MA-BUTTERFLY-NETWORK
20.3.2024 13:01:27 CET | Business Wire | Press release
Butterfly Network, Inc. (“Butterfly”, “the Company”) (NYSE: BFLY), a digital health company transforming care through the power of portable, semiconductor-based ultrasound technology and intuitive software, today announced the attainment of its European Union Medical Device Regulation (EU MDR) certificate for the Butterfly iQ+ ultrasound system. This additional certification allows 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 Company intends to release these additional functionalities within the second quarter 2024.
The Butterfly iQ Ultrasound Systems first obtained CE Marking in April 2019, and subsequently, 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 necessary to release new, advanced capabilities to its European customers.
“EU MDR certification is one of the most challenging regulatory milestones for medical device companies entering the EU Market,” said John Soto, Sr. Vice President, 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.”
The new feature release will extend 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 extend to other key markets where the CE Mark is accepted, such as Australia and New Zealand. Additional details on new functionality will be provided at launch next quarter.
While EU MDR allows Butterfly iQ+ devices to advance in the near term throughout Europe, it also serves as the foundation for the Company’s active pursuit of launching its new, feature-rich Butterfly iQ3 device in Europe later this year.
For more information about Butterfly and its ultrasound devices, please visit https://www.butterflynetwork.com/iq-plus.
About Butterfly Network
Founded by Dr. Jonathan Rothberg in 2011, Butterfly Network is a digital health company with a mission is to democratize medical imaging by making high-quality ultrasound affordable, easy-to-use, globally accessible, and intelligently connected, including for the 4.7 billion people around the world lacking access to ultrasound. Butterfly created the world's first handheld single-probe, whole-body ultrasound system using semiconductor technology, Butterfly iQ. The company has continued to innovate, leveraging the benefits of Moore’s Law, to launch its second generation Butterfly iQ+ in 2020, and a third generation iQ3 out in 2024 or 2025 depending on the country – each with increased processing power and performance enhancements. The disruptive technology has been recognized by TIME’s Best Inventions, Fast Company’s World Changing Ideas, CNBC Disruptor 50, and MedTech Breakthrough Awards, among other accolades. With its proprietary Ultrasound-on-Chip™ technology, intelligent software, and educational offerings, Butterfly is paving the way to mass adoption of ultrasound for earlier detection and remote management of health conditions around the world. 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: butterflynetwork.com/choose-your-country.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240320879229/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
From Network Automation to Agentic NetOps: NetBrain Sets the Standard for Deploying AI in Network Operations29.5.2026 15:00:00 CEST | Press release
Newest expansion of the NetBrain platform delivers Agent Skills, AI Path Doctor, MCP Server, and expanded cross-domain integrations, extending the agentic capabilities already running in production at hundreds of enterprises. NetBrain Technologies, Inc. today announced major new platform features that advance Agentic NetOps from an emerging category to operational reality. NetBrain's clients are already deploying agents that are diagnosing and remediating issues across complex multi-vendor enterprise networks. These new features further extend the platform with new agent tooling, cross-domain context, and open interfaces for the broader agentic enterprise. Early customer outcomes show the magnitude of the shift: A leading health insurer used NetBrain's Deep Diagnosis agent to diagnose and resolve a weeks old VPN connectivity issue in under five minutes. A large manufacturer resolved a critical device issue with a single prompt, isolating the root cause across the network path in under
Adtran resolves long-running patent litigation, reinforcing commitment to defend innovation29.5.2026 14:00:00 CEST | Press release
News summary: Non-practicing entity litigation continues to create costly, time-consuming pressure across the technology industry Adtran has reached a full settlement following counterclaims, with payment made to Adtran and all claims dismissed with prejudice Outcome reflects Adtran’s commitment to defend its innovations, customers and business against meritless patent assertions Adtran today announced it has resolved a patent litigation matter, resulting in a full settlement and dismissal of all claims with prejudice. The case, initiated in 2020 by a non-practicing entity asserting five patents, was transferred to the US District Court for the Northern District of Alabama in 2021 following a successful motion by Adtran. Adtran subsequently filed counterclaims, including bad-faith patent assertion under Alabama statutory law. The settlement includes payment to Adtran to resolve its counterclaims. Terms of the agreement remain confidential. “This outcome reflects a disciplined and consi
Meiji Seika Pharma Invests in GHIC’s Global Health Security Fund29.5.2026 13:00:00 CEST | Press release
Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo, Japan; President and Representative Director: Toshiaki Nagasato) today announced that it has committed to invest in the Global Health Security Fund (GHSF), which is sponsored by Global Health Investment Corporation (GHIC), a New York-based nonprofit organization. Through this investment, Meiji Seika Pharma will support the acceleration of innovations addressing critical global health challenges, including pandemic preparedness and antimicrobial resistance (AMR). GHIC is a mission‑driven nonprofit organization that deploys private investment strategies to generate both global health impact and financial returns. GHIC recently closed its second fund in GHSF. With more than a decade of experience investing in the field of infectious disease, GHIC has contributed to addressing major global health challenges. Its portfolio companies have successfully commercialized more than a dozen products, collectively reaching over 600 million people wo
IFF Enters Into Agreement to Sell Its Food Ingredients Business to CVC29.5.2026 12:50:00 CEST | Press release
Transaction advances portfolio transformation, sharpens focus on higher-growth, higher-margin businesses, strengthens balance sheet, and enhances value creation for shareholders IFF (NYSE: IFF), a global leader in flavors, fragrances, food ingredients, and health and biosciences, today announced that it has entered into an agreement to sell its Food Ingredients business to funds advised by CVC Capital Partners, a leading global private markets manager, in a transaction that values the business at approximately $4.3 billion, representing an enterprise value-to-EBITDA multiple of approximately 10x. As part of the transaction, IFF has chosen to retain an approximately 10% minority equity interest in the business, or approximately $200 million, permitting continued collaboration and cooperation between IFF and Food Ingredients and allowing IFF and its shareholders to participate in future value creation under its new ownership. The transaction marks a significant step in IFF’s portfolio tr
BeOne Medicines Establishes Standard for Long-Term Disease Control in CLL with BRUKINSA 78-Month Data at ASCO 202629.5.2026 12:00:00 CEST | Press release
Data represents the longest reported follow-up for a next-generation BTK inhibitor in CLL, showing sustained disease control and benefit that extends beyond first-line therapyBRUKINSA plus next-generation BCL2 inhibitor sonrotoclax (ZS) delivered deep, durable, and rapid uMRD responses, raising the bar for potential time-limited treatments in CLLData reinforce BeOne’s leadership in CLL and the strength of its foundational hematology franchise BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, is advancing the treatment paradigm in chronic lymphocytic leukemia (CLL) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. With extensive long-term follow-up, the SEQUOIA study of BRUKINSA® (zanubrutinib) reinforces its role as the foundational BTK inhibitor, showing sustained disease control over years of therapy. These findings are further supported by real-world evidence across three large analyses encompassing more than 250,000 pati
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom