Butterfly Community receives FDA 510(okay) for AI-enabled lung software


Butterfly Network, maker of a handheld, smartphone-connected ultrasound system, acquired FDA 510(k) clearance for its Auto B-line Counter that leverages AI to assist suppliers decide if a affected person has irregular lung operate by measuring B-lines. 

B-lines on an ultrasound seem as vivid traces and might be related to numerous pulmonary situations, resembling power obstructive pulmonary illness and congestive coronary heart failure. Butterfly’s algorithm determines the variety of B-lines current, permitting suppliers to evaluate a affected person’s lung situation. 

The corporate anticipates launching the product early this summer season. 

“Our purpose at Butterfly is to offer healthcare practitioners, and ultimately customers, a real-time, full-color, annotated window into the human physique. Making use of AI to make ultrasound simpler to make use of is core to Butterfly and can allow highly effective ultrasound to be within the palm of extra clinician’s fingers, throughout specialities, to watch, assess and prescribe remedies in a extra knowledgeable approach,” Dr. Jonathan Rothberg, Butterfly Community’s founder and interim CEO, stated in a press release.  


After its FDA 510(okay) clearance announcement final week, Butterfly’s stock price jumped 22%, although its worth is decrease as we speak at round $2.26 than it was when it emerged on the general public market in 2020 at $10.12. 

Final yr, the corporate acquired a $5 million grant from the Invoice and Melinda Gates Basis to broaden entry to its imaging know-how in Sub-Saharan Africa. 

In December, Butterfly announced the completion of phase one of its deployment and coaching program in Kenya, offering 500 Butterfly iQ+ units (the corporate’s FDA 510(k) cleared flagship product) and coaching 1,000 healthcare staff to make use of the system.

The Massachusetts-based firm is getting ready to check the second-generation Butterfly IQ+ in space. This summer season, it should be part of House X’s Polaris Daybreak mission, bringing its system to the Worldwide House Station and testing it alongside numerous other healthcare offerings.  

Matthew Fisher will provide extra element within the HIMS23 session “A Complicated Muddle: Well being Coverage Submit-Dobbs.” It’s scheduled for Tuesday, April 18, at 3 p.m. – 4 p.m. CT on the South Constructing, Degree 1, S100 C.

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