AI-based Ultrasound Echo Imaging Software Receives FDA Marketing Authorization

The US Food and Drug Administration (FDA) has authorized the marketing of a software that uses artificial intelligence (AI) to assist medical professionals in the acquisition of cardiac ultrasound images. The software, Caption Guidance from Caption Health (Brisbane, CA, USA), a medical AI company, uses AI to empower medical professionals without specialized training to perform cardiac ultrasound.

Caption Health uses technology to emulate the expertise of highly trained medical experts and put that ability into the hands of every care providers. It aims to move specialty diagnostics and decision making to the point-of-care for every patient exam. The company is developing AI software that empowers healthcare providers with new capabilities to acquire and interpret ultrasound exams.

The company’s Caption Guidance software uses AI to provide real-time guidance and diagnostic quality assessment of images, empowering healthcare providers—even those without prior ultrasound experience—with the ability to capture diagnostic quality images. Caption Guidance was authorized by the FDA via the De Novo pathway, a regulatory pathway reserved for novel technologies, making it the first medical software authorized by the FDA that provides real-time AI guidance for medical imaging acquisition. Caption Guidance is equipped with numerous features that together act as a co-pilot for clinicians when 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.

The marketing authorization was granted after the FDA reviewed extensive performance testing, including data from a pivotal multi-center prospective clinical trial conducted by Northwestern Medicine and Minneapolis Heart Institute at Allina Health, evaluating the use of Caption Guidance by registered nurses (RNs) with no prior ultrasound experience. Caption Guidance successfully met its primary endpoints, meeting the pre-specified criteria for study success. In the study, eight RNs with no prior ultrasound experience used Caption Guidance to perform ultrasound exams on 240 patients, following a short training course. Patients were stratified to include a wide range of body-mass index and cardiac pathologies. The RNs acquired limited echo exams of 10 views each. Each exam was assessed by a panel of five expert cardiologists to determine if the exam was of sufficient quality to make a set of specific qualitative visual assessments. Caption Guidance successfully met all four primary endpoints, meeting the pre-specified criteria for study success by acquiring images of sufficient quality for specific clinical assessments. In 2018, the FDA had granted Breakthrough Device designation to Caption Guidance.

In addition to Caption Guidance, Caption Health's full software suite includes automated interpretation and quality assessment capabilities, to assist clinicians throughout their workflow. Caption Guidance software can be integrated onto compatible ultrasound devices. It will be paired with Caption Health's automated ejection fraction interpretation capability and will be offered to the market as Caption AI. Caption Guidance will initially be deployed in acute point-of-care settings, including emergency and anesthesiology departments and critical care units, with plans to expand to additional departments.

"No patient should have to forgo a potentially life-saving cardiac ultrasound," said 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."

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