FDA Approves New Superconducting MRI Technology

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Evry, a point-of-care head MRI system designed to provide immediate access to diagnostic imaging for patients in need for emergency care.

The approval allows Synaptive Medical to move forward with the superconducting, head MRI technology that can be particularly useful for detecting potential complications from the coronavirus disease 2019 (COVID-19), ischemic stroke, neurological damage or potential head trauma.

The device features a mid-field 0.5T superconducting magnet that is small enough to reduce the footprint currently allotted to MRI machines. Evry also includes predefined imaging protocols, automated series planning including volume section, a detachable stretcher to support bedside transfers and a multichannel head coil with patient-specific customized fitting intended to optimize image quality.

Because of its small size, Evry can be delivered without cranes and forgoes yearly cryogen refills, a cryogen pipe and reinforced flooring, providing significant cost-savings for healthcare 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, Gustavo Pradilla, MD, Chief of Neurosurgery, Grady Memorial Hospital, said in a statement. “With the availability of Evry in the US, 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.”

All of Synaptive’s products, including Evry, can be used independently or with outside systems.