The FDA granted 510(k) clearance to Crescom’s MediAI‑BA, an AI‑powered pediatric and adolescent bone age analysis application, citing specialist‑level accuracy in prior trials. The device predicts bone age and projected adult height from hand‑wrist X‑rays and is classified as a class II medical device. Separately, Edwards Lifesciences won FDA approval for its Sapien M3 transcatheter mitral valve replacement system, the first transseptal transcatheter therapy indicated for mitral regurgitation in patients unsuitable for surgery or TEER. Together, the clearances reflect continued regulatory momentum for both AI diagnostics and complex transcatheter structural therapies.