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BioWorld - Thursday, March 12, 2026

Digital health

Home » Topics » Medical devices » Digital health
  • Digital handshake
    March 3, 2026
    By Shani Alexander

    Radnet acquires Gleamer for up to €230M

    Radnet Inc. acquired Gleamer SAS for up to €230 million (US$267 million) as it continues to expand its position across imaging and acute diagnostic care, while accelerating its move toward AI-powered automated diagnostics. Gleamer will be integrated into Radnet’s subsidiary, Deephealth Inc., strengthening its imaging portfolio, and positioning the company as the world’s largest provider of radiology clinical AI solutions.
  • Regulatory icons
    Jan. 8, 2026
    By Mark McCarty

    FDA’s new general wellness guidance is no dramatic overhaul

    The U.S. FDA’s reissuance of the 2019 guidance for general wellness products seems to carve out new territory for makers of wearables that make modest claims regarding health, but anyone who was expecting a clear break with the 2019 version of the guidance was almost certainly disappointed.
  • Crescom mediai ba 24dec25
    Dec. 24, 2025
    By Marian (YoonJee) Chu

    Crescom wins FDA clearance for bone analysis

    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.
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