FDA clears Butterfly Network’s iQ ‘ultrasound-on-a-chip’

Medical device developer Butterfly Network said today it won FDA 510(k) clearance for the Butterfly iQ Apple (NSDQ:AAPL) iPhone-connected Ultrasound system, which claims is the world’s first ultrasound-on-a-chip system.

The device is now indicated for 13 clinical applications, which the Guilford, Conn.-based company touts as the “broadest every for a single ultrasound transducer.”

“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, invented over 200 years ago. At less than $2,000, healthcare providers can purchase an easy-to-use, powerful, whole-body medical imaging system that fits in their pocket. 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,” chief medical officer Dr. John Martin said in a press release.

Butterfly said its device consists of a single wide-band, 2D matrix array with thousands of microelectromechanical systems overlaid on an integrated circuit.

The company touted that the cost of the device was significantly lower than existing technology, saying it could reduce costs between 10 to 100 times.

“Just as putting a camera on a semiconductor chip made photography accessible to anyone with a smart phone and putting a computer on a chip enabled the revolution in personal computing before that, Butterfly’s Ultrasound-on-a-Chip technology enables a low-cost window into the human body, making high-quality diagnostic imaging accessible to anyone. Two thirds of the world’s population has no access to medical imaging, that’s not ok, and today our team is doing something about it. And they are just getting started,” founder & chair Dr. Jonathan Rothberg said in a prepared release.

Butterfly said it plans to release assistance and interpretation functionality using deep learning-based artificial intelligence some time in 2018.

“Deep learning and ultrasound imaging are a perfect combination. As physicians use our devices in the field, they help improve the neural network models. The more physicians use Butterfly devices, the better they will get. Improvements to acquiring and interpreting images will ultimately enable less skilled users to reliably extract life-saving insight from ultrasound,” prez Gioel Molinari said in prepared remarks.

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