OEM News

Hyperfine Wins FDA Clearance for Next Optive AI Software

The update builds on Optive AI with improved image quality, a simplified scanning experience, and a new 3D imaging sequence.

Hyperfine has obtained U.S. Food and Drug Administration (FDA) clearance for the latest iteration of its Optive AI software for its Swoop portable brain MRI system.

The Guilford, Connecticut-based company’s latest software package is its second FDA-cleared release since the next-generation Swoop system launched in mid-2025. The update builds on Optive AI with improved image quality, a simplified scanning experience, and a new 3D imaging sequence, expanding the Swoop system’s clinical applications.

“This latest advancement reflects our commitment to frequent Optive AI software updates that continuously expand the clinical value of the Swoop system and provide our customers with access to the most advanced portable brain MRI technology available,” said COO Tom Teisseyre.

Because Swoop doesn’t require conventional MRI shielding, it can perform scans in electromagnetically noisy settings like ICUs and emergency departments. The software update improves noise correction across imaging sequences for clearer, more consistent images in point-of-care settings.

It also adds a guided scanning workflow and real-time image viewing to simplify operation. A new isotropic T1 sequence provides thinner slices and consistent resolution across imaging planes, supporting applications like follow-up for post-operative tumors.

“This software is designed to improve performance today and is also architected for our ultra-low-field future,” said Teisseyre. “Capabilities such as the new isotropic T1 sequence are particularly exciting because they demonstrate just how clinically valuable imaging at this field strength can be. We’ve also established a foundation for future potential applications such as neurosurgery contrast imaging and quantitative MRI, opening the door to additional sites of care for the Swoop system.”

Hyperfine intends to begin release of the new software in the U.S. to new and current Swoop users in September.


The company recently released promising results from its PRIME study of portable MRI in neurological emergencies. Learn more here!

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