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Hyperfine gets FDA nod for world's first portable bedside MR system

John R. Fischer, Senior Reporter | February 12, 2020

Dr. Kevin Sheth, senior author and chief physician of the division of neurocritical care and emergency neurology at Yale School of Medicine and Yale New Haven Hospital in Connecticut, told HCB News that he can see the system used frequently to assess "lots of acute neurological injuries, like head trauma and brain hemorrhages."

He adds that the next steps for further building up the technology are scanning more patients, improving image quality, using the devices in multiple settings and using machine learning to extract as much meaningful information as possible. "It's still early. We are in the process of imaging these pathologies when they are first presented to the emergency department."

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Ward says any next steps require the help of Hyperfine's collaborators. "Today is a major milestone for Team Hyperfine, but there's a lot more our current platform can do, so we are pursuing additional indications, working with our clinical research partners," said Ward. "We have ideas and active efforts on several fronts. And we need to achieve regulatory clearance in additional countries."

Hyperfine unveiled the system at the 2019 Radiological Society of North America and it will be on display once more at the International Stroke Conference in Los Angeles, from February 19-21; NVIDIA GPU Technology Conference in San Jose, from March 23-26; and at the American Society of Neuroradiology in Las Vegas from May 30 – June 4, 2020.

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