Hyperfine Regulatory Clearances

US FDA Clearances

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 deep learning analysis software. These advanced artificial intelligence (AI) applications measure brain structure and pathology in images acquired by the Swoop system through tools featuring automatic measurement of ventricular volume, brain extraction, brain alignment, and midline shift—a clinical measure of brain injury. (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)

Health Canada License

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

Australian TGA Registrations

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

New Zealand MedSafe Notification

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

Pakistan

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

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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