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:
Platforms:
- 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
Facility:
- Amazon Web Services Hosting Facility (Data Center) managed by Amazon Web Services located in Ashburn, Virginia, United States of America
ISO 13485:2016
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.
SOC 2 Type II
Hyperfine, Inc. received a SOC 2 Type II report of the Swoop® Portable MR Imaging® system. The report, issued by the independent auditing firm Barnes Denig, attests to the effectiveness of Hyperfine, Inc. controls to meet the Trust Services Criteria for security. Customers and partners with an existing NDA may request a copy.
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.
