FDA authorizes AI-guided cardiac ultrasound software: Page 2 of 2

February 10, 2020 //By Rich Pell
FDA authorizes AI-guided cardiac ultrasound software
Medical AI software company Caption Health (Brisbane, CA) has announced that the U.S. Food and Drug Administration (FDA) has authorized marketing of its software that assists medical professionals in the acquisition of cardiac ultrasound images.

Caption Guidance will initially be deployed in acute point-of-care settings that serve a high volume of patients, including emergency and anesthesiology departments and critical care units, with plans to expand to additional departments. In these environments, ultrasound can be used to triage, monitor, and assess patients who have chest pain, shortness of breath, cardiac arrest, and many other conditions, as well as for the detection of heart disease.

Caption Guidance was granted Breakthrough Device designation by the FDA in 2018. To qualify for such designation, a device must provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition, and meet additional criteria including being a breakthrough technology with no approved alternatives and offers significant advantages over existing alternatives.

Caption Health

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