Hyperfine, Inc.

Hyperfine Advances International Swoop System Model 2 Rollout and Highlights the Role of Portable MRI in Brain Health Awareness

Hyperfine received CE mark and UKCA approvals for its latest Optive AI software update, supporting the international rollout of the Swoop system Model 2 portable MRI. Within months of its mid-2026 European launch, Model 2 has achieved sales across four international markets including the UK, France, and Romania. The company is also showcasing the Swoop system in Germany's Notes and Neurons brain-health initiative, highlighting an emerging non-clinical growth avenue.

•10d ago

Hyperfine Reports Record Preliminary Third Quarter Revenue of Approximately $6.0 Million & Reaffirms Full Year 2026 Revenue Outlook of Approximately $20 to $22 Million

Hyperfine announced preliminary unaudited Q3 2026 revenue of approximately $6.0 million, a record representing 53% sequential growth over Q2. Preliminary quarterly revenue exceeded net cash burn (~$5.6 million, a 29% sequential improvement) for the first time, and cash stood at approximately $37.9 million at quarter end with no financing raised in Q3. Management reaffirmed FY2026 guidance of $20-22 million in revenue (~55% growth at midpoint) and $26-28 million net cash burn; complete results come with the November 9 earnings call.

•24d ago

Hyperfine Expands Global Access to Portable Brain MRI Technology Across Key Gulf Cooperation Council Healthcare Markets

Hyperfine appointed Roots Pharmaceutical Co. W.L.L. as exclusive distributor of the Swoop portable MRI system for Kuwait and the United Arab Emirates. Roots will handle market development, local regulatory activities, product education, and, following any applicable regulatory clearances, commercial and service activities across both countries. The deal is an incremental step in Hyperfine's international growth strategy but carries no disclosed financial terms, and GCC revenue remains contingent on pending regulatory clearances.

•1mo ago

Hyperfine Announces Completion of Enrollment in the Contrast PMR Study to Support the Submission to Expand Indications for Use of the Swoop® System with Contrast Agents

Hyperfine completed enrollment in its Contrast PMR study, a prospective, multi-center clinical study evaluating contrast-enhanced ultra-low-field brain imaging with the Swoop portable MRI system and commonly administered gadolinium-based contrast agents. The study is intended to support the first expansion of the Swoop system's indications for use since its original FDA clearance, with a planned FDA 510(k) submission by the end of 2026. CEO Maria Sainz framed contrast-enhanced imaging as an adoption catalyst, citing established reimbursement pathways and new use cases in outpatient neurology and post-procedural imaging, including assessment of residual tumor after resection.

•1mo ago

Lioness Medtech Showcasing Hyperfine Swoop at Röntgenveckan 2026

Nordic medtech distributor Lioness Medtech is showcasing Hyperfine's Swoop portable MRI with live brain scans at Röntgenveckan 2026, the Swedish radiology conference in Gothenburg running September 8-11. The showcase follows Hyperfine's recent CE Marking of the next-generation Swoop system and Optive AI software, which covers the European Economic Area and supports point-of-care brain imaging without RF shielding. Lioness Managing Director Bernt Nordin called the CE approvals highly encouraging for the European market, citing strong potential in acute and critical care settings where bedside imaging beats transporting patients to a fixed MRI suite.

•1mo ago

Hyperfine Builds Momentum in Year One of Neurology Office Launch with NEURO PMR Publication and More Than 3,000 Scans

Hyperfine announced the peer-reviewed publication of the NEURO PMR study in the Journal of Neuroimaging, which demonstrated 92% concordance with high-field MRI and a 4-to-1 patient preference for its Swoop portable system. The company reported completing more than 3,000 brain MRI scans in the first year of its neurology office-market launch, signaling early adoption across diverse outpatient practices. Management highlighted that the Swoop system is expanding access to brain imaging beyond hospitals, supporting a shift toward proactive and efficient neurological care models.

•2mo ago

Hyperfine Announces FDA Clearance of the Next Optive AI™ Software, Further Enhancing Image Quality, Clinical Utility, and Ease of Use of the Swoop® System Across Care Settings

Hyperfine received FDA clearance for its Next Optive AI software, which improves image quality and ease of use for the Swoop portable MRI system. The update introduces a new isotropic T1 sequence for three-dimensional visualization and advanced noise cancellation for challenging environments like ICUs. Rollout to existing and new U.S. customers is scheduled to begin in September, following the mid-2025 launch of the next-generation system.

•2mo ago

Hyperfine, Inc. Reports Second Quarter 2026 Financial Results

Hyperfine reported Q2 revenue of $3.9 million, up 44.8% year-over-year, driven by a 50% increase in commercial system placements to 12 units. Gross margin improved to 50.7% and the net loss per share narrowed to $0.09 from $0.12 in the prior year, supported by disciplined expense management. The company ended the quarter with $43.5 million in cash and reaffirmed full-year 2026 revenue guidance of $20 million to $22 million, representing 55% growth at the midpoint.

•2mo ago

Hyperfine Announces the Release of Multiple Peer-Reviewed Publications, Expanding Clinical Evidence for the Swoop® System Across a Growing Number of Sites of Care

Hyperfine announced new peer-reviewed publications in the Journal of Neurosurgery and Stroke that support the clinical utility of its Swoop portable MRI system in neurosurgical and stroke care settings. The cited evidence suggests the system can facilitate same-day discharges by providing immediate post-procedural imaging, expanding its value proposition beyond critical care into emergency departments and stroke centers. The company now boasts more than 180 peer-reviewed publications and over 280 scientific presentations, marking a transition toward broader routine clinical use.

•3mo ago

New Yale Study Shows Portable MRI Cuts Time to Brain Imaging by 80% in the Emergency Department

Results from the PRIME study at Yale New Haven Health showed Hyperfine's Swoop system reduced the median time from imaging order to scan start by 6.35 hours, representing approximately 80% faster access compared to conventional MRI. The randomized controlled trial of 100 adult ED patients reported a median scan time of 1.28 hours for the portable MRI cohort versus 7.76 hours for the standard of care cohort. CEO Maria Sainz noted that rapid enrollment signaled the high frequency of MRI need as a triage tool in emergency departments.

•3mo ago

Peer-Reviewed Study Demonstrate Significant Economic and Operational Benefits of Portable MRI in Acute Hospital Care

A peer-reviewed health economics study published in Clinical Neuroimaging validated the economic and operational benefits of Hyperfine's Swoop Portable MR Imaging System in acute care settings. The retrospective analysis of 143 scans found a median reduction in MRI turnaround time of 18.4 hours per patient, with an average cost reduction of $590 per scan and up to four hours of clinical labor saved per scan. The study also reported a 385% increase in scans completed within five hours of order placement, indicating the system's ability to improve diagnostic access and workflow efficiency in ICUs and emergency departments.

•3mo ago

Hyperfine Announces European Launch of Next-Generation Swoop® System

Hyperfine initiated the European commercial launch of its next-generation Swoop system, known as Model 2, following the receipt of CE mark and UKCA approvals. The system, powered by the latest Optive AI software, has been included in the UniHA procurement listing, enabling broader adoption across the French public healthcare system. Management highlighted this launch as a key milestone for 2026 commercialization, planning to expand availability through distribution partners to all represented European markets by year-end.

•4mo ago

Hyperfine Forms Global Neurosurgery Advisory Council to Support Expansion of Portable MRI in Neurosurgical Care

Hyperfine established a Neurosurgery Advisory Council composed of leading surgeons to guide the application of the Swoop portable MRI system in surgical care. Council members from institutions including Johns Hopkins and the University of Toronto will advise on clinical evidence, product development, and workflow integration. The initiative aims to overcome limitations of traditional MRI in the operating room by improving access to imaging for better decision-making.

•4mo ago

Hyperfine Swoop® System Scan Volume in the United States Hits Record Milestones Across Multiple Sites of Care

Hyperfine announced record scan volume milestones for its Swoop portable MRI system, highlighting accelerating clinical adoption across US hospitals and neurology clinics. Jefferson Abington Hospital surpassed 1,000 scans to become the highest volume center, while CHRISTUS Mother Frances reached the 500-scan milestone in nine months and purchased a second system for a satellite emergency department. The company noted expanding use cases in operating rooms and outpatient settings, citing evidence of cost savings and a 4:1 patient preference for portable MRI.

•4mo ago

Hyperfine to Join Russell 2000® and Russell 3000® Indexes

Hyperfine is expected to join the Russell 2000 and Russell 3000 indexes following the June 2026 reconstitution, effective after market close on June 26, 2026. The inclusion reflects the company's market capitalization ranking among the 4,000 largest U.S. stocks as of April 30, 2026, and signals growing institutional recognition. CEO Maria Sainz stated that the inclusion reflects progress in executing the commercial strategy and driving adoption of the Swoop portable MRI system.

•5mo ago

Hyperfine Announces Presentation of Results from the PRIME Study Showing Portable MRI Substantially Reduces Time to Imaging in Emergency Departments

Hyperfine presented results from the PRIME study at the SAEM 2026 Annual Meeting, showing that its portable Swoop MRI system reduced median time to imaging by 6.35 hours compared to conventional MRI in emergency departments. The prospective randomized trial enrolled 100 patients and found that 18.6% of scans revealed critical pathology, such as acute ischemic stroke, which was successfully detected by the portable system. Management highlighted the potential for portable MRI to alleviate ED boarding and improve diagnostic efficiency, reinforcing the clinical value proposition of the Swoop system.

•5mo ago