En Carta Diagnostics SA's EC Pocket Lyme received FDA breakthrough device designation for its rapid, molecular diagnostic test for the early detection of Borrelia bacteria, which causes Lyme disease. The designation marks a pivotal step for the French startup as it will enable closer interaction with the agency, accelerating its route to market, and getting it to patients sooner.

A Jan. 28 report on Medicare spending on lab tests indicated that spending on many types of tests flattened between 2022 and 2024, but spending on genetic tests rose 20% between 2023 and 2024 to $3.6 billion. While the report does not specifically call out fraud as a driver of spending, the U.S. Department of Justice posted a Jan. 26 press release identifying a case of Medicare gene testing fraud that amounted to $52 million, just one of several recent examples of this kind of fraud.

Medtronic plc acted on the increase in M&A and expansion of its investment ecosystem touted at the J.P. Morgan Healthcare Conference earlier this month with a $90 million infusion into Brisbane, Australia-based Anteris Technologies Global Corp. The investment had been contingent on a public offering of stock by Anteris, which it completed on Jan. 22. Together, the new funds for the biomimetic heart valve company totaled $320 million.

Samantree Medical SA is the latest med-tech company to secure financing from the European Investment Bank, highlighting the bank’s commitment to supporting key medical technologies across the continent. The company received a €20 million (US$23.95 million) loan which will go towards accelerating the development and commercialization of its Histolog Scanner, which allows surgeons and pathologists to visualize large, fresh tissue samples in real-time with high resolution and accuracy.