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Hyperfine gets FDA nod for deep learning, image reconstructive tech

by John R. Fischer, Senior Reporter | November 30, 2021
Artificial Intelligence MRI

Back in September, Ohio State University Wexner Medical Center became the first in its home state to deploy Swoop for the diagnosis of brain injuries. Two are now operating in the provider’s emergency room and Comprehensive Stroke Center operating room. It also is used in Yale New Haven Hospital, UCI Medical Center and the University of Illinois and Chicago's Surgical Innovation Training Lab (SITL).

“There is no question this device can help save lives in resource-limited settings, such as rural hospitals or developing countries,” said Kevin Sheth, professor of neurology and neurosurgery at Yale School of Medicine and co-corresponding author of the research, back in September.

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The company also announced in July that it would go public by merging with Liminal Sciences and HealthCor Catalio Acquisition Corp. into one company with a total enterprise value of approximately $580 million. All three plan to develop solutions together across the care continuum that will expand the existing $23 billion global imaging market, particularly for MR and brain sensing technologies.

Hyperfine is currently working on getting Health Canada approval, U.K. CA mark, European CE mark, and regulatory approval in Australia and New Zealand for its advanced image reconstructive technology.

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