Synaptive Medical received an FDA clearance for its slightly miniaturized and more-manageable MRI system, the second such device to receive the agency’s green light in as many months.
Though larger and less-portable compared to Hyperfine Research’s wheeled MRI system—which netted a clearance in February, and is made to be moved to and from a patient’s bedside—Synaptive’s Evry scanner is still designed for the point-of-care setting.
According to the company, it only requires 250 square feet of room, with four feet around the device for safety, and is light enough that it can be installed on any floor without structural reinforcements, rigging or cranes.
Though similar in shape to larger, traditional MRIs with its open-bore shape, the Evry system uses a weaker superconducting magnet, with a strength of 0.5 Tesla compared to the typical 1.5 or 3 Tesla ratings. This magnetic field is stronger than Hyperfine’s portable device, which uses a 0.06 Tesla magnet combined with low-powered radio waves to produce an image.
Both Synaptive and Hyperfine’s systems are made to scan the head, in cases such as the evaluation of stroke patients within an emergency department, or for imaging people in intensive care without transporting them the distance to a hardened facility.
The Toronto-based Synaptive previously received Health Canada approval for Evry in late February. Last December, the company raised $25 million U.S. in an equity investment round led by Linamar Corporation, which also signed on to a manufacturing agreement.