Butterfly Network Obtains EU MDR Certification for Butterfly iQ+ Devices in Key European Markets

Rhea-AI Summary

Butterfly Network, Inc. attains EU MDR certification for Butterfly iQ+ ultrasound system, enabling the release of advanced features like Pulse Wave Doppler and Auto B-Line Counter to European customers. The company plans to launch these functionalities within the second quarter of 2024, paving the way for the upcoming Butterfly iQ3 device in Europe.

Insights

Medical Technology Analyst

The attainment of the EU MDR certificate for the Butterfly iQ+ ultrasound system by Butterfly Network, Inc. represents a significant regulatory milestone that can have a substantial impact on the company's European market presence. The introduction of Pulse Wave Doppler and AI-enabled Auto B-Line Counter features is a technological advancement that enhances the product's value proposition. From a medical technology perspective, the integration of these features signifies a step forward in diagnostic capabilities, potentially leading to improved patient outcomes and workflow efficiencies for healthcare providers.

Furthermore, the expansion of these advanced features to key European markets not only strengthens Butterfly's competitive edge but also indicates the company's commitment to innovation and regulatory compliance. This can translate into increased adoption rates and market penetration. However, it is essential to consider the competitive landscape, as other players may also be enhancing their offerings and the rate of technology adoption can vary across different healthcare systems.

Healthcare Market Analyst

From a market perspective, Butterfly Network's strategic move to enhance its Butterfly iQ+ system with new features and pursue the launch of Butterfly iQ3 in Europe aligns with the growing demand for portable and advanced medical imaging solutions. The certification under EU MDR not only ensures compliance with stringent European standards but also serves as a trust signal to potential customers, which could positively influence sales and market share.

Investors should monitor the company's performance in the upcoming quarters to assess the impact of these releases on revenue growth, particularly within the European sector. While the short-term effects may include increased R&D and marketing expenses, the long-term potential for revenue growth and market expansion could be significant, assuming successful adoption and utilization of the new features by healthcare professionals.

Financial Analyst

Butterfly Network's EU MDR certification for its Butterfly iQ+ system is a pivotal step that could be reflected in the company's financial health. This regulatory approval enables the company to unlock new revenue streams within the European market. Investors should consider the implications of this development on the company's top-line growth, given that the European healthcare market is a substantial segment of the global industry.

It is important to analyze the potential increase in operational costs associated with the launch and marketing of these new features, as well as the cost of compliance with EU MDR standards. Additionally, the company's ability to scale production to meet potential demand surges without compromising quality will be a critical factor in realizing financial benefits from this expansion.

• The Company will release important advanced new features, such as Pulse Wave Doppler and Auto B-Line Counter to European Butterfly iQ+ devices in the coming months.
• The certification also serves as the foundation for Butterfly’s active pursuit to launch its new Butterfly iQ3 device in Europe later this year.

BURLINGTON, Mass. & NEW YORK--(BUSINESS WIRE)-- 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240320879229/en/

Butterfly Media:

Liz Learned

Head of Corporate Communications, Butterfly

media@butterflynetwork.com

Butterfly Investors:

Heather Getz

Chief Financial and Operations Officers, Butterfly

investors@butterflynetwork.com

or

Neal Nagarajan

Sloane & Company

(301) 273-5662

nnagaragan@sloanepr.com

Source: Butterfly Network

FAQ

When will Butterfly Network release the advanced features like Pulse Wave Doppler and Auto B-Line Counter to European customers?

Butterfly Network plans to release these advanced features within the second quarter of 2024.

What certification did Butterfly Network recently attain for the Butterfly iQ+ ultrasound system?

Butterfly Network attained the European Union Medical Device Regulation (EU MDR) certificate for the Butterfly iQ+ ultrasound system.

Which key European markets will the new features extend to?

The new features 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.

What is the significance of the EU MDR certification for Butterfly Network?

The EU MDR certification allows Butterfly Network to release new, advanced capabilities to its European customers and serves as the foundation for launching the Butterfly iQ3 device in Europe later this year.