Hyperfine’s Bedside MRI System Nabs 510(k) Clearance
The FDA granted Hyperfine Research 510(k) clearance for its portable bedside magnetic resonance imaging (MRI) system.
The device can be wheeled to a patient’s bedside and plugs directly into a standard electrical wall outlet. It is controlled using a wireless tablet, such as an iPad.
The system weighs less than conventional MRI systems and uses less power. The company plans to launch the devices commercially this summer.