BFLY: FDA Approves Next-Gen iQ3

Butterfly iQ3 brings unparalleled image quality and new digital imaging modes, iQ Slice and iQ Fan, powered by advanced semiconductor technology for easier, automated image acquisition

Butterfly Network, Inc. (“Butterfly”) (NYSE: BFLY), a digital health company transforming care through the power of portable, semiconductor-based ultrasound technology and intuitive software, today announced the FDA clearance of its next-generation handheld point-of-care ultrasound (POCUS) system, Butterfly iQ3. The new device is the company’s third iteration of the world’s first semiconductor-based single-probe, whole-body ultrasound system. Butterfly iQ3 features a brand-new ergonomic design and will deliver double the data processing speed for optimized image resolution, sensitivity and penetration, as well as faster 3D capabilities to power novel, automated image capture modes: iQ Slice and iQ Fan.

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Butterfly iQ3 will feature a brand-new ergonomic design, to be revealed soon. (Graphic: Business Wire)

“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, Chief Executive Officer and Chairman. “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.”

DeVivo continued, “I look forward to revealing more about iQ3’s advanced imaging capabilities this week at the 42nd Annual J.P. Morgan Healthcare Conference. Stay tuned for more details about the product and its commercial launch in the United States this quarter.”

DeVivo and Heather Getz, Butterfly Network’s Chief Financial and Operations Officer, will present at the J.P. Morgan Healthcare Conference on Thursday, January 11, 2024 at 9:00 am PT. Access the live webcast via the Events & Presentations section of Butterfly’s investor website.

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About Butterfly Network

Founded by Dr. Jonathan Rothberg in 2011, Butterfly Network is a digital health company with a mission is to democratize medical imaging by making high-quality ultrasound affordable, easy-to-use, globally accessible, and intelligently connected, including for the 4.7 billion people around the world lacking access to ultrasound. Butterfly created the world's first handheld single-probe, whole-body ultrasound system using semiconductor technology, Butterfly iQ. The company has continued to innovate, leveraging the benefits of Moore’s Law, to launch its second generation Butterfly iQ+ in 2020, and third generation iQ3 in 2024 – each with increased processing power and performance enhancements. The disruptive technology has been recognized by TIME’s Best Inventions, Fast Company’s World Changing Ideas, CNBC Disruptor 50, and MedTech Breakthrough Awards, among other accolades. With its proprietary Ultrasound-on-Chip™ technology, intelligent software, and educational offerings, Butterfly is paving the way to mass adoption of ultrasound for earlier detection and remote management of health conditions around the world. Butterfly devices are commercially available to trained healthcare practitioners in areas including, but not limited to, parts of Africa, Asia, Australia, Europe, the Middle East, North America and South America; to learn more about available countries, visit: butterflynetwork.com/choose-your-country