The FDA granted 510(k) clearance to ThinkSono Guidance, software that steers non-sonographers through lower-extremity compression ultrasound for suspected deep vein thrombosis. The app pairs with handheld Clarius scanners, records cine-loops, and sends them to remote clinicians for review. In a pivotal U.S. study of 594 patients, exams met diagnostic image quality in 87.1% of cases, with 92.9% sensitivity versus specialist duplex. The tool does not diagnose; specialists still interpret images. Caveat: U.S. commercial rollout is still preparing, and results depend on operator training plus remote review capacity.