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.

Ebenbuild GmbH is hoping that its digital twin technology platform that combines AI and physics-based computational models tailored to individual patients will transform respiratory care. From drug development to optimizing mechanical ventilation in critical care, the company’s software-based solutions aim to reveal what is happening in the ‘black box’ of the lungs, helping clinicians to improve outcomes and reduce mortality.

Freenome Holdings Inc. reported it is going public via a special purpose acquisition company. The company said it expects to raise $330 million, which it plans to use for the 2026 launch of its blood-based screening tests for multiple cancers. Backed by an affiliate of Perceptive Advisors - Perceptive Capital Solutions Corp. (PCSP) – and joined by RA Capital, the arrangement includes a commitment of $240 million in equity investments plus about $90 million more held by the SPAC’s trust fund. Other notable investors, including ADAR1 Capital, Bain Capital Life Sciences, and Farallon Capital Management have signed on to participate in the deal.

One of the sessions at this year’s Food and Drug Law Institute’s enforcement conference dealt with the use of AI for FDA compliance activities, but the question of AI legislation also arose. The problem with AI legislation, said Nathan Brown of Akin Gump, is how to manage the details of any legislation, which presents enough drag that federally preemptive legislation stands a faint chance of passage anytime soon.

Brainomix Ltd. reported the publication of a prospective real-world study demonstrating that its AI imaging platform, Brainomix 360 Stroke, significantly increased rates of endovascular thrombectomy (EVT) treatment, a minimally invasive surgical procedure for patients with large vessel occlusion stroke, and reduced delays in patient triage and transfer.

Kakao Healthcare Corp. plans to secure ₩100 billion (US$68 million) through two investment deals with Cha Biomedical Group and outside investors by early next year. The transactions, expected to close by the first quarter of 2026, will make Cha the controlling shareholder of Kakao Healthcare with a 43.08% stake. Kakao Corp., the parent company, will hold 29.99%, and external investors will own 26.93%.

The European Commission posted a series of proposed legislative updates, including the AI Act, which might not come into force for the med tech industry until August 2028 under the terms of this proposal.

The Medicare Wasteful and Inappropriate Service Reduction (WISeR) proposal is designed to tamp down on waste, fraud and abuse in the Medicare program, but Jeff Wurzberg, a partner at Norton Rose Fulbright LLP, told BioWorld that the contractors developing these AI models have incentives to return non-covered determinations for services.

A team of five members of the U.S. FDA staff published a review of the use of AI in health care and concluded that while hallucinations in AI systems can be minimized, the trade-off is that efforts to minimize hallucinations tend to diminish the AI’s performance.

South Korean researchers led by Lee In-suk of Yonsei University have reported the most complete oral microbiome catalog to date, with more than 72,000 genomes. Detailed in Cell Host & Microbe on Nov. 12, 2025, the database is expected to serve as a universal platform for academia and enable “precision microbiome medicine” for the industry, Lee told BioWorld.