Hyperfine Receives FDA Clearance of Optive AI Software

May 29, 2025 — Hyperfine, Inc., producer of the world’s first FDA-cleared AI-powered portable MRI system for the brain — the Swoop system — has announced FDA clearance of its next-generation software.

This tenth-generation release delivers a substantial increase in image quality for ultra-low-field MR imaging. Optive AI software enhances each stage of the imaging process   — from noise cancellation and image acquisition to reconstruction and post-processing. The result is brain images with greater clarity uniformity, and sharper anatomical detail. These advanced AI algorithms are applied across all sequences.

Earlier this year, Hyperfine released the software at select clinical sites where early users responded enthusiastically to the image quality improvements, with some reporting that image quality is approaching that of conventional 1.5 tesla MRI scanners. This feedback underscores the clarity and consistency of the new images that can enhance patient care.

“This software release marks the beginning of a transformative era for Hyperfine. 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. 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,” said Rafael O’Halloran, Hyperfine Vice President of Technology.

“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. 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,” said Tom Teisseyre, Hyperfine Chief Operating Officer.

Hyperfine plans to initiate the rollout of Optive AI software to accounts in the third quarter of 2025.

For more information about the Swoop AI-powered portable MRI system, please visit hyperfine.io.