AI-guided image acquisition system gets FDA clearance

March 25, 2020 0 By FM

The US FDA has authorized marketing of Caption Guidance software that assists medical professionals in the acquisition of cardiac ultrasound images.

The software uses artificial intelligence to provide real-time guidance and diagnostic quality assessment of images, empowering healthcare providers—even those without prior ultrasound experience—with the ability to capture diagnostic quality images. 

Caption Guidance was authorised via the De Novo pathway, a regulatory pathway reserved for novel technologies.

Caption Guidance will initially be deployed in acute point-of-care settings, including emergency and anesthesiology departments and critical care units, with plans to expand to additional departments.

Marketing authorization was granted after the FDA reviewed extensive performance testing, including data from a pivotal multi-centre prospective clinical trial conducted by Northwestern Medicine and Minneapolis Heart Institute at Allina Health.

In this study, eight RNs with no prior ultrasound experience used the software to perform ultrasound exams on 240 patients.

In 2018, the FDA granted Breakthrough Device designation to Caption Guidance. interpretation capability and will be offered to the market as Caption AI, Caption Health said.