Hyperfine has earned U.S. Food and Drug Administration (FDA) clearance for its tenth-generation software for ultra-low-field MR imaging, Optive AI.

Optive AI enhances the imaging process with noise cancellation, image acquisition and reconstruction, and post-processing. The company said this results in brain images with more clarity, uniformity, and sharper anatomical detail.

Hyperfine rolled out the software at select clinical sites earlier this year. The company said users were enthusiastic, with some reporting the image quality is approaching conventional 1.5T MRI scanners.

Hyperfine’s VP of technology Rafael O’Halloran said the software released is the beginning of a transformative era for the company.

The advanced AI algorithms integrated into our new software platform dramatically elevate image quality at ultra-low field strength, enabling more confident diagnoses at the point of care,” O’Halloran told the press. “We previewed Optive AI software at the recent American Society of Neuroradiology annual meeting and received outstanding feedback. It’s the strongest signal yet of where we’re headed—and how far AI-powered portable MRI imaging can go.”

The company plans to begin Optive AI’s rollout to accounts in the third quarter of this year.

“Optive AI software is our tenth software release since initial FDA clearance and marks a critical inflection point in the evolution of Swoop system technology—the first of two major technology milestones we have been looking forward to this year,” said Tom Teisseyre, Hyperfine’s COO. “The significant image quality enhancements enabled by Optive AI software will serve as a catalyst for our 2025 growth strategy, supporting expansion into new hospital sites of care and our entry into the neurology office market.”

Last month, the company began the observational NEURO PMR (Neurological Evaluation in the Office with Portable MRI) study to compare portable ultra-low-field MRI and conventional high-field MRI with respect to pathology findings, clinical utility, and patient experience.