Hyperfine Inc（HYPR）资讯与事件HYPRHyperfine Inc

Hyperfine Announces NEURO PMR Study Results

Hyperfine announced the peer-reviewed publication of the NEURO PMR study in the Journal of Neuroimaging. NEURO PMR, or Neurological Evaluation in the Office with Portable MR, is the first prospective, multicenter, real-world study to evaluate the clinical performance and patient experience of portable MRI compared with high-field MRI in outpatient neurology clinics. With respect to clinical performance, portable MRI demonstrated 92% concordance with high-field MRI in identifying the presence or absence of structural abnormality in blinded neuroradiology review, and 98% with clinical information. In addition, patients preferred portable MRI over high-field MRI by a four-to-one margin, rating it superior on all dimensions assessed in the study, including comfort, anxiety, claustrophobia, noise and overall experience.

Hyperfine Receives FDA Clearance for Optive AI Software Update

Hyperfine announced that it has received FDA clearance for its latest Optive AI software update. This advancement is Hyperfine's second FDA-cleared software package since the launch of its next-generation Swoop system in mid-2025. "This latest advancement reflects our commitment to frequent Optive AI software updates that continuously expand the clinical value of the Swoop system and provide our customers with access to the most advanced portable brain MRI technology available," said Tom Teisseyre, Chief Operating Officer of Hyperfine. "This software is designed to improve performance today and is also architected for our ultra-low-field future. Capabilities such as the new isotropic T1 sequence are particularly exciting because they demonstrate just how clinically valuable imaging at this field strength can be. We've also established a foundation for future potential applications such as neurosurgery contrast imaging and quantitative MRI, opening the door to additional sites of care for the Swoop system."

Hyperfine Q2 Revenue at $3.904M, Below Consensus

Reports Q2 revenue $3.904M, consensus $4.14M. "Q2 was another strong quarter for Hyperfine, marked by solid growth in placements and revenue, continued gross margin expansion, disciplined operating expense management, and a strengthened balance sheet. One year into the launch of the next-generation Swoop(R) system and our entry into the neurology office market, we are seeing broader use across care settings and international markets. We are executing on our strategy to expand MRI access across sites of care, increase the clinical utility of our technology, and broaden our international reach. With record U.S. scan volume, continued momentum across hospital and office settings, and international commercial progress, portable brain MRI is moving from early adoption toward broader mainstream clinical use," said Maria Sainz, Chief Executive Officer and President of Hyperfine, Inc.