Hyperfine Announces European Launch with CE Approval
Hyperfine (Nasdaq: HYPR) has received CE approval for its latest generation of AI-powered Swoop® system software under European Medical Device Regulation. This milestone follows the initial CE certification in 2023 and enables broader European commercial expansion of their portable MR brain imaging system. The company has already established distribution partnerships in thirteen European countries, including the five major European markets. The latest software improvements focus on reducing scan times, which is important for time-sensitive conditions like stroke, and minimizing the impact of patient motion on image quality.
Hyperfine (Nasdaq: HYPR) ha ricevuto l'approvazione CE per la sua ultima generazione di software Swoop® system software alimentato dall'IA, in conformità con il Regolamento europeo sui dispositivi medici. Questo traguardo segue la certificazione CE iniziale del 2023 e consente una più ampia espansione commerciale in Europa del loro sistema portatile di imaging cerebrale MR. L'azienda ha già stabilito partnership di distribuzione in tredici paesi europei, inclusi i cinque principali mercati europei. I recenti miglioramenti software si concentrano sulla riduzione dei tempi di scansione, un aspetto cruciale per condizioni time-sensitive come l'ictus, e sulla minimizzazione dell'impatto del movimento del paziente sulla qualità delle immagini.
Hyperfine (Nasdaq: HYPR) ha recibido la aprobación CE para su última generación del software Swoop® system software impulsado por IA, bajo la Regulación Europea de Dispositivos Médicos. Este hito sigue a la certificación CE inicial en 2023 y permite una mayor expansión comercial en Europa de su sistema portátil de imagen cerebral por MR. La compañía ya ha establecido asociaciones de distribución en trece países europeos, incluidos los cinco principales mercados europeos. Las últimas mejoras del software se centran en reducir los tiempos de escaneo, lo cual es importante para condiciones sensibles al tiempo como el accidente cerebrovascular, y en minimizar el impacto del movimiento del paciente en la calidad de la imagen.
Hyperfine (Nasdaq: HYPR)는 유럽 의료기기 규정에 따라 AI 기반의 최신 Swoop® 시스템 소프트웨어에 대한 CE 승인을 받았습니다. 이 이정표는 2023년 최초의 CE 인증에 이어지며, 휴대용 MR 뇌 영상 시스템의 유럽 상업적 확장을 넓힐 수 있게 해줍니다. 회사는 이미 다섯 개 주요 유럽 시장을 포함하여 13개 유럽 국가에서 유통 파트너십을 구축했습니다. 최신 소프트웨어 개선점은 뇌졸중과 같은 시간에 민감한 상태에 중요한 스캔 시간을 줄이는 것과 환자의 움직임이 이미지 품질에 미치는 영향을 최소화하는 데 중점을 두고 있습니다.
Hyperfine (Nasdaq: HYPR) a obtenu l'approbation CE pour sa dernière génération de logiciel Swoop® system software alimenté par IA, conformément à la réglementation européenne sur les dispositifs médicaux. Ce jalon fait suite à la certification CE initiale en 2023 et permet une expansion commerciale plus large en Europe de leur système d'imagerie cérébrale par IRM portable. L'entreprise a déjà établi des partenariats de distribution dans treize pays européens, y compris les cinq principaux marchés européens. Les dernières améliorations logicielles se concentrent sur la réduction des temps de scan, ce qui est crucial pour des conditions sensibles au temps comme les AVC, ainsi que sur la minimisation de l'impact des mouvements des patients sur la qualité de l'image.
Hyperfine (Nasdaq: HYPR) hat die CE-Zulassung für seine neueste Generation der KI-gesteuerten Swoop®-Systemsoftware gemäß der europäischen Medizinprodukteverordnung erhalten. Dieser Meilenstein folgt auf die erste CE-Zertifizierung im Jahr 2023 und ermöglicht eine breitere kommerzielle Expansion in Europa für ihr tragbares MR-Gehirnbildgebungssystem. Das Unternehmen hat bereits Vertriebs partnerschaften in dreizehn europäischen Ländern etabliert, darunter die fünf wichtigsten europäischen Märkte. Die neuesten Softwareverbesserungen konzentrieren sich auf die Reduzierung der Scanzeiten, was für zeitkritische Erkrankungen wie Schlaganfälle wichtig ist, und auf die Minimierung der Auswirkungen von Patientenbewegungen auf die Bildqualität.
- CE approval received for latest AI-powered Swoop® system software in Europe
- Expanded distribution network across 13 European countries
- Software improvements reduce scan times for faster diagnosis
- Enhanced efficiency in emergency department settings
- None.
Insights
The CE approval for Hyperfine's enhanced Swoop® system software represents a significant market expansion opportunity in Europe. The approval under MDR (EU 2017/745) regulations, combined with established distribution partnerships in 13 European countries, positions the company for substantial revenue growth potential in the region.
The improved software's faster scan times address a critical market need in acute care settings, particularly for stroke diagnosis where time-to-treatment is crucial. This technological advancement could accelerate market adoption, especially given the system's unique portable design and lower cost compared to traditional MRI machines.
The company's strategic positioning in all five major European markets, coupled with the software improvements, could drive increased unit sales and recurring software revenue. However, investors should note that significant marketing investment and clinical validation will be needed to drive adoption in the conservative European healthcare market.
This regulatory milestone unlocks a market opportunity worth billions in the European medical imaging sector. The Swoop® system's value proposition of bringing MRI capabilities to diverse healthcare settings addresses a significant gap in the
The distribution network spanning 13 European countries provides immediate market access infrastructure, important for a small-cap company with resources. The AI-powered software improvements enhance the product's competitive positioning against traditional MRI manufacturers, potentially enabling faster market penetration and revenue generation.
CE approval of the latest generation Swoop® system software is a significant milestone in Hyperfine’s international strategy, allowing broader European commercial expansion.
The Swoop® Portable MR Imaging® System (Photo: Business Wire)
Hyperfine secured initial CE certification for the Swoop® system in 2023. Earlier this year, Hyperfine significantly expanded its global distribution network with partnerships established in thirteen European countries, including the five major European markets. This strategic expansion aims to enhance access to advanced portable brain MR imaging technology across diverse healthcare settings worldwide.
“We are thrilled to announce CE approval for the latest generation of AI-powered software for the Swoop® system, marking a pivotal step toward making advanced brain imaging technology accessible across the globe,” shared David Castiglioni, Hyperfine Chief Commercial Officer. “With a broad international distribution network in place and the latest software being CE-approved, we are well positioned for commercial expansion. We are committed to transforming healthcare through innovative, cost-effective solutions that address long-standing barriers to MRI access, and we look forward to expanding our collaboration with European healthcare leaders and providers to improve brain MRI access and patient outcomes across the region.”
The Swoop® System Software
Scan time reductions in the most recent software may enable Swoop® system images to help speed up the diagnostic process in professional 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.
“CE approval of the latest generation of Swoop® system software is an important advance in making rapid MR brain imaging accessible in emergency department settings across Europe,” shared Dr. Keith Muir of the University of
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
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 professional 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.
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Source: Hyperfine, Inc.
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