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) will report full third quarter 2025 financial results on Thursday, November 13, 2025. Management will host a conference call at 1:30 p.m. PT / 4:30 p.m. ET with a live audio webcast and archived recording available on the company Investors page.
Participants are encouraged to register at least 15 minutes before the call. The company notes its FDA-cleared AI-powered portable brain MRI, the Swoop system, and directs users to HyperfineMRI.com for product information.
Hyperfine (Nasdaq: HYPR) announced that the PRISM PMR study has enrolled its first patients to evaluate the Swoop® portable MRI system in the neurosurgical operating room.
PRISM PMR (PRe- and post-operatIve Study of iMaging with Portable MR) will collect real-world data over three months at Atlas Surgery Center in Buffalo, NY, led by principal investigator Dr. Elad Levy. The study will assess pre- and post-procedure imaging across diverse neurosurgical procedures, detection of post-operative complications (stroke, bleeding), and workflow integration to support faster discharge and recovery.
Hyperfine (Nasdaq: HYPR) priced a registered underwritten public offering of 14,000,000 Class A shares at $1.25 per share, with gross proceeds to the company of approximately $17.5 million before fees. The underwriter has a 30-day option to purchase up to 2,100,000 additional shares (15% of the offering) at the same public price less underwriting discounts.
The offering is expected to close on or about October 17, 2025, subject to customary closing conditions. Lake Street Capital Markets is sole book-runner. Proceeds are intended for working capital and general corporate purposes, including commercial, manufacturing, and R&D. The securities are offered under an effective Form S-3 shelf registration.
Hyperfine (Nasdaq: HYPR) announced on October 15, 2025 that it has commenced an underwritten public offering of its Class A common stock or, for certain investors, pre-funded warrants to purchase Class A common stock. The company said all securities will be sold by Hyperfine and that underwriters will have a 30-day option to buy up to 15% of the total securities on the same terms. The offering is subject to market and other conditions and may not be completed.
Lake Street Capital Markets is sole book-runner. The securities are offered from an effective Form S-3 shelf registration (filed Nov 9, 2023; declared effective Nov 22, 2023). Final terms will be disclosed in a prospectus supplement filed with the SEC.
Hyperfine (Nasdaq: HYPR) reported preliminary, unaudited Q3 2025 results and business progress following the launch of the next generation Swoop system and Optive AI software. Preliminary Q3 revenue is expected to be ~$3.4M (sequential +27%); preliminary effective average device selling price is ~$360,000 (sequential +36%).
In Q3, 5 of 8 commercial Swoop systems sold (63%) were next generation units. Preliminary cash burn was ~$5.9M (sequential -27%), with preliminary cash and cash equivalents of ~$21.6M as of September 30, 2025. The company began office-setting launches and Optive AI rollout to installed base in US, Canada, Australia, and New Zealand.
Hyperfine (NASDAQ: HYPR) distribution partner UpCare Europe won a UniHA national referencing to supply the Swoop® AI-powered portable MRI system to France’s public hospitals. The framework covers procurement access for more than 1,500 public hospitals and 130 regional hospital groups and is effective November 2, 2025. The agreement allows Swoop® purchases over a three-year period and is the first inclusion of portable brain MRI in the UniHA framework. The release also notes recent CE marking of Hyperfine’s Optive AI software. The arrangement removes the need for individual tenders, streamlining adoption and enabling broader deployment of portable brain imaging across France.
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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.