First AI-Guided Ultrasound ECHO Software Approved for Marketing

Caption Guidance, an echocardiography software, offers real-time guidance for ultrasound image acquisition using artificial intelligence technology.

On February 7th, San Francisco-based startup Caption Health (previously known as Bay Labs), announced the marketing approval for Caption Guidance, a software that could be integrated with compatible ultrasound devices. The software acts as a “co-pilot” to assist even inexperienced medics in acquiring ultrasound images of the heart. “This FDA authorization confirms our unique ability to couple breakthrough technology with robust clinical validation. And we’re just getting started.” said Charles Cadieu, co-founder and President. With this, Caption Guidance becomes the first AI-guided medical imaging system to acquire FDA authorization.

Like a seasoned sonographer, the software provides real-time guidance to optimize an image, manipulate the transducer, and also gives automated feedback on quality. It can currently be used as an accessory with the diagnostic ultrasound system produced by Teratech Corporation. “No patient should have to forgo a potentially life-saving cardiac ultrasound,” said Andy Page, the CEO. “Through the power of artificial intelligence, Caption Guidance will provide patients with unprecedented access to ultrasound when and where they need it most.”

The FDA approval was based on the software’s performance in two independent clinical trials, of which one was conducted by Northwestern Medicine and Minneapolis Heart Institute at Allina Health. The study evaluated the software’s value in assisting 8 registered nurses who lacked expert training in sonography to capture diagnostic quality images from 240 patients. Caption Guidance was approved through the FDA’s De Novo premarket review pathway, a regulatory pathway for novel devices whose type has not previously been classified.

“Echocardiograms are one of the most widely-used diagnostic tools in the diagnosis and treatment of heart disease,” said 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. “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.”

Related Article: First AI-Designed Drug to Enter Phase I Clinical Trial

References

1. https://www.prnewswire.com/news-releases/fda-grants-caption-health-landmark-authorization-for-first-ai-guided-image-acquisition-system-301001106.html
2. https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-first-cardiac-ultrasound-software-uses-artificial-intelligence-guide-user

Author

Rajaneesh K. Gopinath