Exo received FDA-clearance for AI tools and adds to handheld ultrasound system

Exo received FDA clearance for its Iris device in 2021 and expanded its capabilities in 2022. These clearances apply to handheld portable diagnostic ultrasound systems, akin to Butterfly Network's iQ, allowing healthcare providers to assess body structures and fluids in adults and children, with images viewable on smartphones.

In 2023, Exo gained additional FDA clearances for AI products, including software quantifying bladder volume and a broader AI platform detecting medical parameters in adult patients with suspected diseases.

Although the clearance is broad, Exo specified the platform's applications in its FDA submission, focusing on viewing lung and heart ultrasound images, placing landmarks, and generating reports.

Healthcare professionals can utilize AI-assisted tools to quantify ejection fraction from cardiac ultrasound images and identify lung structures and artifacts, though manual verification is recommended. Exo plans to double its FDA clearances by 2025, enhancing capabilities of its Iris handheld ultrasound system.