Michael Barbella, Managing Editor05.06.24
Butterfly Network Inc. has received an EU Medical Device Regulation (EU MDR) certificate for the Butterfly iQ+ ultrasound system. With this certification, the company can now release new features to all existing and prospective European customers, including Pulse Wave Doppler (PWD) in various presets and its artificial intelligence-enabled Auto B-Line Counter.
Butterfly Network will release these additional functionalities this quarter.
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, senior vice president, International, at Butterfly Network. “We are proud of this achievement, which underscores our commitment to providing solutions to healthcare professionals worldwide. We are grateful for the patience of our existing and future international customers who have been 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 United Kingdom. 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.
Founded by Dr. Jonathan Rothberg in 2011, Butterfly Network is a digital health company that is attempting to make ultrasound affordable, easy-to-use, globally accessible, and intelligently connected. Butterfly created the world's first handheld single-probe, whole-body ultrasound system using semiconductor technology, Butterfly iQ. The company launched its second generation Butterfly iQ+ in 2020, and a third generation iQ3—each with increased processing power and performance enhancements. The 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 striving for mass adoption of ultrasound for earlier detection and remote management of health conditions. Butterfly devices are commercially available in parts of Africa, Asia, Australia, Europe, the Middle East, North America, and South America.
Butterfly Network will release these additional functionalities this quarter.
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, senior vice president, International, at Butterfly Network. “We are proud of this achievement, which underscores our commitment to providing solutions to healthcare professionals worldwide. We are grateful for the patience of our existing and future international customers who have been 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 United Kingdom. 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.
Founded by Dr. Jonathan Rothberg in 2011, Butterfly Network is a digital health company that is attempting to make ultrasound affordable, easy-to-use, globally accessible, and intelligently connected. Butterfly created the world's first handheld single-probe, whole-body ultrasound system using semiconductor technology, Butterfly iQ. The company launched its second generation Butterfly iQ+ in 2020, and a third generation iQ3—each with increased processing power and performance enhancements. The 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 striving for mass adoption of ultrasound for earlier detection and remote management of health conditions. Butterfly devices are commercially available in parts of Africa, Asia, Australia, Europe, the Middle East, North America, and South America.