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Hyperfine Regulatory Clearances

United States

February 2020. The world’s first bedside Magnetic Resonance Imaging (MRI) system, specifically for brain imaging of patients aged two and up. (US FDA K192002)

August 2020. For brain imaging of all patient ages. (US FDA K201722)

January 2021. BrainInsight cloud-based automatic artificial intelligence (AI) solution. These AI applications can automatically measure imaging biomarkers in images acquired by the Swoop® system, featuring measurements of ventricular volume and midline shift. (US FDA K202414)

July 2021. Additional automatic alignment and motion correction features to the Swoop Portable MR Imaging System. Automatic alignment provides images in standard anatomical orientation, regardless of the patient’s physical orientation. Motion correction detects and reacquires diffusion-weighted images (DWI) data if corrupted by motion. (US FDA K211818)

November 2021. 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. Adds a new T1 (Standard) sequence optimized for imaging inside the brain and a new Fast T2 sequence with a shorter scan time. (US FDA K221393)

July 2022. BrainInsight updated AI models for improved insights from Swoop exams. (US FDA K220815)

Canada

November 2021. Swoop approved for commercial sale in Canada. (Health Canada License 107054)

BrainInsight is available for commercial sale in Canada.

Australia

February 2022. Swoop approved for commercial sale in Australia. (TGA ARTG Identifier 384545)

New Zealand

February 2022. Swoop notified to WAND database and available for commercial sale in New Zealand. (New Zealand MedSafe Notification)

Pakistan

April 2021. Swoop is commercially available for sale in Pakistan.

United Kingdom

November 2022. Swoop and BrainInsight are approved for commercial sale in the United Kingdom. (UKCA 759579)

Hyperfine Swoop COB

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.

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