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- Hyperfine's PRIME study demonstrated that the Swoop portable MRI system reduced median time from imaging order to scan start from 7.76 hours to 1.28 hours in emergency departments. - The FDA-cleared portable brain MRI system weighs 1,400 pounds, operates via tablet guidance, and requires no specialized MRI personnel or dedicated rooms. - AIIMS New Delhi became the first hospital in India to deploy the Swoop system for routine clinical use, marking expansion into international markets. - The technology addresses critical barriers in neuroimaging access for stroke, trauma, and ICU patients where conventional MRI transport is unsafe or impractical.
- Hyperfine has enrolled the first patient in the Contrast PMR study, a multi-center clinical trial evaluating contrast-enhanced ultra-low-field portable MRI to support FDA 510(k) submission for expanded use. - The study will assess visualization benefits of gadolinium-based contrast agents with the Swoop® system across approximately 70 patients, focusing on brain lesions and blood-brain barrier disruption. - The company anticipates submitting to the FDA for indication expansion by the end of 2026, potentially unlocking new applications for brain tumors, abscesses, and inflammatory conditions like multiple sclerosis. - This development follows recent FDA clearance of advanced diffusion imaging capabilities and publication of clinical data demonstrating stroke detection capabilities with the portable MRI system.
- Hyperfine's Optive AI software received FDA clearance, representing the most significant improvement to date in image quality for the company's Swoop portable MRI system. - Early users at select clinical sites reported image quality approaching that of conventional 1.5T MRI scanners, a notable achievement for an ultra-low-field portable device. - The tenth-generation software utilizes advanced AI algorithms to enhance every stage of brain imaging from noise reduction to post-processing, resulting in clearer and more anatomically detailed images. - Hyperfine plans to begin rollout in Q3 2025, with expectations that this advancement will support expanded hospital adoption and entry into neurology clinics.
