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.

The Asia Pacific med-tech industry is expected to grow to $225 billion by 2030. Despite that rosy outlook, the landscape become increasingly challenging as med-tech investment saw a notable downturn since its peak in 2021, with venture financing and M&A deals decreasing by 22% and 37%, respectively, over the past two years.

The U.S. FDA’s newest draft guidance for dealing with medical product misinformation might seem to signal a cooperative attitude toward misinformation on the agency’s part, but regulatory attorney Daniel Kracov told BioWorld that the disincentives for doing so might still outweigh the incentives despite the reworked draft guidance.

The U.S. FDA posted another early advisory, this time for the Mini PCNL devices by Trokamed GmbH. The agency noted that these devices should not be used for suction and irrigation of surgical sites, a use for which the device was not cleared in the first place.

South Korea’s Ministry of Food and Drug Safety cleared Acryl Inc.’s Acryl-D01 as the country’s first AI-based digital therapeutic software solution to aid depression screening and diagnosis on Dec. 20. Approved as a class II software as a medical device, Acryl-D01 utilizes a patient’s medical records to quantify and analyze the individual’s emotional response and assess the probability of having clinical depression based on the data.

The U.S. FDA’s authority was challenged on a number of occasions over the past few decades, but the rate is likely to pick up as the U.S. Supreme Court ruled recently that the agency cannot take judicial deference for granted any longer. Chad Landmon of the D.C. office of Polsinelli told BioWorld that future litigation against the FDA may extend even to sub-regulatory guidance thanks to the outcome in the case of Loper Bright – a scenario in which industry might carve out a few significant wins in the coming year.

Merit Medical Systems Inc. received an early holiday gift this year, reporting that its Wrapsody cell-impermeable endoprosthesis has received premarket approval from the U.S. FDA and plans to begin commercialization of the device there in 2025.

A spate of year-end collaborations highlights growing enthusiasm for expanding use of automated insulin delivery devices or pumps in management of type 1 diabetes only to include many patients with type 2 diabetes. Beneficiaries include pump makers Tandem Diabetes Care Inc., Insulet Corp. and Medtronic plc as well as the leaders in the continuous glucose monitoring market, Abbott Laboratories and Dexcom Inc.

A new method to diagnose skin cancer was validated for the first time in clinical trials that show Dermr Health Solutions Pty Ltd.’s non-invasive microneedle patch collects near-equivalent genetic information compared to a skin biopsy without pain or cutting.