The Caption Guidance software uses AI to help clinicians with the acquisition of high-diagnostic-quality cardiac ultrasound images, a widely used tool for diagnosing and treating heart disease. It not only provides real-time guidance as clinicians manipulate the ultrasound probe to capture imaging data, but also offers immediate feedback on the quality of the captured images.
The FDA granted authorization based on independent clinical trials of the software, one of which was conducted by Chicago-based Northwestern Medicine and Allina Health’s Minneapolis Heart Institute.
“Today’s marketing authorization enables medical professionals who may not be experts in ultrasonography, such as a registered nurses in a family care clinic or others, to use this tool,” Robert Ochs, PhD, deputy director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in an FDA news release. “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.”
With its FDA clearance, the Caption Guidance system will be available for integration into acute care settings such as emergency and anesthesiology departments. Caption Health has plans to further expand the software’s reach into other hospital departments.
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