Notice of Intent to Sole Source Hyperfine Swoop MRI System Software and Maintenance

The National Institute of Standards and Technology (NIST) Acquisition Management Division intends to negotiate with Hyperfine Operations, Inc., located in Guilford, CT, on a sole source basis under the authority of FAR Subpart 13.106-1(b), soliciting from a single source, for software updates and maintenance on NIST’s Hyperfine Swoop Portable MRI System. Specific Requirements are as follows: Software & Firmware Support Licensing: Provide annual access to the Hyperfine cloud-based image reconstruction platform. Software: Operate system and obtain images in DICOM format. Updates: Deploy all software updates as available. Security: Ensure all software patches comply with NIST IT security requirements for networked laboratory equipment. Preventative Maintenance The Contractor shall perform two (2) scheduled PM visits per year . Each visit must include, at a minimum: Verification of the static magnetic field homogeneity. Testing and calibration of the Gradient Coils and RF chains. Mechanical inspection of the bridge, motor drives, and caster locking systems. Validation of the internal "Self-Shielding" electromagnetic interference (EMI) cancellation system. Replacement of high-wear items as defined by the OEM service manual. Bridge and Motor check. Corrective Maintenance (Repairs) Response Time: The Contractor shall provide phone/remote support within 4 business hours and on-site repair services within 48–72 hours of a service call. Parts: All replacement parts must be new, OEM-certified, and compatible with the Swoop MRI architecture. Coil Support: Maintenance and repair/replacement coverage for the 8-channel Head Coil and any specialized NIST-purchased coils. NAICS Code is 811210 – Electronic and Precision Equipment Repair and Maintenance, with a Size Standard of $34M. NIST anticipates negotiating and awarding a firm-fixed-price purchase order to Hyperfine Operations, Inc. for this requirement. Interested parties that can demonstrate they could satisfy the requirements listed above for NIST must clearly and unambiguously identify their capability to do so in writing on or before the response date for this notice. This notice of intent is not a solicitation. Information submitted in response to this notice will be used solely to determine whether competitive procedures could be used for this acquisition. If competitive procedures are not used it is estimated that an award will be issued by March 01, 2026. Any questions regarding this notice must be submitted in writing via email to [email protected]. All responses to this notice of intent must be submitted to [email protected] no later than the date and time provided herein this posting. JUSTIFICATION FOR OTHER THAN FULL AN OPEN COMPETITION: NIST currently utilizes the Hyperfine Swoop MRI system for imaging of reference objects (phantoms) and people to understand system variability and conduct research on human subjects. Comprehensive market research confirms that Hyperfine Operations, Inc., is the Original Equipment Manufacturer (OEM) and the sole provider of the proprietary software architecture required for the system's operation. Because the software is closed-source and protected by intellectual property rights, no third-party vendors can provide the necessary updates, security patches, or deep-learning reconstruction algorithm calibrations. Furthermore, Hyperfine is the only entity with the specialized diagnostic tools and certified technicians required to perform hardware maintenance without compromising the system's FDA-cleared performance specifications. Consequently, Hyperfine Operations, Inc. is the only source capable of satisfying the government’s requirement for continued operational integrity and data consistency.