Hyperfine, Inc. (NASDAQ: HYPR), the company behind the world’s first FDA-cleared portable MRI system powered by artificial intelligence – the Swoop® system – has received FDA approval for its latest software innovation, Optive AI™. This marks the tenth major software update for the Swoop® system and represents a significant advancement in image quality for ultra-low-field MRI.
The new software uses AI to optimize every part of the imaging workflow, from noise reduction to final image reconstruction. The result is clearer, more detailed brain images with improved uniformity and anatomical precision.
Clinicians who tested the software at selected pilot sites earlier this year praised the improvements. Some even noted that the new image clarity approaches that of standard 1.5T MRI systems, highlighting the potential for better diagnostic accuracy.
“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’s Vice President of Technology.
Tom Teisseyre, Chief Operating Officer at Hyperfine, added: “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.”
The company expects to begin rolling out the new software to its customer base starting in Q3 2025.