Butterfly Network Obtains EU MDR Certification for Butterfly iQ+ Devices in Key European Markets
March 20 2024 - 8:00AM
Business Wire
- The Company will release important advanced new features, such
as Pulse Wave Doppler and Auto B-Line Counter to European Butterfly
iQ+ devices in the coming months.
- The certification also serves as the foundation for Butterfly’s
active pursuit to launch its new Butterfly iQ3 device in Europe
later this year.
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.”
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.
For more information about Butterfly and its ultrasound devices,
please visit https://www.butterflynetwork.com/iq-plus.
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; to learn more about available countries,
visit: butterflynetwork.com/choose-your-country.
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version on businesswire.com: https://www.businesswire.com/news/home/20240320879229/en/
Butterfly Media: Liz Learned Head of Corporate
Communications, Butterfly media@butterflynetwork.com
Butterfly Investors: Heather Getz Chief Financial and
Operations Officers, Butterfly investors@butterflynetwork.com or
Neal Nagarajan Sloane & Company (301) 273-5662
nnagaragan@sloanepr.com
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