FDA Grants Clearance for UltraSight’s AI Cardiac Ultrasound

FDA Grants Clearance for UltraSight’s AI Cardiac Ultrasound
FDA Grants Clearance for UltraSight’s AI Cardiac Ultrasound


What You Should Know: 

  • UltraSight, a digital health pioneer transforming cardiac imaging through the power of artificial intelligence, announced that it has been granted FDA clearance for its AI-powered ultrasound guidance technology. 
  • The UltraSight real-time AI guidance software can assist medical professionals without sonography experience in acquiring cardiac ultrasound images at the point of care in multiple settings, allowing for more widespread detection of heart disease and providing patients easier access to cardiac monitoring.

Expanding Patient Access to Cardiac Imaging

UltraSight’s AI Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients, specifically in the acquisition of the 10 standard views of the heart. The company’s submission for FDA clearance was based on its landmark pivotal study which demonstrated that with real-time guidance of the ultrasound probe and feedback on the quality of the ultrasound image, medical professionals without prior ultrasound experience can acquire diagnostic quality images.

UltraSight’s solution will enable hospital staff to advance patient triage and treatment with increased efficiency and clinical confidence. It can also increase access to care for chronic heart disease patients by bringing cardiac ultrasound into local communities, potentially increasing patient adherence to critical treatments. 

UltraSight’s software is designed as an accessory for point of care ultrasound systems and is compatible with the Philips Lumify Ultrasound System. When paired with a compatible device, UltraSight’s underlying AI neural network predicts the position of the ultrasound probe relative to the heart, based on the ultrasound video stream, and guides the user on maneuvering the probe to capture diagnostic quality cardiac images.



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