Home » Hyperfine’s Bedside MRI System Nabs 510(k) Clearance
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.
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