
Hyperfine today announced FDA clearance of an entirely new portable MRI scanner powered by its proprietary Optive AI software. This new system delivers higher levels of image quality, functionality, and usability.
The new Swoop system is engineered to deliver the highest signal-to-noise ratio, which helps achieve improved image quality, including better resolution, uniformity, and faster acquisition times. It also delivers a user- and patient-centric design to accommodate a broad patient population—especially beneficial for pediatric, elderly, or anxious patients.
“This next-generation hardware and the Optive AI software platform begin a new chapter for the adoption of AI-powered portable MRI. This clearance is the most significant innovation in the history of Hyperfine. We plan to launch the new Swoop system across hospital and office settings in the U.S., and we believe the new Swoop system performance will delight patients and providers, reduce the learning curve for users, and drive meaningfully faster adoption,” said Maria Sainz, President and CEO of Hyperfine.
Collaboration with portable MRI programs, including Jefferson Abington, has accelerated the development of the new system.
The new Swoop system is being used in NEURO PMR, a Hyperfine-sponsored study examining the clinical utility of portable MRI in neurology offices. The two participating sites have reported positive feedback from both users and patients so far.
The new Swoop system accelerates Hyperfine's strategy to broaden adoption across a wide range of care environments, including critical care, emergency, and clinic settings in hospitals, neurology offices, and remote and rural care environments.