Hyperfine wins FDA nod to expand MRI image-sharpening AI

About two years after first introducing deep learning artificial intelligence technology capable of enhancing certain images captured by its MRI-on-wheels system, Hyperfine has now gotten the regulatory go-ahead to apply the AI to all of the Swoop system’s scans.

The new FDA clearance, which Hyperfine announced this week, adds the advanced image post-processing AI to the machine’s diffusion-weighted imaging (DWI) sequence. The deep learning tech had previously been greenlighted by the FDA for addition to its T1, T2 and FLAIR sequences in late 2021.

The latest nod marks Hyperfine’s eighth FDA clearance in the span of three years, CEO Maria Sainz noted in the announcement. The bedside MRI system was first cleared in 2020, and the host of regulatory OKs that have followed include a handful for other deep learning software upgrades, like one cleared in 2022 that added two new sequences to the Swoop system’s roster: a T1 sequence that can image structures deeper inside the brain tissue and a T2 sequence that’s 50% faster than the standard T2 offering.

The post-processing algorithm helps de-noise the images produced after the Swoop system performs a scan: It relies on brainlike artificial neural networks to clean up the images in small patches at a time, reducing blurring and other “noise” that could potentially lead to incorrect or missed diagnoses while preserving parts of the image that are critical to a diagnosis.

According to a Hyperfine white paper (PDF) discussing the use of the deep learning AI, the company’s algorithm has been proven to improve the image quality of T1, T2 and FLAIR images captured by the Swoop system by 60%, measured in terms of the scans’ signal-to-noise ratio.

The company will begin rolling out the updated Swoop software—now enabling the AI to be used for DWI images—in the coming months, according to this week’s release, where Tom Teisseyre, Hyperfine’s chief operating officer, added, “These imaging improvements will serve a critical role in enhancing image quality for healthcare professionals in time-sensitive environments.”

In another company upgrade announced this week, Hyperfine has promoted two members of its executive team.

Edmond Knopp, M.D., has been named vice president of medical affairs, putting him in charge of guiding clinical studies and working with medical professionals as he leads Hyperfine’s work to improve ultralow-field brain imaging. Knopp first joined Hyperfine at the start of 2021 as a senior medical director.

Chip Truwit, M.D., came aboard the company as another of its senior medical directors in early 2022. He’s now been named vice president of scientific affairs, a role that’ll see him leading clinical innovation projects at Hyperfine.

Both of the appointments will take effect immediately, according to Tuesday’s announcement.