fda-cleared

VideaHealth (VideaAI) is an FDA-cleared dental artificial intelligence platform that analyzes dental radiographs to detect clinical findings such as caries, bone loss, calculus, and periapical lesions, and to surface aligner and implant treatment opportunities.

Icardio.AI (iCardio.ai) builds artificial-intelligence software that automates the interpretation of cardiac ultrasound (echocardiography). Its FDA 510(k)-cleared products include EchoMeasure, which identifies cardiac phases and automatically measures anatomical structures to produce comprehensive echo reports, and CardioVision, which…

iSono Health is a Sunnyvale, California medical device company behind ATUSA, described as the first AI-driven portable and automated 3D breast ultrasound scanner. ATUSA performs fully automated whole-breast imaging in about two minutes per breast without a trained sonographer, pairing a 3D ultrasound scanner and wearable accessory with a Windows…