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. (Nasdaq: HYPR) is a health technology and medical device company that focuses its news flow on developments around the Swoop® Portable MR Imaging® System, an FDA-cleared, portable, ultra-low-field brain MRI platform. Company press releases emphasize regulatory milestones, clinical studies, financial results, and global health initiatives tied to this AI-powered portable MRI technology.
Investors and clinicians following HYPR news can expect regular updates on clinical research and indication expansion efforts. Recent announcements include the enrollment of the first patient in the Contrast PMR study, a prospective, multi-center trial designed to evaluate contrast-enhanced ultra-low-field portable MRI to support a future FDA submission for expanded intended use of the Swoop® system with gadolinium-based contrast agents. Other clinical news has highlighted the PRISM PMR study, which evaluates the Swoop® system’s use in neurosurgical operating room settings, and a peer-reviewed publication describing the economic impact of integrating the Swoop® system into acute hospital care.
Hyperfine’s news feed also features regulatory and market access updates, such as regulatory approval of the Swoop® system in India by the Central Drugs Standard Control Organization (CDSCO), as well as CE Mark and UKCA Mark approvals for its Optive AI™ software. Financial and corporate news includes quarterly and preliminary unaudited financial results, capital raises through public offerings, participation in healthcare conferences, and business updates related to the commercial rollout of the next generation Swoop® system and Optive AI™ software.
For those tracking HYPR, the news stream provides insight into the company’s progress in hospital and neurology office adoption, its international expansion, and its collaborations on global brain health projects such as the UNITY initiative. Bookmarking this page allows readers to monitor how Hyperfine’s clinical, regulatory, and financial developments evolve over time.
Hyperfine (Nasdaq: HYPR) published the largest dataset to date on stroke detection with the Swoop® portable MRI, a prospective multi-center observational study of 95 patients published in Stroke: Vascular and Interventional Neurology. The next-generation Swoop with an advanced multi-directional DWI sequence detected lesions as small as 2.8 mm (0.15 mL), achieved 100% sensitivity and 100% specificity for lesions >1.0 mL, and reduced scan time by approximately 30%. The advanced DWI sequence was recently cleared by the FDA. Systems were provided under sponsored research agreements; the company was not involved in study design, analysis, or publication decisions.
Hyperfine (Nasdaq: HYPR) announced NEURO PMR study results presented January 16, 2026 showing the portable Swoop® MRI (0.064T) has high diagnostic concordance and superior patient experience in outpatient neurology clinics.
In a prospective, multi-center real-world study of 125 patients at two sites, portable MRI showed 92% blinded concordance with standard MRI for detecting intracranial pathology and 98% concordance in unblinded reviews with clinical history. Patients were 4× more likely to choose portable MRI and rated it superior across comfort, anxiety, claustrophobia, noise, and overall satisfaction (p<0.0001). Trained clinic staff operated Swoop without MR technologists, and scans are eligible for reimbursement under existing brain MRI CPT codes after site accreditation.
Hyperfine (Nasdaq: HYPR) announced enrollment of the first patient in the Contrast PMR study, a prospective, multi-center trial to test contrast-enhanced ultra-low-field portable MRI using the Swoop system. The study will enroll approximately 70 patients across U.S. sites and will evaluate three endpoints related to visualization of brain lesions, including those tied to blood-brain barrier disruption. The trial is intended to support a future FDA 510(k) submission to expand the Swoop system's intended use to include gadolinium-based contrast agents, with a potential submission anticipated toward the end of 2026.
ClinicalTrials.gov identifier: NCT07296263. More information at HyperfineMRI.com.
Hyperfine (Nasdaq: HYPR) reported preliminary, unaudited Q4 2025 revenue of approximately $5.3M, +127% year-over-year and +54% sequentially, and preliminary full-year 2025 revenue of approximately $13.5M, +5% year-over-year. Preliminary Q4 2025 net cash burn excluding financings was ~$5.7M and preliminary full-year 2025 net cash burn was ~$29.9M, down 30% and 22% versus prior periods, respectively. Preliminary cash and cash equivalents were approximately $35.1M as of December 31, 2025. The company cited record Q4 placements, product launches, and expansion into neurology offices and international markets, and will release audited results and 2026 outlook on its March 2026 earnings call.
Hyperfine (Nasdaq: HYPR) announced a peer‑reviewed Clinical Neuroimaging publication showing economic benefits of the Swoop® AI‑powered portable MRI in acute hospital care.
A 12‑month retrospective analysis of 143 patients at Jefferson Abington Hospital found the Swoop system eliminated MR‑compatible equipment costs (averaging $590 per patient) and reduced MRI wait times by an average of 18 hours for ICU and ED patients, driving measurable cost avoidance and throughput improvements that could translate to tens to hundreds of thousands of dollars in annual savings depending on utilization.
Hyperfine (Nasdaq: HYPR) announced regulatory approval from India’s Central Drugs Standard Control Organization (CDSCO) for the Swoop® portable brain MRI system on December 17, 2025, authorizing commercialization across India.
The company said it will distribute Swoop in partnership with Radiosurgery Global (RSG) and plans a commercial launch in early 2026. The release highlights Swoop’s portability, lower infrastructure needs, and suitability for remote or lower-resource settings to expand access to brain imaging for conditions such as stroke, traumatic brain injury, and neurodegenerative disease.
Hyperfine (NASDAQ: HYPR) announced FDA clearance on December 15, 2025 for the first Optive AI™ software update: a multi-direction diffusion-weighted imaging (DWI) sequence for the Swoop® portable MRI system. The sequence acquires and averages signals from multiple directions to produce cleaner, more consistent diffusion images, improving sensitivity for smaller strokes and specificity for true infarcts. The existing single-direction DWI remains available for faster imaging in ultra-urgent stroke protocols. The update is available for all Swoop system models and is positioned to expand the system's clinical role in acute neurological and hospital care settings.
Hyperfine (Nasdaq: HYPR) will present at the Piper Sandler 37th Annual Healthcare Conference on Thursday, December 4, 2025 at 8:10 AM ET. The company, maker of the FDA-cleared AI-powered portable brain MRI Swoop®, will provide a live audio webcast with an archived recording available on its investor website. Management will hold in-person one-on-one meetings; investors should contact their Piper Sandler representative or the company’s investor contact to schedule.
Hyperfine (Nasdaq: HYPR) received a $3.7 million Gates Foundation grant to expand AI-powered portable neonatal MRI work through 2028. Funding will accelerate AI pipelines and technical innovation for the Swoop® portable MRI to evaluate infant neurodevelopment in resource-constrained settings as part of the UNITY project led by King’s College London.
The UNITY consortium spans >40 centers across low-, middle-, and high-income countries and has performed >10,000 examinations, including scans of >6,000 babies across five continents; the grant targets improved image clarity and diagnostic reliability for neonatal scans.
Hyperfine (Nasdaq: HYPR) reported third quarter 2025 results and a business update on November 13, 2025. Q3 revenue was $3.4M, up 27% sequentially, with 8 commercial Swoop systems sold (5 next generation). Gross margin was a record 53.8% ($1.8M), up 450 basis points QoQ. Net loss was $11.0M ($0.14/share), compared with $9.2M in Q2; the quarter included a $2.3M fair-value change on warrant liabilities.
Company launched next generation Swoop and Optive AI, expanded into neurology offices, obtained CE Mark and UKCA for Optive AI, raised $20.1M in October, and guided Q4 2025 revenue to $5–$6M and FY2025 revenue to $13–$14M.