FDA authorizes AI-guided cardiac ultrasound software
The company’s Caption Guidance software uses artificial intelligence (AI) to provide real-time guidance and diagnostic quality assessment of cardiac ultrasound images, enabling healthcare providers — even those without prior ultrasound experience — with the ability to capture diagnostic quality images. The FDA authorization, says the company, marks the first for an AI-guided image acquisition system.
More clinicians with ultrasound image acquisition capability, says the company, will bring the benefits of ultrasound to more patients, help standardize the quality of care, and help institutions realize valuable cost and time savings.
“No patient should have to forgo a potentially life-saving cardiac ultrasound,” says Andy Page, chief executive officer of Caption Health. “Through the power of artificial intelligence, Caption Guidance will provide patients with unprecedented access to ultrasound when and where they need it most.”
While ultrasound is a safe, non-invasive, and powerful diagnostic tool, performing ultrasound is challenging and requires specialized training to master, which prevents its adoption and can compromise quality and care, says the company. The Caption Guidance system is equipped with numerous features that together act as a “co-pilot” for clinicians performing an ultrasound exam. The software emulates the guidance that an expert sonographer would provide to optimize the image, including providing real-time guidance on how to manipulate the transducer, and automated feedback on diagnostic image quality.
Robert Ochs, Ph.D., deputy director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health says, “Echocardiograms are one of the most widely-used diagnostic tools in the diagnosis and treatment of heart disease. Today’s marketing authorization enables medical professionals who may not be experts in ultrasonography, such as a registered nurse in a family care clinic or others, to use this tool. This is especially important because it demonstrates the potential for artificial intelligence and machine learning technologies to increase access to safe and effective cardiac diagnostics that can be life-saving for patients.”
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.
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