US-based medical technology firm Caption Health has received the US Food and Drug Administration (FDA) marketing approval of its Caption Guidance for the acquisition of cardiac ultrasound images.

Caption Guidance is the first AI-guided image acquisition system that deploys artificial intelligence (AI) to offer real-time guidance, assessment of quality in diagnostic images.

The technology is said to enable healthcare providers, those with no previous ultrasound experience, to capture quality diagnostic images. Helping clinicians obtain ultrasound image acquisition capability would benefit more patients and saves cost and time, said the company.

Caption Health chief executive officer Andy Page said: “No patient should have to forgo a potentially life-saving cardiac ultrasound. Through the power of artificial intelligence, Caption Guidance will provide patients with unprecedented access to ultrasound when and where they need it most.”

Caption Guidance trial was conducted by RNs with no prior ultrasound experience

Caption Guidance is planned to be deployed initially in areas needing acute care, including emergency and anaesthesiology departments and critical care units, and will be expanded to other departments.

Setting up ultrasound in the acute care environments would facilitate triaging, monitoring, and assessing patients with chest pain, shortness of breath, cardiac arrest, and many other conditions, along with the detection of heart diseases.

Caption Health said that the FDA’s marketing approval was based on the thorough review of performance testing, including data from a clinical trial of Caption Guidance, conducted by Northwestern Medicine and Minneapolis Heart Institute at Allina Health.

The clinical trial was conducted by registered nurses (RNs) who have no previous ultrasound experience, on 240 patients, after undergoing a brief training course.

The company said that its ultrasound technology has reached all four primary endpoints, along with the pre-specified criteria for study success by acquiring quality images for specific clinical assessments.

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 authorization confirms our unique ability to couple breakthrough technology with robust clinical validation. And we’re just getting started.”