04 Apr 2023

Butterfly lands FDA clearance for AI-enabled lung ultrasound technology

Digital health company Butterfly Network has received FDA 510(k) clearance for its artificial intelligence (AI) - enabled B-line counter. The hand-held ultrasound technology aims to enable providers to assess lung function, aid early diagnosis and accelerate their ability to make treatment decisions at the point of care. 


B-lines are bright,vertical lines that denote wetness on the lungs. According to Butterfly, the presence of B-lines correlates with pulmonary diseases such as chronic obstructive pulmonary disease (COPD), congestive heart failure, pneumonia, and COVID-19. Butterfly’s automatic B-line counter utilises deep learning technology to produce a B-line count from a six-second ultrasound clip. This is achieved by the algorithm assigning numbers to the confluent B-lines as a percentage of the rib-space occupied, as well as a discrete B-line count. 


Butterfly’s algorithm was developed using the Butterfly Cloud, enabling access to over 3.5 million de-identified ultrasound cines. The data was gleaned from hundreds of sites across the U.S, to include a wide range of age, gender, body mass index, ethnicity, and race, with the aim of creating a more representative technology. 


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