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
ITC Infotech Strengthens Strategic Tech Partnership With British American Tobacco (BAT) in New Multi-year Mandate12.8.2026 12:30:00 CEST | Press release
ITC Infotech, a leading global technology services and solutions provider, today announced a landmark multi‑year strategic technology deal with British American Tobacco (BAT). Along with BAT, ITC Infotech will accelerate the transformation of BAT’s technology landscape to drive AI-enabled innovation, strengthen skills, and improve efficiencies. In this expanded partnership, ITC Infotech will provide technology services to BAT across Poland, Romania and India. ITC Infotech will also continue to collaborate with BAT to scale capabilities at the newly launched BAT Future Capabilities Centre in India, while supporting BAT’s existing technology hubs in Malaysia and Mexico. This new strategic deal will deepen an already well-established partnership between ITC Infotech and BAT, streamlining end-to-end technology delivery and improving speed, efficiency, and service quality. As part of the deal, ITC Infotech will strengthen its footprint and onshore capabilities in Europe, which will be strat
Gen Z Spending is Expected to Reach $12 Trillion by 2030. Here's Why That Doesn't Matter as Much as Brands Think12.8.2026 12:00:00 CEST | Press release
New NIQ report reveals consumers across generations are trading up and trading down in the same shopping basket, putting new pressure on middle-market products The biggest shift in consumer spending isn't generational—it's behavioral. New research from NielsenIQ (NYSE: NIQ) finds consumers across every age group are increasingly making the same calculation: where is a premium worth paying, and where can they save money instead? The result is a growing divide between premium and value products, while traditional middle-market offerings face mounting pressure. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260812239453/en/ Every generation is spending differently, but all are weighing value more carefully The findings come from NIQ's latest global report, A Tale of Two Consumers: The Polarized Mindsets Reshaping Global Consumption, developed in collaboration with World Data Lab. While Gen X accounted for $15.2 trillion in sp
Kinguin Renews Ravelin Partnership After Cutting Ecommerce Fraud to “Industry-Leading Low”12.8.2026 11:04:00 CEST | Press release
Leading games marketplace extends AI fraud prevention deal for further three years Ravelin automates real-time fraud defenses and supports growth to over 20 million customers Kinguin, a global digital games marketplace serving more than 20 million registered users, has renewed its partnership with AI-native fraud platform Ravelin. The agreement follows significant reductions in fraud and a shift to automated, scalable fraud detection. Since first partnering in 2018, Ravelin has helped Kinguin transform its approach to payment fraud. Kinguin has eliminated the need for real-time manual reviews, while overall fraud rates have declined by 87.5%. The renewal reflects growing confidence in AI-led fraud prevention at a time when ecommerce merchants face increasingly sophisticated attacks, particularly in the digital goods space where instant delivery also means instant results for fraudsters. Kinguin is where gaming and esports fans around the world can access their favorite games, choosing
Delhaize BeLux Achieves Up to 90% Forecast Accuracy Using SymphonyAI's AI-Driven Replenishment Platform12.8.2026 09:05:00 CEST | Press release
Ahold Delhaize grocery retailer deploys SymphonyAI across 600 stores and five distribution centers, cutting shrink and improving forecast accuracy by up to 10 percentage points When a grocery retailer operates under a pure B2B affiliate model, it cannot push excess inventory to its store partners — which means forecasting has to be right, or the distribution center absorbs the cost. SymphonyAI, a global leader in Vertical AI, today announced that Delhaize, part of the Ahold Delhaize Group, has deployed SymphonyAI's Demand Forecasting and Replenishment solutions across its 600-store affiliated network and five distribution centers in Belgium, replacing reactive, manually intensive ordering processes with an AI-driven, exception-based workflow. The Delhaize Le Lion / De Leeuw network has no less than 1113 stores in Belgium and Luxembourg. The store network consists of different formulas: Delhaize, Proxy, Shop&Go and louis delhaize. Customers can also shop online via www.delhaize.be, and
Align Technology Prevails in China Patent Infringement Action Against Angelalign12.8.2026 02:47:00 CEST | Press release
Align Technology, Inc. ("Align") (Nasdaq: ALGN), a leading global medical device company that designs, manufactures, and sells the Invisalign® System of clear aligners, today announced that the Jinan Intermediate People's Court in China issued a judgment in favor of Align in a patent infringement action against Angelalign Technology's operating subsidiaries in China ("Angel") (Hong Kong Stock Exchange: 6699.HK). In September 2025, Align filed a patent infringement action against Angel in the Jinan Intermediate People's Court, asserting Align’s patent related to extraction-gap-closure technology (CN113693748B). On August 10, 2026, the Jinan Intermediate People's Court issued a first-instance judgment finding that Angel's use of its MasterForce biomechanical simulation system and ATreat digital orthodontic treatment design system to generate A7 and A7 Speed premolar extraction treatment solutions infringes Align's patent rights. The court further found that the related aligner products m
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