Butterfly Network Receives EU MDR Certification for Butterfly iQ+ Ultrasound Systems in Key European Markets


Butterfly Network has received European Union Medical Device Regulation (EU MDR) certificate for the Butterfly iQ+ ultrasound system, allowing 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 Butterfly iQ Ultrasound Systems was first CE Marked in April 2019, followed by 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, which is required to release new, advanced capabilities to its European customers.

Butterfly Network intends to release these additional functionalities within the second quarter of 2024 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 be extended to other key markets where the CE Mark is accepted, such as Australia and New Zealand.

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