Aidoc Medical Ltd.'s Care AI foundation model secured 11 new U.S. FDA-cleared indications for use in emergency department triage. Now, with 14 total cleared indications enabling comprehensive evaluation and prioritization of abdomen CTs in a single workflow, Aidoc Care can help health systems identify critical findings more quickly and mitigate delays caused by overcrowding and imaging backlogs.
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.
Radiopharm Theranostics Ltd.’s radiotracer RAD-101 met the primary endpoint in 92% of patients in the phase IIb imaging trial in brain metastases, according to interim results. To date, 11 of the 12 patients treated with RAD-101 (F18-Pivalate) achieved concordance with MRI (the primary endpoint) as assessed by PET imaging of brain metastases. The results showed significant and selective tumor uptake, and images confirm metabolic activity in brain metastases compared to equivocal MRI findings.