Healthcare technology firm Hyperfine Research has received U.S. Food and Drug Administration 510(k) clearance for its Swoop point-of-care MRI scanner.
Swoop is the latest generation of Hyperfine's portable MRI technology, which mounts an MRI scanner on wheels in a configuration that can be taken to a patient's bedside. The scanner plugs into a standard electrical wall outlet and can be controlled through a wireless tablet. Hyperfine believes its technology will make MRI more accessible and immediate.
The company points out that the new FDA clearance expands the company's clinical indication for brain imaging to include patients ages 0 to 2. The original version of the company's technology was cleared in February 2020.
Hyperfine said that Swoop is available for purchase and shipments will begin immediately.