Butterfly Network, Inc. (“Butterfly”), a leading digital health company specializing in portable ultrasound technology, has announced the successful acquisition of European Union Medical Device Regulation (EU MDR) certification for its Butterfly iQ+ ultrasound system. This milestone allows Butterfly to introduce new functionalities to its European customers, including Pulse Wave Doppler (PWD) in multiple presets and the AI-enabled Auto B-Line Counter, expected to launch within the second quarter of 2024.
The Butterfly iQ Ultrasound Systems initially received CE Marking in April 2019, with the iQ+ variant following suit in early 2021. Since the enforcement of EU MDR on May 26, 2021, Butterfly has diligently pursued this additional certification to enhance its offerings in European markets.
John Soto, Senior Vice President, International at Butterfly Network, commented on the significance of this achievement, stating, “EU MDR certification is a significant milestone for medical device companies entering the EU Market. We are proud to provide innovative solutions to healthcare professionals worldwide and appreciate the patience of our customers awaiting these new imaging tools.”
The advanced features will be rolled out in key European markets, including Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, and the UK. Additionally, these capabilities will extend to other pivotal markets recognizing the CE Mark, such as Australia and New Zealand. Further details regarding the new functionalities will be disclosed upon launch next quarter.
The EU MDR certification not only facilitates the immediate advancement of Butterfly iQ+ devices across Europe but also lays the groundwork for the upcoming launch of the feature-rich Butterfly iQ3 device in Europe later this year. This development underscores Butterfly Network’s commitment to driving innovation in healthcare technology and enhancing patient care globally.
