FDA Clearance builds upon recent approval by Health Canada
Toronto, Canada [April 30, 2020] – Synaptive Medical, a leader in robotic surgical visualization, announced today the company has secured clearance from the Food and Drug Administration (FDA) for its superconducting, head magnetic resonance imaging (MRI) technology, Evry™. Synaptive developed Evry to provide medical professionals with diagnostic imaging capabilities directly at the point of care in critical care settings, which was unachievable until recently with commercially available MRIs.
Among Evry’s features include a mid-field 0.5T superconducting magnet that reduces the system’s physical footprint, as well as predefined imaging protocols, automated series planning, including volume selection, a detachable stretcher to support bedside transfers and a multichannel head coil with patient-specific customized fitting intended to optimize image quality. Evry also bypasses the need for rigging and cranes for the delivery of MRI, yearly cryogen refills, a cryogen pipe and reinforced flooring, thus providing significant cost advantages.
“We are thrilled to now offer Evry in both Canada and the U.S.,” said Cameron Piron, president and co-founder of Synaptive Medical. “Our mission at Synaptive has always been to offer unparalleled technologies that help improve and streamline how medical professionals deliver care to patients in a variety of acute and long-term settings. Securing clearance for Evry in the U.S., which follows closely on the heels of our recent approval in Canada, provides further validation of our approach as we continue to pursue addressing the needs of patients globally.”
Gustavo Pradilla, M.D., Chief of Neurosurgery, Grady Memorial Hospital, stated, “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. With the availability of Evry in the U.S., 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 can be used independently and with a variety of outside systems. However, when combined, the company’s product suite empowers healthcare professionals to fully optimize the quality and delivery of their services.
About Synaptive Medical
Synaptive Medical Inc., a Toronto-based medical device and technology company, designs hardware and software technologies that cross traditional barriers in hospitals and improve patient care in and beyond the operating room. Synaptive’s Modus V™ and integrated BrightMatter™ solutions—including surgical planning, navigation and visualization, and an informatics platform—give leading clinicians and healthcare systems the information they need to ensure the best possible outcomes for patients.