Hyperfine scores EU approval of portable MRI system, setting up possible global expansion

Hyperfine has gotten the green light to take its talents to the EU—but whether the portable MRI tech maker will actually make the transatlantic trip is another story.

The Connecticut-based company landed CE mark authorization for its Swoop imaging system, it announced Tuesday. Though that allows the MRI-on-wheels to be used throughout the European Economic Area, Hyperfine said in the announcement that, at least for the rest of 2023, it intends to keep its focus on the U.S. market.

But the devicemaker didn’t completely count out a future EU expansion, noting in the release that it remains an option, with that particular door now propped open by the CE mark approval.

The Swoop system, equipped with permanent magnets and low-power radio waves, is designed to be rolled throughout a hospital directly to the bedsides of patients who aren’t able to use a traditional MRI scanner. Once plugged into a standard wall outlet, the machine churns out high-quality scans of a patient’s brain, controlled by a wirelessly connected tablet.

The system was cleared by the FDA in 2020 and has also received authorizations for use in Canada, Australia, the U.K. and more.

In the EU, the CE mark approval certifies that Hyperfine’s technology meets the “significantly more stringent” guidelines of the continent’s somewhat controversial new Medical Device Regulation, CEO Maria Sainz said in the company’s announcement.

“Receiving CE marking for our portable MRI system with AI-powered imaging software is a significant achievement for our company and enables opportunities for future geographic expansion beyond our current commercial focus in the United States,” Sainz said.

Since scoring its initial FDA clearance and launching the Swoop system stateside about three years ago, Hyperfine has racked up a handful of additional regulatory clearances from the agency to bulk up the system’s software platform.

One such add-on, for example, was cleared by the FDA last summer. It tacked on two more MRI sequences to the software and enables the machine to perform its brain scans in as few as three minutes. Another FDA nod doled out at the end of 2021 added deep-learning artificial intelligence technology to the system, which Hyperfine said could make the resulting scans less blurry and improve image quality by up to 60%.

Most recently, earlier this month, the regulator signed off on improvements to the Swoop system’s AI software that aim to expand the scanner’s field of view and further improve the image quality specifically of its diffusion-weighting imaging sequence.