Butterfly IQ gets FDA clearance for chip-based, smartphone-connected ultrasound

By Jonah Comstock
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New York City and Guilford, Connecticut-based Butterfly IQ has received FDA clearance for an iPhone-connected portable ultrasound scanner that uses an easy-to-manufacture semiconductor chip rather than the piezoelectric crystals used by traditional ultrasounds.

Because of the semiconductor chip, the device will be offered at a much lower price point than existing ultrasounds, including existing smartphone-connected devices like Philips' Lumify device which costs around $6,000 to buy or $2,300 per year to lease.

"Butterfly's Ultrasound-on-a-Chip technology enables a low-cost window into the human body, making high-quality diagnostic imaging accessible to anyone," Dr. Jonathan Rothberg, founder and chairman of Butterfly Network, said in a statement. "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."

The device is cleared for 13 different clinical use cases, including fetal, abdominal, cardiac, gynecological, urological, and pediatric use cases. It transfers the imagery directly to a user's iPhone via a cord and stores images in a HIPAA-compliant cloud.

According to the MIT Tech Review, Dr. John Martin, Butterfly Network's chief medical officer, found cancer in his own body when he tested the device after joining the company. That illustrates the potential of a low-cost ultrasound device.

"At less than $2,000, healthcare providers can purchase an easy-to-use, powerful, whole-body medical imaging system that fits in their pocket," Martin said in a statement. "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."

Butterfly plans to augment the hardware capabilities with artificial intelligence software that could help clinicians interpret the images the device picks up. The company hopes to launch those features via an upgrade in 2018.

"Deep learning and ultrasound imaging are a perfect combination," Butterfly IQ President Gioel Molinari said in a statement. "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."