AI-Enabled Lung Assessment Tool for Handheld Ultrasound Gets FDA Nod

The Food and Drug Administration (FDA) has granted 510(k) clearance for the Auto B-line Counter (Butterfly Network), a handheld ultrasound tool that may help accelerate assessment of suspected lung function abnormality in patients with conditions ranging from chronic obstructive pulmonary disease (COPD) to COVID-19.

In contrast to traditional manual processes for counting B-lines from lung ultrasound scans, the Auto B-line Counter utilizes deep learning technology that can provide a B-line count from a six-second ultrasound clip, according to the Butterfly Network, the manufacturer of the modality.

Incorporating an instant percent counting technique, Butterfly Network said the algorithm for the Auto B-line Counter accounts for discrete B-lines as well as confluent B-lines by the percentage of occupied rib space.

“Our AI-enabled Auto B-line Counter empowers providers to assess lung conditions faster and with more confidence ­ and in turn will aid in earlier detection, diagnosis, and treatment of cardiovascular diseases, a leading cause of death globally, taking nearly 18 million lives each year,” noted Jonathan Rothberg, Ph.D., the founder and interim chief executive officer of Butterfly Network.