Butterfly Network receives FDA 510(k) for AI-enabled lung tool

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Butterfly Network, maker of a handheld, smartphone-connected ultrasound system, received FDA 510(k) clearance for its Auto B-line Counter that leverages AI to help providers determine if a patient has abnormal lung function by measuring B-lines. 

B-lines on an ultrasound appear as bright lines and can be associated with various pulmonary conditions, such as chronic obstructive pulmonary disease and congestive heart failure. Butterfly’s algorithm determines the number of B-lines present, allowing providers to assess a patient’s lung condition. 

The company anticipates launching the product early this summer. 

“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 clinician’s hands, across specialities, to monitor, assess and prescribe treatments in a more informed way,” Dr. Jonathan Rothberg, Butterfly Network’s founder and interim CEO, said in a statement.  


After its FDA 510(k) clearance announcement last week, Butterfly’s stock price jumped 22%, though its price is lower today at around $2.26 than it was when it emerged on the public market in 2020 at $10.12. 

Last year, the company received a $5 million grant from the Bill and Melinda Gates Foundation to expand access to its imaging technology in Sub-Saharan Africa. 

In December, Butterfly announced the completion of phase one of its deployment and training program in Kenya, providing 500 Butterfly iQ+ devices (the company’s FDA 510(k) cleared flagship product) and training 1,000 healthcare workers to use the device.

The Massachusetts-based company is preparing to test the second-generation Butterfly IQ+ in space. This summer, it will join Space X’s Polaris Dawn mission, bringing its device to the International Space Station and testing it alongside numerous other healthcare offerings.  

Matthew Fisher will offer more detail in the HIMS23 session “A Confusing Muddle: Health Policy Post-Dobbs.” It is scheduled for Tuesday, April 18, at 3 p.m. – 4 p.m. CT at the South Building, Level 1, S100 C.


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