ThinkSono has received 510(k) clearance from the US Food and Drug Administration (FDA) for ThinkSono Guidance, an AI-powered software designed to help non-ultrasound-trained healthcare professionals acquire vascular ultrasound images for suspected deep vein thrombosis (DVT).
The software provides real-time guidance on probe positioning and image acquisition during lower extremity compression ultrasound examinations.
It is the first AI-powered ultrasound guidance software cleared by the FDA for suspected DVT assessment and previously received FDA Breakthrough Device Designation in February 2026.
ThinkSono Guidance connects a mobile application with compatible FDA-cleared handheld point-of-care ultrasound scanners.
Its AI technology guides operators through image capture and recording of venous compression cine-loops.
The images are then transferred to a dashboard for remote review by a qualified clinician.
The software does not interpret ultrasound images, with clinical decisions remaining under the responsibility of the reviewing clinician.
The FDA clearance is supported by multicentre clinical investigations involving 1,691 patients across 24 US and international sites, including 157 confirmed DVT cases.
A pooled analysis showed adequate diagnostic image quality in 87.1% of examinations, with 92.9% sensitivity and 97.1% prioritisation specificity.
The company is preparing for US commercial availability, with the prescription-only software operating with compatible Clarius handheld ultrasound systems.
