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.
F DA 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.
F DA 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.”
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 F DA authorisation confirms our unique ability to couple breakthrough technology with robust clinical validation.”