ThinkSono Guidance, an AI-powered software for ultrasound-guided detection of deep vein thrombosis (DVT), has received FDA 510(k) clearance for use with lower-extremity compression ultrasound examinations to evaluate suspected DVT in adults.
The software guides non-ultrasound-trained healthcare professionals in real-time through probe positioning and image acquisition, improving image quality and diagnostic consistency, but does not interpret images or make diagnoses.
ThinkSono Guidance received FDA Breakthrough Device designation in February 2026 and is now cleared (K260338, Class II) for use in the U.S., making it the first ultrasound AI software for blood clot detection to achieve both EU Class IIb CE mark and FDA clearance.
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