Hyperfine, Inc. Certifications
HITRUST r2 RISK-BASED 2-YEAR
Based upon representation from management as to the accuracy and completeness of information provided, the procedures performed by an Authorized External Assessor to validate such information, and HITRUST’s independent confirmation that the work was performed in accordance with the HITRUST® Assurance Program requirements, the following platforms, facility, and supporting infrastructure of the Organization ("Scope") meet the HITRUST CSF® v9.4 Risk-based, 2-year (r2) certification criteria:
- Swoop® System Device Services residing at Amazon Web Services Hosting Facility
- Security Services residing at Amazon Web Services Hosting Facility
- Hyperfine, Inc. PACS Services residing at Amazon Web Services Hosting Facility
- BrainInsight™ Automated AI Tool Services residing at Amazon Web Services Hosting Facility
- Amazon Web Services Hosting Facility (Data Center) managed by Amazon Web Services located in Ashburn, Virginia, United States of America
The Hyperfine, Inc. Quality Management System is certified by Intertek as conforming to the requirements of ISO 13485:2016 for the design and development, manufacture, and service of Magnetic Resonance Imaging (MRI) devices, Picture Archiving Computer Systems (PACS), and software for the area of radiology.
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.