Lex Diagnostics Ltd. has submitted dual applications to the U.S. FDA seeking 510(k) clearance and CLIA waiver status for its Velo system, an ultra-fast point-of-care molecular diagnostics platform. The move comes after the recent news from Quidelortho Corp. that it intends to acquire Lex for $100 million following U.S. regulatory approval of the technology.

The European Commission is seeking feedback from stakeholders on the oversight of high-risk AI products, one objective of which is to develop a series of guidelines for classification of high-risk AI systems – a consideration of great interest to med-tech firms doing business in the EU.

The U.S. FDA posted notice of six class I device recalls between June 3 and June 5, 2025, four of which are for corrections.

The U.S. FDA’s Center for Devices and Radiological Health is recovering from a guidance drought that spanned several months in the first part of calendar year 2025, starting with a guidance on the Q-sub process.

The U.S. FDA reported the launch of its in-house generative AI (GenAI) tool, dubbed Elsa, for a variety of purposes. FDA commissioner Marty Makary assuaged industry’s privacy concerns by promising that the algorithm does not train on data submitted by makers of devices and pharmaceuticals.

The U.S. FDA’s decision to grant breakthrough device designation for Bivacor Inc.’s titanium total artificial heart (TAH) sent real hearts aflutter at the Huntington, Calif.-based company’s headquarters. While the designation supports use of the TAH as a bridge to transplant for adults with biventricular or univentricular heart failure for whom current options are insufficient or unsuitable, Bivacor hopes its device will eventually serve as a long-term heart replacement.

The Trump administration released its budget proposal for fiscal year 2026, which would chop roughly 40% from the NIH budget over the current fiscal year — a proposal that might not find much support on Capitol Hill.

The U.S. FDA declined to appeal the outcome of a lawsuit eviscerating the agency’s final rule for regulation of lab-developed tests despite a 60-day window to do so.

The U.S. FDA granted 510(k) clearance to Distalmotion SA's Dexter, its surgical robotic system, for use in cholecystectomy in adults. The greenlight from the regulatory body is the second nod Dexter has received following de novo clearance granted in 2024 for use in inguinal hernia repair.

The U.S. FDA’s device guidance drought ended with the issuance of one draft and one final guidance, the latter of which deals with the Q-sub program for early interaction with sponsors of device applications. Per a request by industry, the agency indicated it is amenable to including FDA policy staff during these meetings, which may help to avoid surprises in premarket applications.