Hyperfine wins FDA clearance for updated portable MRI software

Hyperfine, Inc. (Nasdaq: HYPR) has received FDA clearance for a new version of its Optive AI software, which runs on the company's Swoop portable MRI system designed for brain imaging.

According to a press release from the Guilford, Connecticut-based company, this is the second FDA-cleared software package released since the Swoop system's next-generation launch in mid-2025. The updated software includes improved noise correction across all imaging sequences, a redesigned user interface with a guided scanning workflow, and the ability to view sequences and images during acquisition.

The update also introduces an isotropic T1 sequence, which delivers thinner slices and uniform resolution across imaging planes. The company said this capability may be useful in clinical situations such as post-operative tumor follow-up.

The Swoop system operates without electromagnetic shielding, allowing it to be used in intensive care units and emergency departments. Hyperfine said the noise cancellation improvements are intended to produce clearer images in such environments.

"This software is designed to improve performance today and is also architected for our ultra-low-field future," said Tom Teisseyre, Chief Operating Officer of Hyperfine, citing potential future applications including neurosurgery contrast imaging and quantitative MRI.

Hyperfine said it plans to begin rolling out the software to existing and new Swoop system users in the United States in September.

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