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.

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 rescinded the acquisition of South Korean medical device firm Taewoong Medical Co. Ltd.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.

Epitomee Medical Ltd submitted its application to the U.S. FDA for 510k regulatory clearance for its swallowable weight loss capsule. It joins a host of companies offering solutions to the global obesity crisis.

Watertown, Mass.-based Lyndra Therapeutics Inc. is seeking patent protection for gastric residence drug delivery systems with improved shelf lives through their inclusion of a metal core.

Roche AG debuted a new continuous glucose monitor (CGM) at the Advanced Technologies & Treatments for Diabetes conference in Florence, Italy, last week, but how appealing users will find it remains unclear – as is the market opportunity given the entrenched position of Abbott Laboratories and Dexcom Inc.

This year’s annual meeting of the International Medical Device Regulators Forum (IMDRF) revolves around regulatory reliance, a notion that approaches but does not quite stray into the realm of the mutual recognition agreement.

U.S. deputy attorney general Lisa Monaco recently outlined some new programs related to federal enforcement across the economy, including some novel elements related to artificial intelligence (AI).

Several members of the U.S. Congress have inked legislation that provides taxpayer resources to help bring many types of manufacturing, including medical devices and equipment, back to the Western Hemisphere in general and, in some instances, the U.S.