Welcome to our dedicated page for HYPERFINE news (Ticker: HYPR), a resource for investors and traders seeking the latest updates and insights on HYPERFINE stock.
Hyperfine Inc (HYPR) pioneers accessible MRI technology through its groundbreaking Swoop® Portable MR Imaging System, transforming diagnostic capabilities in critical care and underserved settings. This page serves as the definitive source for verified news and announcements related to corporate developments, clinical milestones, and financial performance.
Investors and healthcare professionals will find timely updates on regulatory clearances, partnership agreements, quarterly earnings, and technological advancements. Our curated collection includes press releases about device deployments, peer-reviewed study results, and strategic initiatives driving portable MRI adoption.
Key coverage areas include Swoop system innovations, financial results analysis, leadership updates, and market expansion efforts. All content is rigorously verified to ensure accuracy and relevance for stakeholders evaluating HYPR's position in the medical imaging sector.
Bookmark this page for streamlined access to Hyperfine's latest progress in redefining bedside diagnostics through ultra-low-field MRI technology. Check regularly for objective reporting on developments impacting both clinical practice and long-term corporate strategy.
Hyperfine (NASDAQ: HYPR) has secured CE Mark and UKCA approval for its Optive AI™ software, expanding the global reach of its AI-powered imaging technology. The software enhances the Swoop® portable MRI system's image quality through advanced AI processing at multiple stages, from noise cancellation to post-processing.
The approval follows recent FDA clearance and enables deployment in European and UK markets starting Q4 2025. The software upgrade is compatible with first-generation Swoop® systems without hardware modifications, offering enhanced brain imaging capabilities for various clinical applications including stroke, pediatric care, and neurodegenerative conditions.
Hyperfine (Nasdaq: HYPR), creator of the first FDA-cleared AI-powered portable MR brain imaging system - the Swoop® system - announced its participation in two upcoming investor conferences. The company will present at the H.C. Wainwright Global Investment Conference on September 8, 2025, and the Lake Street Capital Markets Best Ideas Growth Conference on September 11, 2025.
During these events, management will discuss recent milestones including two major technology clearances, the launch of their next-generation Swoop® system with Optive AI™ software, new office business initiatives, hospital growth plans, and clinical evidence updates.
Hyperfine (NASDAQ:HYPR), creator of the Swoop® AI-powered portable MRI system, reported strong Q2 2025 results with revenues of $2.7M, up 26% sequentially. The company sold 8 Swoop® systems in Q2, increasing from 6 units in Q1, while gross margin improved 800 basis points to 49.3%.
Key achievements include FDA clearances for Optive AI™ software and next-gen Swoop® system, successful completion of neurology office pilot program, and enrollment of the 100th patient in the NEURO PMR study. The company's AI technology showed 100% sensitivity in detecting ARIA-E in Alzheimer's patients during Lecanemab therapy trials.
Management maintains 2025 revenue growth guidance of 10-20% over 2024 and expects reduced cash burn of $27-29M for 2025, a 27% improvement from 2024.
Hyperfine (Nasdaq: HYPR) has reached a significant milestone in its NEURO PMR study, enrolling 100 patients within just 16 weeks, ahead of the planned schedule. The study, conducted at DENT Neurologic Institute and Texas Neurology, evaluates the company's next-generation Swoop® system, an FDA-cleared AI-powered portable MRI system for brain imaging in outpatient settings.
The multi-center study compares portable ultra-low-field MRI with conventional high-field MRI in neurology offices, with results expected in early 2026. The company has strategically partnered with NeuroNet Pro, the largest U.S. association of independent neurology practices, to expand commercial adoption. The milestone follows Hyperfine's successful office pilot program, where early adopters implemented Swoop® systems and obtained reimbursement from CMS and private insurers.
Hyperfine (Nasdaq: HYPR) has announced the initiation of the PRIME (Portable Rapid Imaging for Medical Emergencies) study, enrolling its first patients at Yale School of Medicine. The study will evaluate the company's AI-powered Swoop® portable MRI system in emergency department settings.
The PRIME study expands upon the previous ACTION PMR study and will utilize the next-generation Swoop® system with Optive AI™ software, featuring enhanced image quality and sharper anatomical detail. The research aims to assess the technology's effectiveness as a triage tool for various brain-related emergency conditions in a Level 1 emergency department.
Led by Dr. Kevin Sheth and Dr. Adam De Havenon, the study focuses on addressing critical challenges in emergency departments, including patient boarding and limited MRI access. The initiative aligns with Hyperfine's strategy to drive commercial growth by demonstrating how portable MRI can improve clinical workflows and diagnostic access at the point of care.
Hyperfine (Nasdaq: HYPR), known for developing the Swoop® system - the first FDA-cleared AI-powered portable MRI system for brain imaging, has scheduled its Q2 2025 financial results announcement for August 13, 2025.
The company will host a conference call at 1:30 PM PT / 4:30 PM ET on the same day. Investors can access the live audio webcast and recording through Hyperfine's investor relations website. Participants are advised to register at least 15 minutes before the call.
Hyperfine (Nasdaq: HYPR) announced promising interim results from the CARE PMR study at the 2025 Alzheimer's Association International Conference. The study evaluated the company's Swoop® AI-powered portable MRI system for monitoring Alzheimer's patients receiving Lecanemab therapy.
The study of 31 Alzheimer's patients demonstrated 100% sensitivity in detecting ARIA-E (cerebral edema) when compared to clinical high-field MRI scans. The Swoop® system offers a potential solution to overcome barriers in MRI safety monitoring for amyloid-targeting therapies, providing an affordable, portable alternative at the point of care.
The research, funded by the Alzheimer's Association and American Society of Neuroradiology, suggests ultra-low-field MRI could serve as an effective triage tool, though high-field MRI may still be needed for comprehensive evaluation in some cases.
Hyperfine (NASDAQ: HYPR) announced significant progress in expanding the application of its Swoop® AI-powered portable MRI system for dementia care. The company highlighted two major developments: a new study at the University of Kansas Alzheimer's Disease Research Center exploring expedited dementia diagnosis, and upcoming data presentations at the 2025 Alzheimer's Association International Conference.
The University of Kansas study, led by Dr. Jeffrey Burns, introduces the Accelerated Clinical Evaluations for Alzheimer's Disease (ACE-AD) program, combining in-office MR imaging, cognitive testing, and blood biomarkers in a single nurse-led clinic visit. Additionally, researchers from Washington University School of Medicine will present interim results from the CARE PMR study evaluating Swoop® for ARIA-E monitoring.
The initiative aims to address the growing global dementia crisis, affecting over 57 million people worldwide, by improving accessibility to MRI technology in underserved and rural areas.
Hyperfine (NASDAQ:HYPR) has commenced the commercial launch of its Optive AI™ software for existing Swoop® portable MRI system customers. The FDA-cleared software, which received approval in May 2025, significantly enhances image quality through AI-powered improvements in noise cancellation, image acquisition, reconstruction, and post-processing.
The software upgrade is being rolled out to U.S. hospitals and neurology offices, with international availability in Canada, Australia, and New Zealand. Clinical feedback has been notably positive, with physicians reporting markedly improved resolution and faster FLAIR images, enabling expanded use beyond ICU to ER and outpatient settings.
The Optive AI™ software is fully compatible with first-generation Swoop® systems and requires no hardware modifications, allowing immediate access to next-generation image quality for current users.
Hyperfine (Nasdaq: HYPR) has announced its first commercial sales of the next-generation Swoop® Portable MR Imaging system, powered by Optive AI™ software. Two leading hospitals in the northeastern United States have purchased the units following recent FDA clearance, planning to deploy them in intensive care units and emergency departments.
The new Swoop® system features enhanced signal-to-noise ratio and, combined with Optive AI™ software, delivers improved image resolution, uniformity, and faster acquisition times. The system's patient-centric design makes it particularly suitable for pediatric, elderly, and anxious patients, advancing Hyperfine's mission to transform MRI accessibility.
FAQ
What is the current stock price of HYPERFINE (HYPR)?
What is the market cap of HYPERFINE (HYPR)?
