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