ThinkSono Receives FDA 510(k) Clearance for First AI-Powered DVT Ultrasound Software

FDA Clears ThinkSono’s Ultrasound AI Guidance Software to Evaluate Suspected DVT

July 29, 2026—ThinkSono announced that the company’s ThinkSono Guidance software has received FDA 510(k) clearance that provides real-time guidance to nonultrasound-trained health care professionals during the acquisition of vascular ultrasound images. The company is preparing for commercial availability in the United States. According to the company, ThinkSono Guidance is indicated for adult patients who require a lower extremity compression ul…

ThinkSono Receives FDA 510(k) Clearance for First AI-Powered DVT Ultrasound Software

What You Should Know Medical AI developer ThinkSono has secured FDA 510(k) clearance for ThinkSono Guidance, the first AI-powered ultrasound guidance software cleared in the U.S. for evaluating suspected lower-extremity deep vein thrombosis (DVT).Operating via a mobile app connected to compatible Clarius handheld point-of-care ultrasound (POCUS) scanners, the system enables non-ultrasound-trained healthcare staff to capture clinical-grade vascul…