Butterfly Network’s RoHS Lead Exemption Revocation Request Progresses to Stakeholder and Consultant Assessment
9.6.2025 14:00:00 CEST | Business Wire | Press release
Oeko-Institut appointed for third-party evaluation; stakeholder consultation will run June 6, 2025 - August 1, 2025
Butterfly Network, Inc. (“Butterfly”, “the Company”) (NYSE: BFLY), a digital health company transforming care with handheld, whole-body ultrasound, today announced that the European Commission has officially initiated the review and stakeholder consultation period for the Company’s request to revoke Annex IV n. 14 of the European Commission’s Restriction of Hazardous Substances (RoHS) Directive – a temporary exemption historically granted for lead in single crystal piezoelectric materials for ultrasonic transducers.
Following Butterfly’s revocation submission in October 2024, the Commission has now appointed the Oeko-Institut as consultant to lead the technical assessment of the request, including a third-party evaluation. The stakeholder consultation questionnaire is open and will run from June 6, 2025 to August 1, 2025, allowing interested parties to submit feedback. A recommendation by the Oeko-Institut to the European Commission on the request is expected by Q2 of 2026. If favorable and after final adoption of the Delegated Act indicating the change of scope in the exemption, it will take 12 to 18 months for it to enter into legal force.
“We’re encouraged to see that the formal review of our revocation request is underway and grateful to the Commission and the Oeko-Institut for their attention to this matter,” said Joseph DeVivo, President, CEO & Chairman of Butterfly. “We remain optimistic about the opportunity to align ultrasound manufacturing with the EU’s broader circular economy and sustainability goals and modernize standards that better reflect today’s innovations in medical imaging.”
Input from relevant stakeholders is welcomed as part of the consultation process. Registration to receive updates or to get involved can be accessed here: https://rohs.exemptions.oeko.info/index.php?id=4
About Butterfly Network
Butterfly Network, Inc. (NYSE: BFLY) is a healthcare company driving a digital revolution in medical imaging with its proprietary Ultrasound-on-Chip™ semiconductor technology and ultrasound software solutions. In 2018, Butterfly launched the world’s first handheld, single-probe, whole-body ultrasound system, Butterfly iQ. The iQ+ followed in 2020, and the iQ3 in 2024, each with improved processing power and performance by leveraging Moore’s Law. The iQ3 earned Best Medical Technology at the 2024 Prix Galien USA Awards, a prestigious honor and one of the highest accolades in healthcare. Butterfly’s innovations have also been recognized by Fierce 50, TIME’s Best Inventions and Fast Company’s World Changing Ideas, among other achievements.
Butterfly combines advanced hardware, intelligent software, AI, services, and education to drive adoption of affordable, accessible imaging. Clinical publications demonstrate that its handheld ultrasound probes paired with Compass™ enterprise workflow software, can help hospital systems improve care workflows, reduce costs, and enhance provider economics. With a cloud-based solution that enables care anywhere through next-generation mobility, Butterfly aims to democratize healthcare by addressing critical global healthcare challenges. Butterfly devices are commercially available to trained healthcare practitioners in areas including, but not limited to, parts of Africa, Asia, Australia, Europe, the Middle East, North America and South America; to learn more about available countries, visit: https://www.butterflynetwork.com/choose-your-country.
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