FDA grants 510(k) clearance to Hyperfine Research’s MRI system

13 February 2020 (Last Updated February 13th, 2020 12:10)

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Hyperfine Research’s bedside Magnetic Resonance Imaging (MRI) system.

FDA grants 510(k) clearance to Hyperfine Research’s MRI system
Hyperfine’s point-of-care MRI wheels directly to the patient’s bedside, plugs into a standard electrical wall outlet, and is controlled via a wireless tablet. Credit: Businesswire.

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Hyperfine Research’s bedside Magnetic Resonance Imaging (MRI) system.

The world’s first bedside MRI system is a portable point-of-care device controlled using a wireless tablet such as Apple Ipad.

Hyperfine Research founder and chairman Jonathan Rothberg said: “Nearly six years ago, a dream to create a portable, affordable MRI system was born. We assembled an astounding team, and they took the 10 million-fold improvement in computing power since MRI was invented and the best of the billions invested in green electronics and built something astonishing, something disruptive.”

The Hyperfine system, which can be wheeled directly to the patient’s bedside, can be plugged into standard electrical wall outlets.

Compared to conventional MRI systems, Hyperfine system is 20x lower cost, consumes 35x lower power and has 10x lower weight.

Commenting on the FDA 510(k) clearance of the system, Hyperfine CEO Dr Khan Siddiqu said: “More than 40 years after its first use, MRI remains a marvel. Unfortunately, it also remains inaccessible. It’s time that MRI made the jump to point of need just like X-ray and ultrasound have before it.

“Going beyond that, nearly 90% of the world has no access to MRI at all. With the FDA’s decision, we are now ready to rewrite the rules of MRI accessibility.”

Hyperfine Research performed thousands of brain scans in developing the system, including those within investigational partnerships at New York-Presbyterian Brooklyn Methodist Hospital, Penn Medicine, Good Samaritan Hospital Long Island, Yale-New Haven University and Brown University.

The FDA 510(k) clearance approves the use of the system in head imaging for patients aged two years and older. The device will be available shipment in a few months.