FDA greenlights AI-guided CV ultrasound acquisition system

Medical AI company Caption Health announced Feb. 7 that the FDA had authorized marketing for its Caption Guidance software.

Caption Guidance is an AI-guided medical image acquisition system, according to a release from the California-based company, which used to operate as Bay Labs. The platform leverages artificial intelligence to provide real-time guidance and “diagnostic-quality assessment of images” even for providers who aren’t well-versed in cardiac imaging; Caption Health calls it a clinician’s “co-pilot” in the imaging suite.

Caption Guidance was reportedly the first medical software authorized by the FDA to serve its purpose, and was fast-tracked to approval via the agency’s De Novo pathway. According to Caption Health, the software emulates the guidance of an expert sonographer to optimize an image and streamline its interpretation.

“No patient should have to forgo a potentially life-saving cardiac ultrasound,” CEO Andy Page said in a statement. “Through the power of artificial intelligence, Caption Guidance will provide patients with unprecedented access to ultrasound when and where they need it most.”

The software is slated to debut in acute point-of-care settings, including emergency and anesthesiology departments and critical care units, since ultrasound can be used to triage and monitor patients in such settings. It will then be rolled out to other departments.

“Point-of-care ultrasound has been demonstrated to expedite time to diagnosis, reduce the need for more costly testing and decrease complications from invasive procedures,” John Bailitz, System Point of Care Ultrasound Education Director at Northwestern Medicine, said in the release. “Caption Guidance can unlock these benefits by addressing one of the largest barriers to ultrasound adoption: the ability to acquire diagnostic-quality images quickly.”