Hyperfine Announces FDA Clearance of Software Update That Enables Faster Acquisition of Best-in-Class Ultra-Low-Field Brain Images

Rhea-AI Summary

Hyperfine (Nasdaq: HYPR) has received FDA clearance for its ninth-generation AI-powered Swoop® system software, significantly reducing scan times for brain imaging without compromising image quality. This advancement positions Hyperfine as a leader in AI-powered health technology, potentially speeding up diagnoses in acute care settings, particularly for time-sensitive conditions like stroke. The software update may also help mitigate the impact of patient motion on image quality.

Professor Adnan Siddiqui from the University of Buffalo highlighted the importance of this development for stroke diagnosis workflows. Hyperfine's commitment to AI innovation is evident in its leading position on the FDA's AI/ML-Enabled Medical Devices list. Tom Teisseyre, Chief Operating Officer at Hyperfine, emphasized the company's focus on balancing speed and image quality to inform better patient care decisions in acute settings.

Positive

• FDA clearance of ninth-generation AI-powered Swoop® system software
• Significant reduction in scan times without sacrificing image quality
• Potential to speed up diagnostic processes in acute care settings
• Leading position on FDA's AI/ML-Enabled Medical Devices list
• Improved workflow integration for stroke diagnosis

Negative

• None.

Medical Research Analyst

The FDA clearance of Hyperfine's ninth-generation AI-powered Swoop® system software is a significant advancement in medical imaging technology. Reducing scan times without compromising image quality directly addresses two critical issues in medical imaging: speed and accuracy. This is particularly important in acute care settings where timely diagnostic information is essential. For conditions like stroke, where every second counts, rapid imaging capabilities can make a substantial difference in patient outcomes.

The integration of AI into medical imaging aligns with broader industry trends towards leveraging AI for improved diagnostic accuracy and efficiency. However, the uniqueness of Hyperfine’s portable MR system is its ability to bring advanced imaging directly to bedside, particularly in emergency situations. This can be a game-changer for hospitals with limited access to traditional MRI machines or in situations where patient transport is risky or impractical.

In the long term, this development could potentially reduce healthcare costs by enabling faster diagnostics and better utilization of healthcare resources. However, it remains to be seen how quickly hospitals and other medical facilities will adopt this new technology.

Financial Analyst

From a financial perspective, this FDA clearance reinforces Hyperfine's position in the market as a leader in AI-powered medical devices. The approval of the ninth-generation software not only enhances the value proposition of the Swoop® system but also strengthens Hyperfine's competitive edge in the industry.

Investors should note that FDA clearances often serve as a catalyst for stock performance, given the regulatory hurdles and the potential market exclusivity they imply. Additionally, the focus on reducing scan times addresses a critical need in the healthcare industry, potentially increasing demand for Hyperfine's products.

Another factor to consider is the strategic importance of adding AI capabilities to medical devices. This trend is likely to attract more attention from institutional investors who are focused on innovative technologies with significant growth potential. However, it is essential to monitor the company's financial reports to see how these technological advancements translate into revenue growth and profitability.

The total number of Hyperfine AI-powered marketing authorizations places the company in a leading position on recently published FDA list.

GUILFORD, Conn.--(BUSINESS WIRE)-- Hyperfine (Nasdaq: HYPR), the groundbreaking medical device company that has redefined brain imaging with the world’s first FDA-cleared portable magnetic resonance brain imaging system—the Swoop® system—today announced the clearance of the ninth generation of AI-powered Swoop® system software. This advanced software significantly reduces scan times across multiple MR sequences without sacrificing image quality. The U.S. Food and Drug Administration (FDA) clearance of this software further solidifies Hyperfine as a leader in AI-powered health technology.

These scan time reductions may enable Swoop® system images to help speed up the diagnostic process in acute care settings, which is crucial for time-sensitive medical conditions such as stroke, where every second counts. Reducing the overall acquisition time for sequences can also decrease the negative impact of patient motion on image quality.

Professor Adnan Siddiqui, MD, PhD, from the University of Buffalo, emphasized the impact of rapid imaging capabilities, saying, “Timely MR brain imaging is essential for clinicians making critical treatment decisions, particularly in acute neurological episodes like strokes. We have been an active site in the ACTION PMR study assessing the use of the Swoop® system in stroke diagnosis, and this latest software will help the Swoop® system more seamlessly integrate into stroke workflows. It is wonderful to see Hyperfine respond quickly to clinical feedback and continue to innovate to improve the Swoop® system.”

The total number of Hyperfine AI-powered marketing authorizations places the company in a leading position on the FDA’s Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices¹ list, underscoring the commitment of Hyperfine to leveraging AI to advance ultra-low-field portable MR brain imaging technology and improve patient care.

“With the release of our ninth-generation AI-powered software, we continue to broaden the clinical utility and workflow fit of the Swoop® system,” said Tom Teisseyre, Chief Operating Officer at Hyperfine. “The balance between speed and image quality is crucial in acute care settings where early and timely information is essential to inform the best decisions for patients. We’re proud of every step we’ve taken with the Swoop® system, learning from and responding to our user base and the broader medical community.”

For more information about the Swoop® Portable MR Imaging® system, please visit hyperfine.io.

About the Swoop® Portable MR Imaging® System

The Swoop® Portable MR Imaging® system is U.S. Food and Drug Administration (FDA) cleared for brain imaging of patients of all ages. It is a portable, ultra-low-field magnetic resonance imaging device for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The Swoop® system also has CE certification in the European Union and UKCA certification in the United Kingdom. The Swoop® system is commercially available in a select number of international markets.

About Hyperfine, Inc.

Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of care. The mission of Hyperfine, Inc. is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging. Founded by Dr. Jonathan Rothberg in a technology-based incubator called 4Catalyzer, Hyperfine, Inc. scientists, engineers, and physicists developed the Swoop® system out of a passion for redefining brain imaging methodology and how clinicians can apply accessible diagnostic imaging to patient care. For more information, visit hyperfine.io.

The Hyperfine logo, Swoop, and Portable MR Imaging are registered trademarks of Hyperfine, Inc.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Actual results of Hyperfine, Inc. (the “Company”) 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 goals and commercial plans, the benefits of the Company’s products and services, and the Company’s future performance and its ability to implement its strategy. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside of the Company’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the success, cost and timing of the Company’s product development and commercialization activities, including the degree that the Swoop® system is accepted and used by healthcare professionals; the impact of COVID-19 on the Company’s business; the inability to maintain the listing of the Company’s Class A common stock on the Nasdaq; the Company’s inability to grow and manage growth profitably and retain its key employees; changes in applicable laws or regulations; the inability of the Company to raise financing in the future; the inability of the Company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the inability of the Company to identify, in-license or acquire additional technology; the inability of the Company to maintain its existing or future license, manufacturing, supply and distribution agreements and to obtain adequate supply of its products; the inability of the Company to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently marketing or developing; 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 the Company’s products and services; the Company’s estimates regarding expenses, revenue, capital requirements and needs for additional financing; the Company’s financial performance; and other risks and uncertainties indicated from time to time in Company’s filings with the Securities and Exchange Commission, including those under “Risk Factors” therein. The Company cautions readers that the foregoing list of factors is not exclusive and that readers should not place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.

¹ https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices

View source version on businesswire.com: https://www.businesswire.com/news/home/20240717609854/en/

Media Contact

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Health+Commerce

shay@healthandcommerce.com

Investor Contact

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Gilmartin Group LLC

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Source: Hyperfine, Inc.

FAQ

What is the latest FDA clearance for Hyperfine's Swoop® system (HYPR)?

Hyperfine received FDA clearance for its ninth-generation AI-powered Swoop® system software, which significantly reduces scan times for brain imaging without compromising image quality.

How does the new Swoop® system software update benefit stroke diagnosis?

The software update enables faster image acquisition, potentially speeding up the diagnostic process in acute care settings. This is important for time-sensitive conditions like stroke, where rapid diagnosis can significantly impact treatment outcomes.

What is Hyperfine's position in AI-powered medical devices according to the FDA?

Hyperfine (HYPR) holds a leading position on the FDA's Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices list, demonstrating their commitment to leveraging AI in advancing portable MR brain imaging technology.

How does the new Swoop® system software update address patient motion issues?

By reducing overall acquisition time for sequences, the software update can decrease the negative impact of patient motion on image quality, potentially improving diagnostic accuracy.