Butterfly Network Announces New FDA-Cleared AI-Enabled Lung Tool

Rhea-AI Summary

Butterfly Network has announced the 510(k) clearance for its groundbreaking AI-enabled Auto B-line Counter, enhancing lung condition assessments. Utilizing deep learning technology, this new tool simplifies the evaluation of abnormal lung conditions by counting B-lines from a quick ultrasound clip, significantly speeding up diagnosis and treatment. The algorithm is trained on a dataset of over 3.5 million de-identified ultrasound images sourced from across the U.S. The company aims to launch this innovative solution in early summer 2023, aiming to improve healthcare accessibility and democratize medical imaging.

Positive

• Received 510(k) clearance for AI-enabled Auto B-line Counter.
• Utilizes deep learning to expedite assessments of lung functions.
• Can produce a B-line count from a six-second ultrasound clip.
• Access to over 3.5 million ultrasound images enhances algorithm training.

Negative

• None.

New Auto B-line Counter uses deep learning technology with the aim of empowering providers to assess abnormal lung conditions easier, faster, and with more confidence

Butterfly’s cloud-based data collection protocol can access over 3.5 million de-identified ultrasound images to develop and train its AI algorithms

BURLINGTON, Mass.--(BUSINESS WIRE)-- Butterfly Network, Inc., a digital health company transforming care through the power of handheld, whole-body ultrasound, announced today that it has received 510(k) clearance for a groundbreaking AI-enabled Auto B-line Counter that may simplify how healthcare professionals evaluate adults with suspected diminished lung function and can potentially accelerate their ability to make informed treatment decisions at the point of care.

Butterfly’s Auto B-line Counter leverages deep learning technology to produce a B-line count from just a six second ultrasound clip – a drastic change from traditionally manual, subjective counting processes to more consistent interpretation of B-lines. B-lines on an ultrasound scan appear as bright, vertical lines that indicate wetness in the lungs and are associated with pulmonary air-space disease, such as congestive heart failure, chronic obstructive pulmonary disease, pneumonia and COVID-19.

"Our goal at Butterfly is to give healthcare practitioners, and eventually consumers, a real time full color, annotated, window into the human body. Applying AI to make ultrasound easier to use is core to Butterfly, and will enable powerful ultrasound to be in the palm of more clinician's hands, across specialities, to monitor, assess, and prescribe treatments in a more informed way," said Dr. Jonathan Rothberg, Butterfly Network’s Founder and Interim Chief Executive Officer. "Our AI-enabled Auto B-line Counter empowers providers to assess lung conditions faster and with more confidence – and in turn, will aid in earlier detection, diagnosis, and treatment of cardiovascular diseases, a leading cause of death globally, taking nearly 18 million lives each year.¹"

Butterfly’s Auto B-line Counter algorithm utilizes the state-of-the-art instant percent counting method that assigns numbers to confluent B-lines by the percentage of rib space occupied in addition to counting discrete B-lines – a technique that has been found to be more reliable than incumbent individual line counting methods.² With it, trained providers can simply place the probe and receive a reliable number count right on their screen.

To develop and train its AI algorithms, Butterfly uniquely utilizes its secure Butterfly Cloud to access over 3.5 million de-identified ultrasound cines. These data inputs come from hundreds of sites across all 50 states in the U.S., offering potential for a broad and diverse range of age, gender, body mass index, ethnicity, and race. Continuing its credo to democratize healthcare by making medical imaging accessible to everyone around the world, Butterfly leverages this cloud data, in part, with the aim of creating more representative technology that the company believes will help bridge the divide in health technology experienced across diverse populations.

The company anticipates that the AI-enabled Auto B-line Counter will launch early summer in the United States.

For more information on Butterfly Network and its innovative solutions, visit: https://www.butterflynetwork.com/.

About Butterfly Network

Founded by Dr. Jonathan Rothberg in 2011 and listed on the New York Stock Exchange through a business combination with Longview Acquisition Corp., Butterfly created the world's first handheld, single probe whole-body ultrasound system using semiconductor technology, the Butterfly iQ+. Butterfly's mission is to democratize medical imaging and contribute to the aspiration of global health equity, 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. Through its proprietary Ultrasound-on-Chip™ technology, Butterfly is paving the way for earlier detection and remote management of health conditions around the world. The Butterfly iQ+ can be purchased today by trained healthcare practitioners in areas including, but not limited to, parts of Africa, Asia, Australia, Europe, North America and South America; to learn more about available countries, visit: butterflynetwork.com/choose-your-country.

Butterfly iQ+ is a prescription device intended for trained healthcare professionals only.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. The Company’s actual results may differ from its expectations, estimates, and projections and, consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company’s expectations with respect to financial results, future performance, development of products and services, and the size and potential growth of current or future markets for its products and services. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from those discussed in the forward-looking statements. Most of these factors are outside the Company’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the impact of COVID-19 on the Company’s business, including issues relating to Omicron or other variants; the ability to recognize the anticipated benefits of the business combination; theCompany’s ability to grow and manage growth profitably; the success, cost and timing of the Company’s product and service development activities; the potential attributes and benefits of the Company’s products and services; the degree to which our products and services are accepted by healthcare practitioners and patients for their approved uses; the Company’s ability to obtain and maintain regulatory approval for its products, and any related restrictions and limitations of any approved product; the Company’s ability to identify, in-license or acquire additional technology; the Company’s ability to maintain its existing license, manufacture, supply and distribution agreements; manufacturing and supply of the Company’s products; the Company’s ability to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently marketing or developing; changes in applicable laws or regulations; the size and growth potential of the markets for the Company’s products and services, and its ability to serve those markets, either alone or in partnership with others; the pricing of the Company’s products and services and reimbursement for medical procedures conducted using its products and services; the Company’s estimates regarding expenses, revenue, capital requirements and needs for additional financing; the Company’s financial performance; the Company’s ability to raise financing in the future; and other risks and uncertainties indicated from time to time in the Company’s most recent Annual Report on Form 10-K or in subsequent filings that it makes with the Securities and Exchange Commission. The Company cautions that the foregoing list of factors is not exclusive. The Company cautions you not to place undue reliance upon any forward-looking statements, which speak only as of the date of this press release. The Company does not undertake or accept any obligation or undertake to release publicly any updates or revisions to any forward-looking statements to reflect any change in the Company’s expectations or any change in events, conditions or circumstances on which any such statement is based.

Required Disclosures:

℞ only. Caution: Federal law restricts this device to sale by or on the order of a trained healthcare practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device. Butterfly iQ/iQ+ is for external use only.

Butterfly iQ/iQ+ is indicated for use by trained healthcare professionals in environments where healthcare is provided to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients for specific clinical applications. Depending on your platform, hardware, country and membership type, certain presets, modes and features may not be available. Do not use the Butterfly iQ App on a mobile device that does not meet minimum requirements. Using the Butterfly iQ App on a mobile device that does not meet the minimum requirements may affect performance and image quality, possibly resulting in misdiagnosis. Consult your user manual.

Butterfly iQ/iQ+ produces ultrasound waves. Ultrasonic waves can heat the tissues slightly. Always use the ALARA (As Low As Reasonably Achievable) principle when performing an ultrasound study. Use the correct clinical application presets for the associated body part being examined for the appropriate duration of administration. Some applications may require lower acoustic output limits.

¹ World Health Organization. Cardiovascular diseases. https://www.who.int/health-topics/cardiovascular-diseases#tab=tab_1

² Inter-rater reliability of quantifying pleural B-lines using multiple counting methods,” J. Ultrasound Med. 2013; 32:115–120

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Butterfly Network Contacts:

Media

Liz Learned

Media@butterflynetwork.com

Investors

Heather Getz

investors@butterflynetwork.com

Source: Butterfly Network, Inc.

FAQ

What is the significance of Butterfly Network's AI-enabled Auto B-line Counter?

The Auto B-line Counter allows healthcare professionals to assess lung conditions more quickly and confidently, potentially improving patient outcomes.

When will Butterfly Network's Auto B-line Counter be available?

The Auto B-line Counter is anticipated to launch in early summer 2023 in the United States.

How does the Auto B-line Counter improve lung assessment?

It leverages deep learning to count B-lines more consistently from a short ultrasound clip, replacing traditional subjective methods.

What data supports the training of Butterfly Network's AI algorithms?

The AI algorithms are trained using over 3.5 million de-identified ultrasound images from a wide range of demographics across the U.S.

What healthcare conditions can the Auto B-line Counter help diagnose?

It helps in assessing conditions such as congestive heart failure, chronic obstructive pulmonary disease, pneumonia, and COVID-19.