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.
Acryl Inc. debuted on South Korea’s Kosdaq Dec. 16, raising ₩42.12 billion ($28.5 million) in an IPO. Shares (KOSDAQ:0007C0) closed at ₩67,000 on the first day, up 243.5% from its offering price, before closing 30% down on Dec. 17 at ₩47,500. Seoul, South Korea-based Acryl sold 2.16 million shares priced at ₩19,500 each. Notably, Acryl won South Korea Ministry of Food and Drug Safety approval of Acryl-D01 software in December 2024, making it the country’s first AI-based digital therapeutic solution for depression screening and diagnosis. The generative AI-based medical software is cleared to analyze patient interviews and medical records and provide a probability score for clinical depression.
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%.