World’s First Bedside MRI System Receives FDA 510(k) Clearance

February 12, 2020 — Hyperfine Research, Inc. announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the world’s first bedside Magnetic Resonance Imaging (MRI) system, clearing the way for device shipments this summer. The Hyperfine system is 20x lower cost, 35x lower power consumption, and 10x lower weight than today’s fixed conventional MRI systems.

“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, the best of the billions invested in green electronics and they built something astonishing, something disruptive,” said Jonathan Rothberg, Ph.D., founder and chairman of Hyperfine Research.