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Butterfly Network Announces FDA Clearance of its Next-Generation Handheld Ultrasound System, Butterfly iQ3

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Butterfly Network, Inc. (BFLY) announces FDA clearance for Butterfly iQ3, a next-generation handheld point-of-care ultrasound system. The new device features advanced semiconductor technology, improved image resolution, sensitivity, and penetration, as well as faster 3D capabilities. It also introduces novel, automated image capture modes: iQ Slice and iQ Fan. Butterfly iQ3 is set to revolutionize digital ultrasound and make it more accessible and approachable than ever before.
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Insights

The FDA clearance of Butterfly Network's Butterfly iQ3 represents a significant advancement in the field of portable ultrasound technology. The device's enhanced capabilities, including its doubled data processing speed and new automated image capture modes, iQ Slice and iQ Fan, are poised to improve diagnostic efficiency and patient care. From an industry perspective, this technological leap could disrupt the traditional ultrasound market, which has long relied on piezoelectric-based systems. The iQ3's semiconductor technology not only offers a more compact and versatile solution but also aligns with the increasing demand for telehealth services and remote patient monitoring. The potential for market expansion into various healthcare settings, including emergency medicine, primary care and global health, could drive significant revenue growth for Butterfly Network.

Butterfly Network's introduction of the Butterfly iQ3 underscores a broader trend within the healthcare sector towards digitalization and miniaturization of medical devices. The FDA clearance is not only a regulatory milestone but also a signal of market readiness for more advanced POCUS systems. By offering a single-probe, whole-body ultrasound system, Butterfly Network is catering to a growing segment of healthcare professionals seeking integrated and user-friendly diagnostic tools. The company's claim of image quality on par with traditional handhelds could be a game-changer, potentially increasing adoption rates among clinicians. As healthcare providers continue to seek cost-effective and efficient diagnostic solutions, the iQ3's market penetration could be substantial, affecting the stock performance of not only Butterfly but also its competitors.

With the release of the Butterfly iQ3, investors should closely monitor Butterfly Network's financials in upcoming quarters for signs of impact from this product launch. The device's advanced semiconductor technology and new imaging modes could translate into higher sales volume, which in turn would affect the company's bottom line. The stock market reaction to such FDA clearances typically reflects anticipated future earnings potential. Butterfly Network's previous customer base of over 145,000 for its earlier models suggests a ready market for upgrades and new acquisitions. However, investors should also consider the capital required for research and development, marketing and sales efforts associated with launching a new product. The long-term financial impact will depend on the iQ3's commercial success and the company's ability to capitalize on the device's technological advantages.

Butterfly iQ3 brings unparalleled image quality and new digital imaging modes, iQ Slice and iQ Fan, powered by advanced semiconductor technology for easier, automated image acquisition

BURLINGTON, Mass. & NEW YORK--(BUSINESS WIRE)-- Butterfly Network, Inc. (“Butterfly”) (NYSE: BFLY), a digital health company transforming care through the power of portable, semiconductor-based ultrasound technology and intuitive software, today announced the FDA clearance of its next-generation handheld point-of-care ultrasound (POCUS) system, Butterfly iQ3. The new device is the company’s third iteration of the world’s first semiconductor-based single-probe, whole-body ultrasound system. Butterfly iQ3 features a brand-new ergonomic design and will deliver double the data processing speed for optimized image resolution, sensitivity and penetration, as well as faster 3D capabilities to power novel, automated image capture modes: iQ Slice and iQ Fan.

Butterfly iQ3 will feature a brand-new ergonomic design, to be revealed soon. (Graphic: Business Wire)

Butterfly iQ3 will feature a brand-new ergonomic design, to be revealed soon. (Graphic: Business Wire)

“Butterfly iQ3 is the turning point for digital ultrasound. Butterfly started a revolution in ultrasound when we commercialized the world’s first fully digital handheld ultrasound in 2018, and subsequently, iQ+ in 2020,” said Joseph DeVivo, Butterfly Network’s President, Chief Executive Officer and Chairman. “Over 145,000 customers have since realized the value of our chip-based ultrasound. With iQ3, the revolution takes full charge. Physicians across disciplines now rank our overall image quality at least equal to traditional piezoelectric-based handhelds, and our new digital capabilities are designed to make ultrasound more accessible and approachable than ever before.”

DeVivo continued, “I look forward to revealing more about iQ3’s advanced imaging capabilities this week at the 42nd Annual J.P. Morgan Healthcare Conference. Stay tuned for more details about the product and its commercial launch in the United States this quarter.”

DeVivo and Heather Getz, Butterfly Network’s Chief Financial and Operations Officer, will present at the J.P. Morgan Healthcare Conference on Thursday, January 11, 2024 at 9:00 am PT. Access the live webcast via the Events & Presentations section of Butterfly’s investor website.

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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 third generation iQ3 in 2024 – 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.

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, Inc.

FAQ

What is the latest product announced by Butterfly Network, Inc. (BFLY)?

Butterfly Network, Inc. (BFLY) announced the FDA clearance of its next-generation handheld point-of-care ultrasound system, Butterfly iQ3.

What are the key features of Butterfly iQ3?

Butterfly iQ3 features advanced semiconductor technology, improved image resolution, sensitivity, and penetration, as well as faster 3D capabilities. It also introduces novel, automated image capture modes: iQ Slice and iQ Fan.

Who is the President, CEO, and Chairman of Butterfly Network, Inc. (BFLY)?

Joseph DeVivo is the President, Chief Executive Officer, and Chairman of Butterfly Network, Inc. (BFLY).

How many customers have realized the value of Butterfly Network's chip-based ultrasound?

Over 145,000 customers have realized the value of Butterfly Network's chip-based ultrasound.

What is the potential impact of Butterfly iQ3 on the ultrasound industry?

Butterfly iQ3 is set to revolutionize digital ultrasound and make it more accessible and approachable than ever before.

Butterfly Network, Inc.

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