read More
The U.S. FDA posted a series of de novo decisions Sept. 9, including a digital diagnostic for chronic kidney disease progression by Renalytix AI Inc., of New York, and a digital therapy device for management of fibromyalgia symptoms by Swing Therapeutics Inc., of San Francisco. Read More
New hires and promotions in the med-tech industry, including: Baxter, Cognoa, Enovis, Healthtrack, Heartbeam, Ionopticks, Lifera Omics, Sphere Fluidics. Read More
Med-tech firms raising money in public or private financings, including: Billiontoone, Discure Technologies, Ionopticks, Perimeter Medical Imaging AI, Viome. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Autonomix, Fapon, Klick, Lumendi, Reveal. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Appliedvr, BD, Bearpac, Europa Biosite, Genomadix, Genomoncology, Guardant, Labcorp, Luminultra, Micronbrane, Precipio, Sensome, Serac Healthcare, Xcellbio. Read More
