Hyperfine has earned U.S. Food and Drug Administration (FDA) clearance for its next-generation Swoop portable MRI system, powered by its Optive AI software.

The company said the next-gen Swoop system incorporates knowledge from five years of real-world experience across every continent and numerous care settings. The new system has tools engineered to deliver the highest signal-to-noise ratio.

When paired with the Optive AI software—which earned an FDA nod last week—Hyperfine said the new system can achieve exceptional image quality with improve resolution, uniformity, and faster acquisition times.

The new Swoop system also features a user and patient-centric design to accommodate a wide population of patients. The company said it’s especially useful for pediatric, elderly, or anxious patients undergoing an MRI.

Collaboration with leading portable MRI programs, including Jefferson Abington, has accelerated the development of the new system. These strong clinical partnerships have helped shape hardware and software refinements critical to clinical utility.

“This sleek, innovative redesign of the Swoop system is a transformational advance for the emerging field of portable MR imaging,” noted Jennifer Villa Frabizzio, MD, Neuroradiologist at the Radiology Group of Abington. “It improves patient comfort by accommodating a broader range of body types and increases efficiency by allowing technologists to reach patients more quickly. But the real breakthrough lies in how the hardware and software work together to deliver image quality and speed, which brings portable MRI into the realm of mainstream clinical practice.”

Last month, the company began NEURO PMR, a Hyperfine-sponsored study examining the clinical utility of portable MRI in neurology offices. The company said that two participating sites have reported positive feedback from users and patients so far.

“This next-generation hardware and the Optive AI software platform begin a new chapter for the adoption of AI-powered portable MRI,” said Maria Sainz, president and CEO of Hyperfine. 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.”

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