Point-of-Care MRI Secures FDA 510(k) Clearance

April 30, 2020

Superconducting head MRI approved for use in critical care environments.

Robotic surgical visualization company Synaptive Medical secured 510(k) clearance from the U.S. Food & Drug Administration today for Evry™, its superconducting, head MRI. The system is designed provide diagnostic imaging capabilities at the point-of-care in critical-care settings.

According to a company statement, Evry will be able detect potential COVID-19 complications, ischemic stroke, neurological damage, or potential head trauma. The system will soon be commercially available in the United States, and it will be operational both independently and with a variety of outside systems.

“As medical professionals, our goal is to utilize every tool at our disposal that will improve outcomes for our patients in a variety of situations,” said Gustavo Pradilla, M.D., chief of neurosurgery at Grady Memorial Hospital. “With the availability of Evry in the United States, we will now be able to provide critical diagnostic information in settings beyond where traditional MRIs are offered, which can significantly expedite the speed at which we make actionable decisions that positively impact patient care.”

Evry’s mid-field 0.5T superconducting magnet can be housed in a smaller apparatus than traditional higher-field MRIs, reducing the amount of floor space it takes up. It also include pre-defined imaging protocols, automated series planning, including volume selection, a detachable stretcher to support bedside transfers, and a multi-channel head coil with patient-specific customized fitting that can maximize image quality.

Additionally, as a smaller system, delivery is easier – there’s no need for rigging or cranes. Cost is also reduced, company officials said, because it doesn’t require yearly cryogen refills, a cryogen pipe, and reinforced flooring.