Roche Holding AG entered into a definitive agreement to buy Lumiradx Ltd.’s point-of-care technology platform for $350 million. The deal is part of Roche’s effort to transform its point-of-care portfolio and enable more patient-centric health care. For Lumiradx, the sale is the end of a journey to restructure and refocus the company and will result in it being delisted from Nasdaq. Read More
At first glance, the U.S. FDA’s draft guidance for evidentiary expectations for 510(k) implants seems to demand more rigor on these applications, but some in industry believe that several of these elevated requirements offer little or no commensurate benefit. Geeta Pamidimukkala of the Advanced Medical Technology Association (Advamed) said the draft would seem to require that manufacturers preemptively explain the exclusion of animal testing, a requirement she said creates more work for both industry and FDA without offering a meaningful benefit. Read More
After flying high in 2022, digital therapeutics (DTx) companies crashed to Earth in 2023 and scrambled to identify a path to profitability, or at least continued viability. Read More
Intravascular lithotripsy generally scores well for removal of calcification, but the U.K. National Institute for Health and Care Excellence (NICE) is offering only limited endorsement of this procedure for peripheral artery disease (PAD). NICE said one of the problems with the evidence is that this procedure is often conducted in conjunction with other procedures, and thus the agency will have to see more definitive evidence before an unequivocal endorsement is justified.
One of the latest state laws impacting prescription drug prices is a per se unconstitutional taking, a U.S. district judge said last week, but he refused to grant a preliminary injunction to shield manufacturers from the effects of Colorado’s new law while Teva Pharmaceuticals USA Inc.’s constitutional challenge moves through the courts. Read More
New hires and promotions in the med-tech industry, including: Early Diagnostics, Guardant Health, InspireMD, Nuview, On Target, Precipio, Synchron. Read More
Med-tech firms raising money in public or private financings, including: Bluejay Diagnostics, Cardiomech, Meihua International Medical Technologies, Radionetics. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aclarion, Adixt, Aptitude Medical, Arteraai, Cardio Diagnostics, Cardionomics, Glucotrack, Gynesonics, Sekisui, Sequana, T2 Biosystems. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anx Robotica, Sofwave. Read More
