Caption Health has secured authorisation from the US Food and Drug Administration (FDA) to market its cardiac ultrasound software.

The software, Caption Guidance, enables medical professionals to acquire cardiac ultrasound images. It leverages artificial intelligence (AI) to offer real-time guidance and diagnostic quality assessment of images to the healthcare providers.

FDA approved the software through De Novo pathway after reviewing performance testing and data from a multi-centre prospective clinical trial.

Now indicated for use in ultrasound heart examination, Caption Guidance is effective in procuring standard views of the heart from different angles, used to diagnose various cardiac conditions.

FDA Office of In Vitro Diagnostics and Radiological Health deputy director Robert Ochs said: “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.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Initially, deployed in acute point-of-care settings such as emergency and anesthesiology departments and critical care units, the software’s usage will soon be expanded to other departments.

Caption Health co-founder and president Charles Cadieu said: “We founded Caption Health to tackle head-on some of the most challenging, intractable problems in medicine.

“This FDA authorisation confirms our unique ability to couple breakthrough technology with robust clinical validation.”