Receive our newsletter – data, insights and analysis delivered to you
  1. News
February 10, 2020

Caption Health’s cardiac ultrasound software gets marketing approval

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

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.”

Content from our partners
Small and simple: how medical device manufacturers select materials
Precision wire: The future of bespoke medical treatment
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success

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.”

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. The top stories of the day delivered to you every weekday. A weekly roundup of the latest news and analysis, sent every Friday. The medical device industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU