Butterfly Network gains FDA clearance for ultrasound-on-a-chip based imaging system

Butterfly Network announced Friday that it received FDA 510(k) clearance for the Butterfly iQ for iPhone, which the company said is the "world's first ultrasound-on-a-chip based imaging system." The clearance covers 13 clinical applications, including abdominal, cardiac, foetal, gynaecological, musculoskeletal and small organ, which Butterfly Network indicated is "the broadest ever for a single ultrasound transducer."

John Martin, chief medical officer, said that the Butterfly iQ, which will cost less than $2000, "has the potential to impact human health more profoundly than any diagnostic device since the stethoscope." He noted that "healthcare providers can purchase an easy-to-use, powerful, whole-body medical imaging system that fits in their pocket," adding "by removing the barrier of price, I expect Butterfly to ultimately replace the stethoscope in the daily practice of medicine."

According to the company, its ultrasound-on-a-chip technology combines the capabilities of the three piezoelectric-based transducers required in traditional ultrasound systems "into a single ultra-wide-band, 2D matrix array comprised of thousands of microelectromechanical systems." Butterfly iQ features almost 10,000 sensors, which are directly overlaid on an integrated circuit, with Butterfly Network noting that "moving the ultrasound machine to a chip allows it to be produced at unprecedented scales."

Further, Butterfly Network said that it has developed deep learning-based artificial intelligence applications to assist clinicians with image acquisition and interpretation, which it plans to release in 2018 as a software add-on to the Butterfly iQ system. President Gioel Molinari remarked that "as physicians use our devices in the field, they help improve the neural network models," adding "improvements to acquiring and interpreting images will ultimately enable less skilled users to reliably extract life-saving insight from ultrasound." The company noted that Butterfly iQ is paired with a "HIPAA-compliant cloud which enables image storage and collaboration among clinicians as well as connectivity with traditional hospital medical record systems."

Other portable ultrasound devices include Philips' Lumify, its first app-based ultrasound solution, which costs around $6000 and uses traditional piezoelectric crystal technology.  

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