Butterfly Network’s RoHS Lead Exemption Revocation Request Progresses to Stakeholder and Consultant Assessment
June 09 2025 - 8:00AM
Business Wire
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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version on businesswire.com: https://www.businesswire.com/news/home/20250609884142/en/
Media: Liz Learned Head of Communications, Butterfly
media@butterflynetwork.com
Butterfly Investors: Heather Getz Chief Financial
and Operations Officers, Butterfly
investors@butterflynetwork.com
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