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)
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)
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)
October 2023. Swoop system. Adds advanced denoising for DWI image post-processing. Improved image quality for all sequences. (US FDA K232760)
July 2024. Swoop system. Significantly faster sequence scan times. New system quality control test features to support users with accreditation needs. (US FDA K240944)
Canada
November 2021. The Swoop system approved for commercial sale in Canada. (Health Canada License 107054)
Australia
February 2022. The Swoop system approved for commercial sale in Australia. (TGA ARTG Identifier 384545)
European Union*
February 2023. The Swoop system has CE certification for the European Union. (EC Certificate Number 28620144059)
*Not yet commercialized.
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 has UKCA certification for the United Kingdom. (UKCA 759579)
*Not yet commercialized.
The Swoop® system brings MR brain imaging within reach.
The Swoop system brings brain imaging within reach for clinicians to help them make clinical decisions in a variety of healthcare settings across a range of conditions. The first FDA-cleared portable MR brain imaging system that combines safe, ultra-low-field magnetic resonance with proprietary artificial intelligence, the Swoop system potentially enables timelier treatment decisions, quicker discharges, and more efficient use of staff and hospital resources.
