Butterfly Network receives FDA clearance for lung function diagnostic
Butterfly Network, a digital health company specialising handheld, whole-body ultrasound, has received 510(k) clearance for an AI-enabled Auto B-line Counter that may simplify how healthcare professionals evaluate adults with suspected diminished lung function and can potentially accelerate their ability to make informed treatment decisions at the point of care.
Butterfly’s Auto B-line Counter leverages deep learning technology to produce a B-line count from a six second ultrasound clip – a drastic change from traditionally manual, subjective counting processes to more consistent interpretation of B-lines. 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.
Dr. Jonathan Rothberg, Butterfly Network’s founder and interim chief executive officer, said: "Our goal at Butterfly is to give healthcare practitioners, and eventually consumers, a real time full colour, 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 clinician's hands, across specialities, 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."
Butterfly’s Auto B-line Counter algorithm utilises 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 simply place the probe and receive a reliable number count right on their screen.
To develop and train its AI algorithms, Butterfly uniquely utilises 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 U.S., offering potential for a broad and diverse range of age, gender, body mass index, ethnicity, and race. Continuing its credo to democratise healthcare by making medical imaging accessible to everyone around the world, Butterfly leverages this cloud data, in part, with the aim of creating more representative technology that the company believes will help bridge the divide in health technology experienced across diverse populations.
The company anticipates that the AI-enabled Auto B-line Counter will launch early summer in the United States.