FDA clears next-gen handheld ultrasound from Butterfly Network

Butterfly Network (NYSE:BFLY) announced today that it received FDA clearance for its next-generation handheld ultrasound system. […]

Butterfly Network (NYSE:BFLY) announced today that it received FDA clearance for its next-generation handheld ultrasound system.

BFLY shares were up more than 23% to $1.25 apiece on the news. MassDevice‘s MedTech 100 Index was up more than 1%.

The Butterfly iQ3 point-of-care ultrasound (POCUS) system marks the third iteration of the company’s technology. Burlington, Massachusetts- based Butterfly develops semiconductor-based, single-probe, whole-body ultrasound technology. iQ3 features a brand-new ergonomic design and provides double the data processing speed compared to previous generations.

According to a news release, the new system optimizes image resolution, sensitivity and penetration. It also enables faster 3D capabilities to power novel, automated image capture modes called iQ Slice and iQ Fan.

Butterfly’s technology goes beyond just point-of-care imaging, with recent developments in multiple new disciplines. In October, the company announced a foray into brain-computer interfaces through a deal with Forest Neurotech. Last month, the company partnered with Mendaera to commercialize a new surgical robotic system using ultrasound-on-chip technology.

“Butterfly iQ3 is the turning point for digital ultrasound. Butterfly started a revolution in ultrasound when we commercialized the world’s first fully digital handheld ultrasound in 2018, and subsequently, iQ+ in 2020,” said Joseph DeVivo, Butterfly Network’s president, CEO and chair. “Over 145,000 customers have since realized the value of our chip-based ultrasound. With iQ3, the revolution takes full charge. Physicians across disciplines now rank our overall image quality at least equal to traditional piezoelectric-based handhelds, and our new digital capabilities are designed to make ultrasound more accessible and approachable than ever before.”

The company plans to share more about iQ3 at this week’s 42nd annual J.P. Morgan Healthcare Conference.

Original article: (https://www.massdevice.com/fda-clears-next-gen-iq3-butterfly-network/)