Butterfly Network’s smartphone plug-in ultrasound wins FDA nod

Butterfly Network’s ultrasound-on-a-chip technology snagged the FDA nod for 13 applications, the broadest clearance to date for an ultrasound transducer. The pocket-sized transducer, which plugs into an iPhone, would expand the availability of diagnostic ultrasound imaging.

Traditional cart-based ultrasound machines comprise at least three transducers and are bulky, so they can be hard to get hold of or maneuver in the emergency room. They also use ceramic crystal materials called piezoelectrics to generate and receive sound, the National Institute of Biomedical Imaging and Bioengineering says.

Butterfly Network’s iQ device uses its ultrasound-on-a-chip technology, which integrates the capabilities of the three typical ultrasound probes into a single 2D matrix array comprised of thousands of microelectromechanical systems, the company said. This array is overlaid on an integrated circuit with electronics like those found in high-performance ultrasound systems.

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A physician uses the hand-held device to scan a patient’s body and sees the imaging on an iPhone. Because the iQ system combines three transducers in one, the physician does not need to switch out transducers to conduct imaging on a different part of the body, saving valuable time. The images are then sent to the cloud for storage.

"Butterfly's Ultrasound-on-a-Chip technology enables a low-cost window into the human body, making high-quality diagnostic imaging accessible to anyone," said Butterfly CEO and founder Jonathan Rothberg in the statement. "Two-thirds of the world's population has no access to medical imaging, … and today our team is doing something about it. And they are just getting started."

Butterfly’s iQ is cleared for diagnostic imaging in 13 clinical applications, including musculoskeletal, cardiac and peripheral vessel applications. The device is priced at less than $2,000 and Butterfly will begin shipping systems in 2018.

"By removing the barrier of price, I expect Butterfly to ultimately replace the stethoscope in the daily practice of medicine. We can now provide a diagnostic system to address the millions of children that die of pneumonia each year and the hundreds of thousands of women that die in childbirth, and these are just two examples of the impact this technology will have,” said John Martin, M.D., Butterfly’s chief medical officer.

Philips has been working on a hand-held ultrasound too, but its Lumify smart-device system uses three transducers, like traditional systems. Last fall, the FDA cleared a cardiac transducer for use with Lumify, alongside two other transducers for OB/GYN and focused assessment with sonography for trauma examinations.