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
Darktrace Selects Navan to Modernise Travel Program25.2.2026 10:00:00 CET | Press release
Navan (NASDAQ: NAVN), the global AI-powered business travel and expense platform, today announced it has been selected by Darktrace, a global leader in AI for cybersecurity, to upgrade its global travel program. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260225522665/en/ Darktrace Selects Navan to Modernise Travel Program “As Darktrace accelerates its expansion, in-person collaboration is critical,” said David Smith, Chief People Officer at Darktrace. “Navan’s inventory and user experience will ensure our teams and customers can easily connect, while we can maintain financial control.” As the UK-based cybersecurity company grows, Darktrace sought a partner to consolidate its travel operations, minimize administrative burden, and improve the booking experience for its workforce. Previously hampered by fragmented processes, Darktrace required a solution that would increase platform adoption and empower its employees to tra
AI: The New Insider Threat Facing Organizations25.2.2026 09:00:00 CET | Press release
Thales 2026 Data Threat Report Finds 70% of Organizations Rank AI as Top Data Security Risk As AI systems gain broader access to enterprise data across environments, organizations must treat data visibility and encryption as core security elements. AI-enabled deepfakes and misinformation are increasing the effectiveness of identity-based attacks. Today, credential theft is the leading attack technique against cloud infrastructure (67%). Nearly 60% of companies report deepfake-driven incidents, and 48% experience damage from AI-generated misinformation Investment in AI security is growing, with 30% of companies allocating dedicated budgets; however, 53% are still relying on existing security budget According to the Thales 2026 Data Threat Report, organizations across various markets including automotive, energy, finance and retail say the rapid pace of AI-driven transformation is now their biggest security challenge. Based on the report’s research, conducted by S&P Global 451 Research,
Zuper and Vonage Reimagine Network Connectivity for Skilled Trades with Quality on Demand25.2.2026 09:00:00 CET | Press release
Zuper to receive early access to Vonage Quality on Demand network API, for high-stakes field workflows - ensuring reliable network performance for live video, wearables, and inspections across industries like HVAC, electrical, general construction, roofing, manufacturing, and more Zuper, the AI operating system for the trades, and Vonage, part of Ericsson, have entered into a Memorandum of Understanding (MoU) to enter into a collaboration to integrate Vonage’s network APIs into the Zuper platform. The collaboration will provide Zuper with early access to Vonage network powered solutions, starting with Quality on Demand (QoD), where mobile network performance can be selectively applied to support critical field workflows, delivering improved latency, reliability, and connected experiences for mobile workforces. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260225852261/en/ QoD is the first advanced network API being integrat
Industrial Decarbonization: Calderion, WenCo and Terravent Invest in Graforce to Scale Plasma Pyrolysis Globally25.2.2026 08:07:00 CET | Press release
The investor consortium comprising the Paris-based Next Generation Fuels Industrial & Technological fund Calderion (Audacia), alongside infrastructure developer Terravent and WenCo Family Office, announces the closing of a strategic double-digit million-euro financing round for Berlin-based Graforce GmbH. The investment is dedicated to the industrial scale-up of Graforce’s proprietary plasma pyrolysis technology, addressing the growing global demand for cost-efficient low-carbon hydrogen, syngas, and carbon removal solutions that are compatible with existing industrial infrastructures. Disruptive alternative to conventional processes Graforce’s technology aims at replacing CO₂-intensive legacy routes such as steam reforming and classical gasification. By applying plasma to methane, biogas, flare gas, and landfill gas, the process converts these streams into their valuable molecular components instead of emitting them. The result is a high-efficiency production of clean hydrogen and syn
Mevion Medical Systems Announces CE Marking of the MEVION S250-FIT™ Proton Therapy System, Expanding Global Access to Compact Proton Therapy25.2.2026 08:00:00 CET | Press release
CE Marking enables marketing and clinical use of the world’s first and only LINAC vault-ready proton therapy system across the European Union Mevion Medical Systems, the global leader in compact proton therapy, today announced that the MEVION S250-FIT Proton Therapy System has successfully completed the conformity assessment process and has received CE Marking under Regulation (EU) 2017/745 (EU MDR). This regulatory milestone enables the marketing, sale, and clinical use of the MEVION S250-FIT system throughout the European Union, building on the system’s existing U.S. FDA 510(k) clearance granted in September 2025. The MEVION S250-FIT is the first and only proton therapy system designed to fit into a standard radiation therapy vault. By enabling cancer centers to use their existing infrastructure, the MEVION S250-FIT dramatically reduces the cost, complexity, and timeline traditionally associated with proton therapy adoption. This opens a new pathway for hospitals and cancer centers a
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