Butterfly Network (NYSE:BFLY) announced today that it garnered CE mark approval for its Butterfly iQ+ ultrasound system.
The company obtained European Union Medical Device Regulation (EU MDR) certification for the iQ+ system. It initially received CE mark in 2021, but had to fall in line with updated, more stringent regulations in Europe.
According to a news release, the additional certification allows Butterfly Network to release important new features to all existing and prospective European customers. That includes its pulse wave doppler (PWD) in presets and its AI-enabled auto B-line counter. Butterfly expects to roll out these additional functionalities within the second quarter of 2024.
The new feature release spans Europe, including Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, and the UK. Butterfly iQ+ can also now reach Australia and New Zealand, which accept CE mark.
According to the company, while it advances iQ+ in the near term, it now has a foundation to expand upon that. Butterfly hopes to launch its next-generation iQ3 device in Europe later this year as a result. The Butterfly iQ3 point-of-care ultrasound (POCUS) system is a semiconductor-based, single-probe, whole-body ultrasound offering. iQ3 features a brand-new ergonomic design and provides double the data processing speed compared to previous generations. The FDA cleared the iQ3 system in January.
“EU MDR certification is one of the most challenging regulatory milestones for medical device companies entering the EU Market,” said John Soto, SVP, 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.”