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Butterfly Network obtains EU MDR certification for Butterfly iQ+ devices in key European markets

Press releases may be edited for formatting or style | March 20, 2024 Ultrasound
BURLINGTON, Mass. & NEW YORK--(BUSINESS WIRE)--Butterfly Network, Inc. (“Butterfly”, “the Company”) (NYSE: BFLY), a digital health company transforming care through the power of portable, semiconductor-based ultrasound technology and intuitive software, today announced the attainment of its European Union Medical Device Regulation (EU MDR) certificate for the Butterfly iQ+ ultrasound system. This additional certification allows Butterfly to release important new features to all existing and prospective European customers, including Pulse Wave Doppler (PWD) in a number of presets and its AI-enabled Auto B-Line Counter. The Company intends to release these additional functionalities within the second quarter 2024.

The Butterfly iQ Ultrasound Systems first obtained CE Marking in April 2019, and subsequently, iQ+ in early 2021 with an initial set of features. On May 26, 2021, EU MDR came into effect as the new governing framework for the production and distribution of medical devices in Europe. Since then, Butterfly has been actively working to obtain this additional certification necessary to release new, advanced capabilities to its European customers.

“EU MDR certification is one of the most challenging regulatory milestones for medical device companies entering the EU Market,” said John Soto, Sr. Vice President, International. “We are incredibly proud of this achievement, which underscores our commitment to providing innovative solutions to healthcare professionals worldwide. We are grateful for the patience of our existing and future international customers who have been eagerly awaiting these additional imaging tools for enhanced real-time measurement accuracy.”
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The new feature release will extend to key European markets, including Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, and the UK. The capabilities will also extend to other key markets where the CE Mark is accepted, such as Australia and New Zealand. Additional details on new functionality will be provided at launch next quarter.

While EU MDR allows Butterfly iQ+ devices to advance in the near term throughout Europe, it also serves as the foundation for the Company’s active pursuit of launching its new, feature-rich Butterfly iQ3 device in Europe later this year.

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 a third generation iQ3 out in 2024 or 2025 depending on the country – 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

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