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The U.S. FDA’s newest draft guidance for dealing with medical product misinformation might seem to signal a cooperative attitude toward misinformation on the agency’s part, but regulatory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Kracov told BioWorld that the disincentives for doing so might still outweigh the incentives despite the reworked draft guidance.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

The end of the year will be the end of an era at the FDA, as Bob Temple shuts his door at CDER for the last time Dec. 31. After more than half a century at the FDA’s drug center, Temple has become the backbone of CDER’s new drug program, providing expertise and stability as other personnel have come and gone.

With no time to spare, the U.S. Congress is coming together on a continuing resolution (CR) to keep the federal government running beyond Dec. 20. Intended to fund the government at current levels through March 14, the CR itself is temporary. But of the 1,500-plus pages in the package House leadership released late Dec. 17, only about 100 pages pertain to the actual CR. More than a third of the package is devoted to the health-care sector.