World's first iPhone ultrasound receives FDA clearance


Butterfly Network announced Oct. 27 that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Butterfly iQ, a whole-body ultrasound-based imaging system built for an iPhone.

"Offering a unique blend of affordability, diagnostic versatility, and assistive intelligence, Butterfly has the potential to impact human health more profoundly than any diagnostic device since the stethoscope," said Butterfly Network's Chief Medical Officer John Martin, MD, in a statement.

The technology behind Butterfly iQ is similar to that of a typical ultrasound system, but it combines the capabilities of three probes into a single ultra wide-band, 2D matrix array comprised of thousands of microelectromechanical systems (MEMS), according to the press release. The "Ultrasound-on-a-chip" is also paired with a large data storage cloud and contains a deep learning-based artificial intelligence. In other words, the more clinicians use Butterfly iQ, the better it gets.

"Moving the ultrasound machine to a chip allows it to be produced at unprecedented scales, at prices and rates of improvements that obey Moore's law and will enable a series of future form factors," according to the press release.