Hyperfine, Inc. Regulatory Clearances
United States
February 2020. Swoop® system. The world’s first bedside Magnetic Resonance Imaging (MRI) system for brain imaging of patients aged two and up. (US FDA K192002)
August 2020. Swoop system. For brain imaging of all patient ages. (US FDA K201722)
January 2021. BrainInsight™ automated AI tool. Provides measurements of brain structures, such as midline shift and lateral ventricular volume, from Swoop system T1 (Gray/White) and T2 axial images for patients ages eighteen years and older. (US FDA K202414)
July 2021. Swoop system. Additional automatic alignment and motion correction features. Automatic alignment provides images in standard anatomical orientation, regardless of the patient’s physical orientation. Motion correction detects and reacquires diffusion-weighted imaging (DWI) data if corrupted by motion. (US FDA K211818)
November 2021.Swoop system. Deep learning image reconstruction techniques that enhance the quality of T1, T2, and FLAIR images generated by a portable MRI system at a patient’s bedside. (US FDA K212456)
June 2022. Swoop system. Adds a new T1 (Standard) sequence optimized for imaging internal brain structures and a new Fast T2 sequence with a shorter scan time. (US FDA K221393)
July 2022. BrainInsight automated AI tool. Updated AI models for improved insights from Swoop system exams. (US FDA K220815)
December 2022. BrainInsight automated AI tool. Midline shift and lateral ventricular volume applications added for Fast T2 and FLAIR sequences. Expands patient population to patients two years and older for midline shift and lateral ventricular volume applications. (US FDA K223268)
December 2022. Swoop system. Improved DWI image quality due to increased signal-to-noise ratio. Expanded field of view for T1, T2, and FLAIR sequences. Retrained advanced reconstruction models. (US FDA K223247)
February 2023. Swoop system. Significantly improved DWI image quality and more robust compensation for subtle patient motion. Improved noise correction and uniformity correction for all sequences (US FDA K230208)
Canada
November 2021. The Swoop system approved for commercial sale in Canada. (Health Canada License 107054)
The BrainInsight automated AI tool is available for commercial sale in Canada.
Australia
February 2022. The Swoop system approved for commercial sale in Australia. (TGA ARTG Identifier 384545)
European Union
February 2023. The Swoop system approved for commercial sale in the European Union.
New Zealand
February 2022. The Swoop system notified to WAND database and available for commercial sale in New Zealand.
United Kingdom
November 2022. The Swoop system and the BrainInsight automated AI tool are approved for commercial sale in the United Kingdom. (UKCA 759579)
Big tech in a small package.
The Hyperfine Swoop system is the only portable MRI that can move to your patient's bedside at the point of care, plug into a standard electrical outlet, and acquire critical neuroimages within minutes. No waiting. No patient transport.
