Butterfly Network Inc received 510(k) clearance from the US Food and Drug Administration for an artificial intelligence (AI)-enabled Auto B-line Counter that allows healthcare professionals to evaluate adults with suspected diminished lung function.

The Auto B-line Counter leverages deep learning technology to produce a B-line count from a six-second ultrasound clip, according to a press release by Butterfly. B-lines on an ultrasound scan appear as bright, vertical lines that indicate wetness in the lungs and are associated with pulmonary air-space disease, such as congestive heart failure, chronic obstructive pulmonary disease, pneumonia, and COVID-19.

“Our goal at Butterfly is to give healthcare practitioners, and eventually consumers, a real-time, full-color, annotated window into the human body. Applying AI to make ultrasound easier to use is core to Butterfly and will enable powerful ultrasound to be in the palm of more clinicians’ hands across specialties to monitor, assess, and prescribe treatments in a more informed way,” says Jonathan Rothberg, PhD, Butterfly Network founder and interim CEO, in a press release. “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.”

Butterfly’s Auto B-line Counter algorithm utilizes the instant percent counting method that assigns numbers to confluent B-lines by the percentage of rib space occupied in addition to counting discrete B-lines, a technique that has been found to be more reliable than incumbent individual line counting methods. With it, trained providers can place the probe and receive a reliable number count on their screen, according to a press release by Butterfly.

To develop and train its AI algorithms, Butterfly utilizes its secure Butterfly Cloud to access over 3.5 million de-identified ultrasound cines. These data inputs come from hundreds of sites across all 50 states in the US, offering potential for a broad and diverse range of age, gender, body mass index, ethnicity, and race. 

The company anticipates the AI-enabled Auto B-line Counter will launch in early summer in the US.

Photo caption: A clinician uses the Butterfly iQ+ device and system on which the AI tool will be launched.

Photo credit: Butterfly Network