Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alife Health, Ambry Genetics, Biocardia, Biovica, Capital Digestive Care, Setpoint Medical, Stemcardia, Theromics.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Dariohealth, Inari Medical, Mainstay Medical, Nanox.AI, Novasight, Paragonix.
The news about how the U.S. False Claims Act (FCA) is adjudicated in the courts is typically dismal, but the U.S. Court of Appeals for the Ninth Circuit recently provided an exception.
Japanese researchers from Chiba University are spearheading new research into Peace of Mind Co. Ltd.’s portable Angel Touch device (AT-04), approved for neurological disorders, to treat endometriosis-related pain.
The European Parliament (EP) has passed the Artificial Intelligence Act (AI Act), bringing the legislation one step closer to full passage into law, with passage by the European Council the only remaining hurdle.
Advanced Medical Solutions Group plc (AMS) signed an agreement to buy Peters Surgical SAS for up to €141.4 million (US$154.6 million). The move by AMS for the tissue repair and skin closure manufacturer is part of its strategy to buy assets which will strengthen its product portfolio and broaden its global reach.
Another med-tech acquisition was wiped off the charts after Japan’s Olympus Corp. rescinded the acquisition of South Korean medical device firm Taewoong Medical Co. Ltd. on March 7, after finding “data integrity issues” related to Taewoong’s products.
The Cardiovascular Research Technologies 2024 conference in Washington this week demonstrated continued positive outcomes for patients who underwent transcatheter aortic valve replacement with devices made by Abbott Laboratories, Edwards Lifesciences Corp. or Medtronic plc.
Regulatory harmonization and reliance are the orders of the day at this year’s meeting of the International Medical Device Regulators Forum (IMDRF), but that does not mean individual regulators are waiting for IMDRF to act on their own imperatives.