ThinkSono Receives FDA Clearance for Ultrasound AI Software for Blood Clots

LONDON, UK, July 29, 2026 (Newswire.com) - ThinkSono, an ultrasound AI company, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for ThinkSono Guidance, software that provides real-time guidance to non-ultrasound-trained healthcare professionals during the acquisition of vascular ultrasound images. ThinkSono Guidance is indicated for adult patients who require a lower extremity compression ultrasound exam for the evaluation of suspected deep vein thrombosis (DVT). It is the first AI-powered ultrasound guidance software cleared by the FDA for the evaluation of suspected DVT. The device previously received FDA Breakthrough Device Designation in February 2026.

Venous thromboembolism, which includes DVT and pulmonary embolism, affects as many as 900,000 people in the United States each year and contributes to an estimated 60,000 to 100,000 deaths annually, according to the U.S. Centers for Disease Control and Prevention. Compression ultrasound is the standard imaging test for suspected DVT, but it typically depends on trained sonographers and vascular laboratories whose availability can be limited overnight, on weekends, and in rural or resource-constrained settings. This can delay assessment or lead to precautionary anticoagulation while patients wait for imaging.

ThinkSono Guidance is designed to help close that gap. The ThinkSono Guidance Mobile App connects to compatible FDA-cleared handheld point-of-care ultrasound scanners and uses an AI algorithm to guide the operator in real time through probe positioning and the recording of venous compression cine-loops, so that the anatomical sites relevant to lower extremity DVT are consistently imaged. In clinical studies, operators performed exams after 60 to 90 minutes of standardized training. Recorded cine-loops are transmitted to the ThinkSono Guidance Dashboard, where a remote qualified clinician grades image quality and assesses vein compressibility. ThinkSono Guidance does not assist in the interpretation of ultrasound images, and all clinical decisions remain under the authority of the qualified clinician.

The clearance is supported by prospective, double-blinded, multicenter clinical investigations comparing ThinkSono Guidance exams performed by non-ultrasound-trained operators against reference-standard specialist duplex ultrasound. The pivotal U.S. study enrolled 594 patients across five sites; in total, 1,691 patients were recruited across 24 U.S. and international sites, including 157 confirmed DVTs.

In a pooled analysis, exams achieved adequate diagnostic image quality in 87.1% of cases, with sensitivity of 92.9% (95% CI: 86.3-96.4%) and prioritization specificity of 97.1% (95% CI: 94.6-98.5%). Median operator scan time was 5 minutes 24 seconds, and median remote review time was 2 minutes 13 seconds. Performance was consistent across demographic subgroups, including age, sex, BMI, and race/ethnicity.

"DVT is common, dangerous, and treatable, yet whether a patient gets scanned quickly still depends on where and when they happen to present," said Fouad Al-Noor, CEO and Co-Founder of ThinkSono. "This clearance means a nurse or clinician at the bedside, guided by our software, can capture the images a specialist needs, and a qualified clinician can review them remotely within minutes. We believe this can meaningfully expand access to DVT assessment across the U.S. healthcare system."

"This technology has the potential to significantly improve patient outcomes by accelerating DVT assessment and the care that follows," said Professor Michael Blaivas, MD, MBA, FACEP, FAIUM, Chief Medical Officer of ThinkSono. "By enabling a much wider range of healthcare professionals to capture these images, we can reach patients faster and reduce delays to lifesaving treatment."

ThinkSono Guidance was granted Breakthrough Device Designation by the FDA, a program reserved for devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

ThinkSono Guidance is available by prescription only and operates with compatible FDA-cleared Clarius handheld point-of-care ultrasound scanners. ThinkSono is now preparing for U.S. commercial availability. Healthcare organizations interested in ThinkSono Guidance can contact the company at hello@thinksono.com.

Indications for Use

The ThinkSono Guidance software is intended to assist non-ultrasound-trained healthcare professionals in the acquisition of vascular ultrasound images by providing real-time guidance during probe positioning and image acquisition.

The software is compatible with point-of-care diagnostic ultrasound systems. ThinkSono Guidance does not assist in interpretation of ultrasound images. ThinkSono Guidance is indicated for adult patients who require a lower extremity compression ultrasound exam for the evaluation of suspected deep vein thrombosis (DVT).

About ThinkSono

ThinkSono is a medical AI company developing software that brings vascular ultrasound to the point of care. Founded in 2016 with teams in London, Potsdam, and the United States, ThinkSono's mission is to make the assessment of deep vein thrombosis faster and more accessible wherever patients present. For more information, visit www.thinksono.com.

Media Contact

Email: press@thinksono.com

SOURCE: ThinkSono Ltd

Source: ThinkSono Ltd