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, Inc. (Nasdaq: HYPR) announced promising interim findings on the value of its Swoop® Portable MR Imaging® system for acute stroke care at the 2024 European Society of Neuroradiology Annual Meeting. The study, presented by Dr. Keith Muir of the University of Glasgow, compared the ultra-low-field Swoop® system to conventional MRI and head CT in emergency stroke workup.
Key findings include:
- Faster time-to-scan: 2.5 hours median for Swoop® vs. 27.7 hours for conventional MRI
- Comparable diagnostic performance to head CT
- Good specificity compared to 1.5T MRI
- Positive patient experience reported
The study concludes that the portable ultra-low-field MRI system shows promise in enhancing stroke diagnosis accessibility and efficiency, particularly where conventional MRI availability is
Hyperfine, Inc. (Nasdaq: HYPR) has announced a collaboration with the Medical University of South Carolina to assess astronaut brain health using the Swoop® Portable MR Imaging® system. The research will focus on the Polaris Dawn mission, acquiring brain images of astronauts before and after spaceflight. The study aims to assess intracranial volume changes and gain insights into spaceflight-associated neuro-ocular syndrome (SANS).
Dr. Donna Roberts, the principal investigator, emphasized the importance of understanding how human physiology adapts to spaceflight and zero-gravity environments. The Swoop® system will capture MR brain images of the four Polaris Dawn crewmembers at key points: seven days before launch, within hours of return, and one day after return. This research could provide valuable data on intracranial venous congestion during spaceflight and brain re-adaptation to Earth.
Hyperfine (Nasdaq: HYPR), the company behind the first FDA-cleared portable MR brain imaging system, announced its participation in upcoming investor conferences. Management will present at the H.C. Wainwright 26th Annual Global Investment Conference on September 9, 2024, at 7:00 am ET. They will also host in-person meetings at the 2024 Wells Fargo Healthcare Conference in Boston on September 5th, 2024.
A live webcast of the H.C. Wainwright event and an archived recording will be available on the company's website. The webcast will be accessible for at least 90 days after the event. Hyperfine's groundbreaking Swoop® system has redefined brain imaging with its portability and FDA clearance.
Hyperfine, Inc. (HYPR) reported record quarterly revenue of $3.63 million in Q2 2024, up 7.4% year-over-year. The company achieved a 50% gross margin and sold 13 commercial Swoop® systems. Hyperfine raised its FY 2024 revenue guidance to $13-16 million, reflecting 31% growth at the midpoint. Key achievements include FDA clearance of 9th generation AI-powered brain imaging software and initiation of the CARE PMR study for Alzheimer's patients. The company expanded internationally, appointing distributors in 12 EU markets and India. Despite progress, Hyperfine reported a net loss of $10.16 million for Q2 2024, slightly improved from $10.64 million in Q2 2023.
Hyperfine (Nasdaq: HYPR) presented initial data from observational clinical studies evaluating the use of its Swoop® Portable MR Imaging® system for Alzheimer's patients at the 2024 Alzheimer's Association International Conference (AAIC). The CARE PMR study, involving multiple sites, assesses the clinical utility of Swoop® images in detecting amyloid-related imaging abnormalities (ARIA) in patients receiving amyloid-targeting therapy.
Key findings include:
- Evidence of ARIA-E detection in one patient using low-field strength imaging
- Strong agreement between low-field and high-field MR images in brain morphometry evaluation
- Potential for portable MRI to transform Alzheimer's disease management across various care settings
Hyperfine (Nasdaq: HYPR) has received FDA clearance for its ninth-generation AI-powered Swoop® system software, significantly reducing scan times for brain imaging without compromising image quality. This advancement positions Hyperfine as a leader in AI-powered health technology, potentially speeding up diagnoses in acute care settings, particularly for time-sensitive conditions like stroke. The software update may also help mitigate the impact of patient motion on image quality.
Professor Adnan Siddiqui from the University of Buffalo highlighted the importance of this development for stroke diagnosis workflows. Hyperfine's commitment to AI innovation is evident in its leading position on the FDA's AI/ML-Enabled Medical Devices list. Tom Teisseyre, Chief Operating Officer at Hyperfine, emphasized the company's focus on balancing speed and image quality to inform better patient care decisions in acute settings.
Hyperfine (Nasdaq: HYPR) highlights results from a multi-site study demonstrating the value of its Swoop® Portable MR Imaging® System in acute stroke diagnosis. The study, to be published in the August 2024 issue of Annals of Neurology, shows promising results for using Swoop® system images to assess stroke patients and guide critical treatment decisions. The study included 71 patients and was conducted by teams from Massachusetts General Hospital and the University at Buffalo.
This publication marks the first to include a subset of data from the ACTION PMR stroke study, which has already enrolled over 100 patients at four institutions. The study aims to compare stroke detection capabilities between ultra-low-field MRI, conventional high-field MRI, and CT. A workflow phase evaluating the Swoop® system's ease of access and versatility in emergency departments and stroke centers is set to begin later this year.
Hyperfine is set to announce its second-quarter 2024 financial results on August 8, 2024. The company, known for its FDA-cleared portable MR brain imaging system, the Swoop system, will host a conference call at 1:30 p.m. PT / 4:30 p.m. ET. The call will be accessible via a live audio webcast on the Investors page of Hyperfine's corporate website. Participants are encouraged to register at least 15 minutes early.
Hyperfine (Nasdaq: HYPR), a leading health technology company, announced new distribution partnerships in Germany, Austria, Switzerland, and Nordic markets for its FDA-cleared portable MR brain imaging system, the Swoop®. This strategic move expands Hyperfine's reach to twelve European countries, complementing previous agreements in France, the UK, and Italy. The Swoop® system, known for its affordability, accessibility, and high performance, aims to enhance brain imaging services globally. Hyperfine's strong track record in securing international approvals supports its commercial growth, with plans for further expansion into Asian markets, including India.
Hyperfine (Nasdaq: HYPR) has announced the acceptance of two presentations on the clinical utility of their portable ultra-low-field MRI system, Swoop®, for Alzheimer's disease monitoring at the 2024 Alzheimer’s Association International Conference, from July 28 to August 1 in Philadelphia. These presentations, prepared by clinicians from Washington University, Massachusetts General Hospital, and Yale University, will focus on the use of the Swoop® system for detecting and monitoring treatment efficacy in Alzheimer's patients. Hyperfine aims to make brain imaging more accessible and affordable, enhancing care in diverse settings. The company is also conducting the CARE PMR study to evaluate the system's utility in detecting amyloid-related imaging abnormalities (ARIA) in patients undergoing amyloid-targeting therapy.