The device industry is extraordinarily dependent on administrative activity where Medicare coverage is concerned, and this was exceptionally evident in 2024 when software and digital health coverage policies remained bogged down.

2024 was a critical year for the FDA’s Center for Devices and Radiological Health and included a smooth transition in leadership, but it was not without controversy. The agency triggered not one but two lawsuits over the final rule for regulation of lab-developed tests, a problem that promises to distract the agency throughout 2025 and potentially beyond.

The U.S. FDA’s draft guidance for reporting of deviations from clinical study protocols lends some insight as to the definition of a deviation, but the agency highlights some concerns about related compliance activities.

Artificial intelligence (AI) is no novelty for medical technology, but 2024 saw an interesting series of events in this area from across the globe. While some of these developments portend immediate regulatory clarity, some are harbingers of continued regulatory flux in 2025 and beyond.

The U.S. FDA has issued a second report in connection with device software functions, which includes surveillance data for clinical decision support (CDS) tools. While the report lists three events that qualify as adverse events, the FDA offered no information that would provide an adverse event rate for CDS products.

Sequana Medical NV received premarket approval from the U.S. FDA for its Alfapump system to treat recurrent or refractory ascites due to liver cirrhosis. Data from the Poseidon pivotal study showed the implantable device, which removes ascites from the abdomen into the bladder, can eliminate the need for therapeutic paracentesis, improving the quality of life of patients.

Device makers doing business in the U.S. have had a much more stable regulatory regime than has been true for companies in other jurisdictions, but that will shift somewhat in 2025. Brynn Stanley of Gardner Law told BioWorld that manufacturers should get busy with the U.S. FDA-mandated do-over of their quality management systems as the compliance deadline of February 2026 does not generally permit procrastination.

When every hour’s delay in treatment increases the risk of death 8%, dialing down time to diagnosis takes on acute urgency for clinicians and regulators. When the disease being treated kills 20% of the global population and 33% of hospitalized patients in the U.S., the market opportunity attracts investors. And when the technology makes breakthroughs possible that cut the time to targeted treatment from days to hours or even minutes, the number of products in development explodes, as the keen competition in sepsis diagnostics covered by BioWorld in 2024 demonstrates.

AI pulled in major financings and approvals for Asia med-techs in 2024 as Asia Pacific countries played to individual strengths to maximize AI’s applications in the health care sector. While breakaway AI technologies like OpenAI’s ChatGPT reshaped and boosted many industries, AI also drove major financings for APAC med-techs weathering a wider macroeconomic downturn, with AI-based companies accounting for five out of 11 IPOs tracked on BioWorld’s med-tech IPOs list.

As if the uncertainties surrounding an incoming administration weren’t enough, a landmark U.S. Supreme Court decision and a potential new avenue of liability for drug and device manufacturers could bring an added level of unpredictability to the sector for 2025.