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.

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.

Alamar Biosciences Inc.’s substantially oversubscribed series C pushed the company’s total funds raised to $250 million. The company closed the first $100 million on Feb. 26 and expects to close an additional $28 million within 30 days. The target for the series C was $100 million. The funds will be used to drive market adoption of its Argo HT system and nucleic acid linked immune-sandwich assay sequencing (NULISAseq) inflammation panel 250 for deep profiling of immune response.

In recent years, the U.S. Congress has come to rely unduly on continuing budget resolutions to fund government operations, and fiscal year 2024 is no exception. The current continuing resolution (CR) for the FDA budget is set to expire March 1, but there is concern that Congress will resort yet again to a CR to cover the balance of fiscal 2024, a predicament which suggests that the FDA’s appropriations may be flat relative to fiscal year 2023.

The U.S. FDA granted Virtual Incision Corp. de novo marketing authorization for its miniaturized in vivo robotic assistant for use in colectomy procedures in adults. The two-pound device offers portability and quick setup, eliminating the need for specialized operating rooms or arrangements to accommodate robotics.

The U.S. FDA issued an update to a previous advisory to doctors regarding the use of electromyogram endotracheal tubes made by Dublin-based Medtronic plc., but there is still some noise in the agency’s communications regarding this matter.

Zimmer Biomet Holdings Inc.’s Rosa robotics surgical assistant snapped up its fourth application with the U.S. FDA’s 510(k) clearance for use in shoulder replacement surgery. Over the past five years, the system has built a portfolio that includes partial and total knee replacement and total hip replacement.

Instead of inter partes review (IPR) being a streamlined alternative to costly patent litigation as intended, a precedential decision by the U.S. Circuit Court of Appeals for the Federal Circuit could make appeals of IPR decisions, regardless of their merits, another way to delay competition.