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Hyperfine Receives 510(k) Clearance from U.S. FDA for Swoop Portable MRI System

08/13/2020 | Business Wire
Hyperfine Research, Inc. has received 510(k) clearance from the US FDA for its category-defining portable MRI technology, the Swoop™ Portable MR imaging device. Hyperfine’s Swoop™ system is a point-of-care MR imaging device that wheels directly to the patient’s bedside, plugs into a standard electrical wall outlet and is controlled through a wireless tablet, making MR imaging accessible, immediate and seamless.
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