ThinkSono has received U.S. Food and Drug Administration (FDA) 510(k) clearance for ThinkSono Guidance, AI software that can provide real-time guidance to non-ultrasound-trained healthcare professionals during vascular ultrasound image acquisition.
The software is indicated for adult patients requiring a lower extremity compression ultrasound exam to evaluate suspected deep vein thrombosis, according to the company. ThinkSono Guidance connects to compatible FDA-cleared handheld point-of-care ultrasound scanners and guides operators in real time through probe positioning and recording of venous compression cine-loops, the firm said. Recorded images are transmitted to a dashboard where a remote qualified clinician grades image quality and assesses vein compressibility; the software does not itself interpret images, the company noted.
In a pooled clinical analysis, exams that used the software achieved adequate diagnostic image quality in 87.1% of cases, with sensitivity of 92.9% and specificity of 97.1%, ThinkSono said. Median operator scan time was 5 minutes 24 seconds.
The device previously received FDA Breakthrough Device Designation in February 2026. ThinkSono is now preparing for U.S. commercial availability.
