The U.S. FDA’s final rule for regulation of lab-developed tests was destined to be controversial at best and exceptionally susceptible to legal challenge according to more than one legal opinion. The inevitable legal challenge succeeded wildly in a decision rendered in district court in March 2025, marking one of the rare instances in which the courts thwarted FDA rulemaking and thus is easily the regulatory story of the year for 2025. Attempts to regulate AI in the U.S. and Europe also dominated the regulatory landscape.

Crescom Co. Ltd., an AI musculoskeletal imaging company, gained U.S. FDA 510(k) clearance Dec. 24 for MediAI-BA, its AI-powered pediatric and adolescent bone age analysis software. Classified as a class II medical device, MediAI-BA evaluates bone age and suggests predicted adult height based on growth plate status assessed by hand and wrist X-ray imaging. Prior clinical trial results demonstrated MediAI-BA had specialist-level accuracy, recording a mean absolute deviation (MAD) of 0.39 years.

The EU’s Medical Device Coordination Group (MDCG) posted two guidances in the waning weeks of 2025, one of which deals with postmarket surveillance for both devices and diagnostics. Another guidance deals with breakthrough devices (BtX) and diagnostics, a question that is not well described in either of the current EU regulatory frameworks.

Payers had their hands full in 2025 dealing with the raft of medical technologies that came through the globe’s regulatory review processes, although the nature of many of those challenges were conventional. On the other hand, payers struggled to keep pace with both the volume of conventional devices and the novelty of AI-driven devices in 2025, a problem that will carry over into the coming year.

Edwards Lifesciences Corp. received U.S. FDA approval for its Sapien M3 mitral valve replacement system, making it the first transcatheter therapy utilizing a transseptal approach to be indicated for treatment of mitral regurgitation (MR). The Sapien M3 transcatheter mitral valve replacement system is indicated for the treatment of patients with symptomatic moderate-to-severe or severe MR or symptomatic mitral valve dysfunction who are deemed unsuitable for surgery or TEER by a multidisciplinary heart team.

Two years after the U.S. FDA approved the first pulsed field ablation system, Abbott Laboratories finally got the regulatory nod for its Volt PFA system. Abbott follows Medtronic plc, Boston Scientific Corp., Johnson & Johnson and Kardium Inc. in receiving approval for its approval for use of its PFA device to treat atrial fibrillation.

The year 2025 will go down in med-tech history as remarkable for a number of things, but manufacturers doing business in the EU might be forgiven for thinking that it was a year for correction of self-inflicted wounds, even if those corrections won’t arrive in full form until 2026.

Two U.S. Medicare administrative contractors (MACs) have removed CPT code 6468 from their group 1 CPT codes, a move that may cut rates for implant of Inspire Medical Inc.'s flagship product, the Inspire hypoglossal nerve stimulator for treatment of obstructive sleep apnea.

The Trump administration has made known that it intends to foster rapid adoption of AI, starting with a repeal of an executive order (EO) issued by the Biden administration. Now, the White House has issued an EO that would override state AI law, a move that addresses a task that Congress to date has failed to complete.

The FDA’s final guidance for the use of real-world evidence (RWE) was touted by FDA commissioner Marty Makary as opening the door to the use of existing de-identified data in premarket device submissions, but the final guidance lends also clarifies a couple of points about when an investigational device exemption will be needed for RWE studies.