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.

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.

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.

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.

Promise Bio Ltd. emerged from stealth with $8.3 million in seed investment for its precision medicine platform, which addresses immune-mediated diseases. The funding will be used to accelerate the development of the company’s technology that analyzes proteins and their post-translational modifications to predict the treatment responses of patients with immune-mediated diseases.

Promise Bio Ltd. emerged from stealth with $8.3 million in seed investment for its precision medicine platform, which addresses immune-mediated diseases. The funding will be used to accelerate the development of the company’s technology that analyzes proteins and their post-translational modifications to predict the treatment responses of patients with immune-mediated diseases.

Promise Bio Ltd. emerged from stealth with $8.3 million in seed investment for its precision medicine platform, which addresses immune-mediated diseases.

The FDA’s final guidance for predetermined change control plans (PCCPs) for AI products contains a number of editorial changes, some more significant than others.

Mica AI Medical Ltd. is looking to transform the early diagnosis of breast cancer with its software which helps radiologists analyze mammograms more effectively. The company recently signed a collaboration and licensing agreement with Baptist Health South Florida in a bid to bring its technology to the U.S. market.

Movano Inc., dba Movano Health, added some clinical-grade glitz to its Evie ring with a U.S. FDA clearance for the built-in pulse oximeter. Movan’s stock shot up from an all-time low within minutes of the announcement on Dec. 2, as the clearance breathes new life into Movano’s plans to position the ring as a medical device.