Butterfly Network, Inc. (NYSE: BFLY), a digital health company known for its portable ultrasound system based on semiconductors and intuitive software, has announced that it has achieved its Certificate of Compliance with the European Medical Device Regulation (EU MDR) for the Butterfly iQ+ ultrasound system. This certification enables Butterfly to introduce new features to its European customers, including Pulse Wave Doppler (PWD) in multiple presets and an AI-enabled automatic B-line counter, expected to be released in the second quarter of 2024.
The Butterfly iQ ultrasound systems initially received the CE mark in April 2019, followed by iQ+ in early 2021 with an initial set of features. With the EU MDR in effect since May 26, 2021, Butterfly has worked diligently to secure this additional certification, demonstrating its commitment to delivering innovative solutions to healthcare professionals globally.
John Soto, Senior Vice President, International, emphasized the significance of EU MDR certification and expressed gratitude for the patience of customers awaiting these advanced imaging tools. The new features will be rolled out in key European markets and other CE mark-accepted regions like Australia and New Zealand.
The EU MDR certification not only allows Butterfly iQ+ devices to expand across Europe but also lays the groundwork for the launch of the feature-rich Butterfly iQ3 device in Europe later this year. Additional details on the new features will be provided during the upcoming quarter launch.
