Hyperfine’s Image Assessment Software Captures FDA Clearance

Hyperfine Research, Inc., secure 510(k) clearance from the U.S. Food & Drug Administration for its Advanced AI image assessment software that can automatically measure and return annotated and segmented brain images.

This software works with Hyperfine’s Swoop™ Portable MR Imaging System, the first MRI system develop to capture brain MRI images at the patient’s bedside. In particular, this tool offers ventricular volume, image extraction, alignment, and midline shift. This data gives providers of all expertise levels the quantitate markers that are necessary for decision support, as well as the immediate feedback that can be critical for diagnostic feedback.

“With this powerful tool now built into the Swoop™ system, we are making MR imaging not only accessible at the bedside, but making it easier for providers to move quickly from scan to a recommended course of treatment,” said Khan Siddiqui, M.D., Hyperfine’s chief medical officer. “The data provided by Hyperfine’s deep learning software will liberate users of our MR technology by providing simple, accessible information in just minutes.”

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