Hyperfine Reports on Growing Evidence for the Use of Swoop® System Images in Stroke Diagnosis Presented at the 2025 International Stroke Conference
Hyperfine (NASDAQ: HYPR) presented two significant studies at the 2025 International Stroke Conference demonstrating the effectiveness of their Swoop® system, an AI-powered portable MR brain imaging system, in stroke diagnosis. The ACTION PMR study, conducted across four leading institutions in the US and Europe, showed that physicians using Swoop® system images could diagnose 90% of acute infarcts compared to conventional high-field MRI.
Research from Ohio State University and Massachusetts General Hospital demonstrated the system's ability to differentiate between stroke and stroke mimics, with strong agreement to high-field MRI results. The study highlighted faster time-to-scan compared to conventional MRI and good specificity in emergency stroke care. The ACTION PMR study, which began in July 2023, included one hundred patients and has shown substantial agreement between Swoop® system diagnoses and standard-of-care imaging in detecting acute ischemic strokes.
Hyperfine (NASDAQ: HYPR) ha presentato due studi significativi alla Conferenza Internazionale sugli Stroke del 2025, dimostrando l'efficacia del loro sistema Swoop®, un sistema di imaging cerebrale MRI portatile alimentato dall'IA, nella diagnosi degli ictus. Lo studio ACTION PMR, condotto in quattro importanti istituzioni negli Stati Uniti e in Europa, ha mostrato che i medici che utilizzavano le immagini del sistema Swoop® erano in grado di diagnosticare il 90% degli infarci acuti rispetto alla MRI convenzionale ad alto campo.
La ricerca della Ohio State University e del Massachusetts General Hospital ha dimostrato la capacità del sistema di differenziare tra ictus e ictus imitatori, con un'ottima concordanza rispetto ai risultati della MRI ad alto campo. Lo studio ha evidenziato un tempo di scansione più rapido rispetto alla MRI convenzionale e una buona specificità nella cura degli ictus in emergenza. Lo studio ACTION PMR, iniziato a luglio 2023, ha incluso cento pazienti e ha mostrato una sostanziale concordanza tra le diagnosi del sistema Swoop® e le immagini standard nella rilevazione degli ictus ischemici acuti.
Hyperfine (NASDAQ: HYPR) presentó dos estudios significativos en la Conferencia Internacional del Ictus 2025 que demuestran la efectividad de su sistema Swoop®, un sistema de imágenes cerebrales MR portátil potenciado por IA, en el diagnóstico de ictus. El estudio ACTION PMR, realizado en cuatro instituciones líderes en EE.UU. y Europa, mostró que los médicos que utilizan imágenes del sistema Swoop® podían diagnosticar el 90% de los infartos agudos en comparación con la MRI convencional de alto campo.
Investigaciones de la Universidad Estatal de Ohio y del Hospital General de Massachusetts demostraron la capacidad del sistema para diferenciar entre ictus y sus simuladores, con una fuerte concordancia respecto a los resultados de la MRI de alto campo. El estudio destacó un tiempo de escaneo más rápido en comparación con la MRI convencional y una buena especificidad en la atención de emergencia para ictus. El estudio ACTION PMR, que comenzó en julio de 2023, incluyó a cien pacientes y mostró una concordancia sustancial entre los diagnósticos del sistema Swoop® y las imágenes estándar en la detección de ictus isquémicos agudos.
Hyperfine (NASDAQ: HYPR)는 2025년 국제 뇌졸중 회의에서 Swoop® 시스템, 인공지능 기반의 휴대용 MR 뇌 이미징 시스템의 뇌졸중 진단 효과를 입증하는 두 가지 중요한 연구 결과를 발표했습니다. 미국과 유럽의 네 개의 주요 기관에서 진행된 ACTION PMR 연구에 따르면, Swoop® 시스템 이미지를 사용하는 의사들이 급성 경색의 90%을 기존의 고자기장 MRI와 비교하여 진단할 수 있음을 보여주었습니다.
오하이오 주립대학교와 매사추세츠 종합병원의 연구는 뇌졸중과 뇌졸중 모사체를 구분하는 시스템의 능력을 입증했으며, 고자기장 MRI 결과와 강한 일치를 보였습니다. 이 연구는 기존 MRI와 비교하여 더 빠른 스캔 시간을 강조했으며, 응급 뇌졸중 치료에서 높은 특이성을 보여주었습니다. 2023년 7월에 시작된 ACTION PMR 연구는 100명의 환자를 포함하였으며, Swoop® 시스템 진단과 표준 진료 이미징 간의 상당한 일치를 보여주었습니다.
Hyperfine (NASDAQ: HYPR) a présenté deux études importantes lors de la Conférence Internationale sur les AVC de 2025, démontrant l'efficacité de leur système Swoop®, un système d'imagerie cérébrale par IRM portable alimenté par l'IA, pour le diagnostic des AVC. L'étude ACTION PMR, réalisée dans quatre établissements de premier plan aux États-Unis et en Europe, a montré que les médecins utilisant des images du système Swoop® pouvaient diagnostiquer 90% des infarctus aigus par rapport à l'IRM conventionnelle à haut champ.
Une recherche de l'Université d'État de l'Ohio et de l'Hôpital Général du Massachusetts a démontré la capacité du système à différencier entre les AVC et leurs imitateurs, avec une forte concordance avec les résultats de l'IRM à haut champ. L'étude a souligné un temps de scan plus rapide comparé à l'IRM conventionnelle et une bonne spécificité dans les soins d'urgence pour les AVC. L'étude ACTION PMR, qui a débuté en juillet 2023, a inclus cent patients et a montré une concordance substantielle entre les diagnostics du système Swoop® et l'imagerie de référence pour la détection des AVC ischémiques aigus.
Hyperfine (NASDAQ: HYPR) hat auf der International Stroke Conference 2025 zwei bedeutende Studien präsentiert, die die Wirksamkeit ihres Swoop®-Systems, eines tragbaren MR-Hirnbildgebungssystems, das von KI unterstützt wird, bei der Schlaganfalldiagnose demonstrieren. Die ACTION PMR-Studie, die an vier führenden Einrichtungen in den USA und Europa durchgeführt wurde, zeigte, dass Ärzte, die Swoop®-Systembilder verwendeten, 90% der akuten Infarkte im Vergleich zur konventionellen Hochfeld-MRI diagnostizieren konnten.
Forschungen von der Ohio State University und dem Massachusetts General Hospital demonstrierten die Fähigkeit des Systems, zwischen Schlaganfällen und deren Nachahmungen zu unterscheiden, mit starker Übereinstimmung zu den Hochfeld-MRI-Ergebnissen. Die Studie hob die schnellere Scanzeit im Vergleich zur konventionellen MRI und eine gute Spezifität in der Notfallversorgung bei Schlaganfällen hervor. Die ACTION PMR-Studie, die im Juli 2023 begann, umfasste einhundert Patienten und zeigte eine erhebliche Übereinstimmung zwischen den Diagnosen des Swoop®-Systems und der Standardversorgung in der Erkennung akuter ischämischer Schlaganfälle.
- 90% accuracy rate in diagnosing acute infarcts compared to conventional MRI
- Faster time-to-scan performance compared to conventional MRI
- Strong agreement with high-field MRI in stroke detection
- Successfully completed clinical study with 100 patients across four major institutions
- None.
Insights
The clinical validation presented at ISC 2025 marks a pivotal moment for Hyperfine's commercialization strategy. The 90% diagnostic accuracy in acute infarct detection compared to traditional high-field MRI represents a breakthrough in portable imaging technology, potentially disrupting the $30 billion global MRI market.
Several key factors make this development particularly significant for investors:
- The successful completion of the ACTION PMR study across prestigious institutions provides the clinical validation necessary for broader market adoption and potential insurance reimbursement pathways.
- The demonstrated faster time-to-scan compared to conventional MRI addresses a critical bottleneck in stroke care, where time-to-treatment directly impacts patient outcomes.
- The system's ability to accurately differentiate between strokes and mimics could reduce unnecessary treatments and associated costs, making it attractive to healthcare systems focused on value-based care.
The market implications are substantial. With stroke being a leading cause of disability and death globally, a portable, AI-powered solution could revolutionize care delivery in various settings, from emergency departments to smaller hospitals lacking traditional MRI capabilities. The technology's validation in stroke diagnosis could accelerate market penetration and potentially lead to expanded applications in other neurological conditions.
Looking ahead, these clinical results could catalyze several growth drivers:
- Increased adoption in emergency departments seeking to optimize stroke care protocols
- Expansion into underserved markets where traditional MRI access is
- Potential new revenue streams through AI-based diagnostic services and software updates
Two presentations at ISC build on a growing body of data demonstrating the value of AI-powered portable MR images in providing information to aid physicians in the diagnosis of acute ischemic stroke, including data from the ACTION PMR stroke study.
The AI-powered Swoop® portable MR brain imaging system. (Photo: Business Wire)
Ohio State University, an ACTION PMR site, presented its data* from the study showing that physicians were able to use Swoop® system images to diagnose 90 percent of acute infarcts seen on conventional high-field MRI—the standard of care—and also demonstrated DWI-FLAIR mismatch, a key method of identifying acute ischemic stroke. Researchers from Massachusetts General Hospital also presented data* on stroke detection, showing that images from the Swoop® system enabled accurate differentiation of stroke versus stroke mimics with strong agreement to high-field MRI, indicating the Swoop® system’s value in evaluating patients with suspected stroke and transient ischemic attack.
The ACTION PMR study is a prospective, international, multi-site observational study that aims to examine the value and role of brain imaging with the Swoop® portable MR brain imaging system in acute ischemic stroke diagnosis and treatment. Enrollment in the study is complete with one hundred patients at four leading institutions in the US and Europe—the University at Buffalo, the University of
ACTION PMR data has been presented at multiple leading conferences throughout the study progression, including the Radiological Society of
Taylor Kimberly, MD, PhD, of Massachusetts General Hospital, the study’s principal investigator, commented, “Since ACTION PMR launched in July 2023, my colleagues and I have seen very promising results indicating that portable, ultra-low-field MR imaging can be a valuable tool for stroke detection and triage. The demonstration of accurate lesion detection validates the feasibility of this technology as an accessible, scalable alternative to conventional imaging.” He continued, “The improved time to imaging compared to conventional MRI could facilitate quicker decision-making in acute stroke management, which could lead to the implementation of more effective treatments and help to facilitate better patient outcomes.”
Maria Sainz, Hyperfine, Inc. President and CEO, adds, “The ACTION PMR study shows that the Swoop system has the potential to activate a paradigm shift in stroke diagnosis and treatment all over the world. By combining cutting-edge AI with portability, we empower healthcare providers with critical diagnostic imaging that can change the course of treatment in acute care settings such as the emergency department. As we move forward with additional clinical studies, we are honored to work with distinguished clinical investigators and stroke advisors to gather further evidence on how the Swoop® system can make brain imaging faster and more accessible in emergency settings.”
For more information about the Swoop® Portable MR Imaging® system, please visit hyperfine.io.
*Data available upon request.
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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Media
Devin Zell
Hyperfine
dzell@hyperfine.io
Investor
Webb Campbell
Gilmartin Group LLC
webb@gilmartinir.com
Source: Hyperfine, Inc.
FAQ
What accuracy rate did the Swoop system achieve in detecting strokes according to the 2025 ISC presentation?
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