Butterfly Network Receives FDA Clearance for AI-Enabled Lung Diagnostic Device

Digital health company, Butterfly Network, Inc., (NYSE: BFLY), has received 510(k) clearance for a groundbreaking AI-enabled device that may simplify how healthcare professionals evaluate patients with suspected diminished lung function.

Butterfly’s shares rose 22% in pre-market trading following the news this week.


 Butterfly’s Auto B-line Counter is able to produce a B-line count from just a six second ultrasound clip, using deep learning technology.

B-lines appear on ultrasound scans as bright, vertical lines that indicate wetness in the lungs. They are associated with pulmonary air-space disease, such as congestive heart failure, chronic obstructive pulmonary disease, pneumonia and COVID-19.

Butterfly’s technology has the potential to deliver a more consistent interpretation of B-lines, potentially accelerating clinicians’ ability to make informed treatment decisions at the point of care.

The company’s Auto B-line Counter algorithm utilizes the state-of-the-art 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.

 About Butterfly Network

Butterfly Network created the world’s first handheld, single probe whole-body ultrasound system using semiconductor technology, the Butterfly iQ+. The company’s mission is to democratize medical imaging and contribute to the aspiration of global health equity, making high-quality ultrasound affordable, easy-to-use, globally accessible, and intelligently connected, including for the 4.7 billion people around the world lacking access to ultrasound. Through its proprietary Ultrasound-on-Chip™ technology, Butterfly is paving the way for earlier detection and remote management of health conditions around the world. The Butterfly iQ+ can be purchased today by trained healthcare practitioners in areas including, but not limited to, parts of Africa, Asia, Australia, Europe, North America and South America.

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Butterfly Network Receives FDA Clearance for AI-Enabled Lung Diagnostic Device

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