South Korea’s Cell & Growth Factor Biotechnology Co. Ltd. (CG Bio) became the largest shareholder of Busan-based Inosys Korea after claiming a 34.7% stake in the embattled orthopedic implant med-tech firm.

Continuing its aggressive buying spree, Bruker Corp. entered into a definitive share purchase agreement with Tecfin S.à r.l. to acquire molecular diagnostics (MDx) company Elitechgroup SAS for €870 million (US$943.5 million), excluding the Elitech clinical chemistry business. The deal is expected to close in the second quarter of 2024 and will be funded with a mix of cash on hand and debt financing.

In what represents its first patenting, San Diego-based Intrigue Health Inc. seeks protection for a diagnostic kit that its inventors say will bring clinical laboratory quality testing directly into the home and to non-health care facilities. They say their invention will enable consumers to move from symptom to treatment in hours from the convenience of where they are, which will lead to better health outcomes and much happier consumers.

The U.S. Department of Justice (DOJ) has released the metrics for prosecutions under the False Claims Act (FCA) for fiscal year 2023, ringing up recoveries of nearly $2.7 billion, the 15th consecutive year in which recoveries exceeded $2 billion.

The U.S. FDA’s approach to predetermined change control plans (PCCP) for medical devices has been widely viewed through the lens of artificial intelligence software, but the potential scope of PCCP is much broader than merely evolutionary software and iterative device designs.

Woven Orthopedic Technologies LLC secured a second U.S. FDA 510(k) clearance for the use of its Ogmend implant enhancement system in spine surgery. The approval is for the large size Ogmend sleeve which is compatible with pedicle screws up to 10.5 mm and will give surgeons a tool to be able to easily secure stable fixation between the screw and bone during orthopedic surgery.