The US Food and Drug Administration (FDA) has granted 510(k) clearance to digital health company Butterfly Network’s artificial intelligence (AI) enabled lung tool.

Healthcare professionals can use the new AI-enabled Auto B-line Counter to assess adults with suspected diminished lung function.

The tool will enable them to make informed treatment decisions at the point of care.

Butterfly Network founder and interim CEO Dr Jonathan Rothberg said: “Applying AI to make ultrasound easier to use is core to Butterfly, and will enable powerful ultrasound to be in the palm of more clinician’s hands, across specialties, to monitor, assess and prescribe treatments in a more informed way.

“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.”

Leveraging deep learning technology, the tool generates a B-line count from a six-second ultrasound clip.

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Ultrasound scans indicate wetness in the lung and then display B-lines as bright, vertical lines. They are linked to pulmonary air-space diseases, such as chronic obstructive pulmonary disease, congestive heart failure, pneumonia, and Covid-19. 

The Auto B-line Counter algorithm applies an advanced instant percentage-counting method for assigning numbers to confluent B-lines by the percentage of rib space occupied.

The technology enables trained providers to simply place the ultrasound probe on the patient and receive a number count right on their screen.

Butterfly Network aims to launch the new AI-enabled lung tool in the US in early summer this year.

The company uses its Butterfly Cloud platform for the development and training of its AI algorithms. This platform provides access to more than 3.5 million de-identified ultrasound cines.