Hyperfine’s Image Assessment Software Captures FDA Clearance
Software provides annotated and segmented brain images captured by Hyperfine’s portable MRI system.
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.”
For more coverage based on industry expert insights and research, subscribe to the Diagnostic Imaging e-Newsletter here.
Newsletter
Stay at the forefront of radiology with the Diagnostic Imaging newsletter, delivering the latest news, clinical insights, and imaging advancements for today’s radiologists.
FDA Expands Approval of MRI-Guided Ultrasound Treatment for Patients with Parkinson’s Disease
July 9th 2025For patients with advanced Parkinson’s disease, the expanded FDA approval of the Exablate Neuro platform allows for the use of MRI-guided focused ultrasound in performing staged bilateral pallidothalamic tractotomy.
FDA Clears Virtually Helium-Free 1.5T MRI System from Siemens Healthineers
June 26th 2025Offering a cost- and resource-saving DryCool magnet technology, the Magnetom Flow.Ace MRI system reportedly requires 0.7 liters of liquid helium for cooling over the lifetime of the device in contrast to over 1,000 liters commonly utilized with conventional MRI platforms.
