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.
![Examples of ultrasound findings and techniques. (A) Images in a 39-year-old male patient with a mass in the left thigh. The mass is heterogeneous on the B-mode US image (compared with the patient in D) and showed increased microvascularity (superb microvascular imaging [SMI]) and shear-wave elastography (SWE) values. Undifferentiated pleomorphic sarcoma was diagnosed at biopsy (with pleomorphic rhabdomyosarcoma in surgical specimen). (B) Images in an 18-year-old male patient with a mass in the left leg. The mass is hypoechoic on the B-mode image, with no other findings suggestive of malignancy. The lesion is in contact with the cortex of the tibia, which is slightly irregular. CT revealed a doubtful anteromedial tibial erosion. The microvascular study demonstrated high vascularization, suggestive of malignancy. Periosteal Ewing sarcoma was diagnosed with both histologic and immunohistochemical confirmation. (C) Images in a 69-year-old female patient with a lump growing on the outside of the left leg. Multiple SWE examinations were performed (please note the high values obtained in the measurements, whereas the color map highlights the stiffness relative to adjacent tissues). SMI showed areas of increased vascularization to target for sampling. Undifferentiated spindle cell sarcoma was diagnosed at biopsy, with residual leiomyosarcoma in the surgical specimen after neoadjuvant therapy. (D) Images in a 56-year-old female patient with a mass in the right thigh. The mass is heterogeneous at both B-mode ultrasound (similar to patient A) and MRI (coronal T2-weighted spectral attenuated inversion recovery [SPAIR]; T1-weighted pre-contrast and postcontrast imaging), which even shows uptake after the administration of paramagnetic contrast material, which is traditionally suggestive of malignancy. Low values at SMI and elastography are suggestive of benignity. Spindle cell lipoma was diagnosed at biopsy, with atypical spindle cell lipomatous tumor in the surgical specimen.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/08/images-radiol250278fig2.APCFLSvX6p.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
