FDA Clears ‘World’s First’ Portable, Low Cost MRI following Positive Clinical Research

by Matt O’Connor, writer, HealthImaging.com, moconner@healthimaging.com

Magnetic resonance imaging is no longer confined to radiology departments. On April 15, the US Food and Drug Administration officially provided clearance to the “world’s first” bedside MRI system.

Connecticut-based Hyperfine said it will begin shipping its portable, low field modalities this summer. The machine’s 510(k) FDA clearance was granted as Yale researchers reported accurate and safe results from tests involving brain readings of stroke victims. Those preliminary results will be presented at the American Stroke Association’s International conference in Los Angeles, the company said.

“We’ve flipped the concept from having to get patients to the MRI to bringing the MRI to the patients,” said Kevin Sheth, MD, senior author and a chief physician at Yale School of Medicine. “This early work suggests our approach is safe and viable in a complex clinical care environment.”

The study included 85 stroke patients who underwent bedside MRI within seven days of experiencing symptoms. A majority of individuals completed the exam, which took an average of 30 minutes. Six experienced claustrophobia and a few couldn’t fit into the machine, but there were no adverse events.

According to Hyperfine, their machine will cost $50,000, 20 times cheaper than traditional systems. It runs on 35 times less power and weighs 10 times less than normal 1.5T MRI machines.

The FDA clearance includes head imaging for patients two years and older and could help bring the modality to underserved areas such as rural settings and remote villages, explained Sheth, who added they’ve “cracked the door open” on bringing this technology to any region.

Sheth also noted that his team will perform further research using this device—built around a 0.064 Tesla magnet—to scan more patients, improve image quality and even employ machine learning to extract vast amounts of its novel imaging data.

For Jonathan Rothberg, PhD, who founded Hyperfine in 2014 and now chairs the company, the goal of revolutionizing how doctors think about MRI is now a reality. “Nearly six years ago, a dream to create a portable, affordable MRI system was born,” he said in a statement. “We assembled an astounding team, and they took the 10 million-fold improvement in computing power since MRI was invented, the best of the billions invested in green electronics, and they built something astonishing—something disruptive.”