AI-Enabled Device Cleared to Detect Diminished Lung Function

The FDA has granted 510(k) clearance to Butterfly Network’s Auto B-line Counter to evaluate ultrasound scans of adults with suspected diminished lung function. 

The AI-enabled device identifies the bright, vertical B-lines from a six-second ultrasound scan and quantifies them. The B-lines indicate wetness in the lungs.

Detectable conditions include congestive heart failure, chronic obstructive pulmonary disease, pneumonia and COVID-19, the company said.

Burlington, Mass.-based Butterfly Network expects to launch the product in the U.S. in early summer.

Related Topics