FDA Clears Ultrasound Guidance Software on Vascular Imaging for DVT Evaluation
Utilization of the ThinkSono Guidance software app by non-ultrasound trained clinicians on point-of-care ultrasound devices reportedly facilitated diagnostic image quality in 87.1 percent of cases, according to recent research.
The Food and Drug Administration (FDA) has granted 510(k) clearance for ThinkSono Guidance, an AI-enabled software that reportedly offers real-time guidance on vascular ultrasound image acquisition for evaluation of deep vein thrombosis (DVT) in adults.
Geared to health-care clinicians who don’t have ultrasound training, the
ThinkSono said connecting the mobile app for the software to point-of-care ultrasound scanners enables clinicians to receive real-time guidance for probe positioning and acquisition of venous compression cine-loops. The recorded cine-loops are subsequently reviewed remotely by qualified clinicians, according to ThinkSono.
The company noted that recent research with the ThinkSono Guidance software revealed:
• median scan time of 5 minutes 24 seconds;
• median remote review time of 2 minutes 13 seconds;
• sufficient image quality in 87.1 percent of cases;
• a 92.9 percent sensitivity rate; and
• 97.1 percent prioritization specificity.
“This technology has the potential to significantly improve patient outcomes by accelerating DVT assessment and the care that follows," said Michael Blaivas, MD, MBA, FACEP, FAIUM, the chief medical officer of ThinkSono. "By enabling a much wider range of health-care professionals to capture these images, we can reach patients faster and reduce delays to lifesaving treatment.”
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