Hyperfine Inc (NASDAQ: HYPR) is a medical device company that develops and sells the Swoop portable MRI system, a low-field, point-of-care magnetic resonance imaging device cleared by the FDA in 2020. Revenue comes from hardware sales of the Swoop system to hospitals and, increasingly, outpatient neurology offices, paired with recurring service and support contracts that include software upgrades, technical assistance, and access to a cloud-based PACS image viewer. The company sells direct in the United States through its own sales and field support organization, and has begun commercializing in Canada, select European and Middle Eastern markets, Australia, New Zealand, and India. Hyperfine was founded in 2014 by Dr. Jonathan Rothberg and is headquartered in the United States. As of February 15, 2026, the company employed 102 full-time staff, with 24 in sales, marketing, and commercial support and 56 in research, development, and operations. The Swoop system carries CE Mark, UKCA Mark, FDA 510(k) clearance, and regulatory authorizations in multiple international markets.
- Revenue model
- Hyperfine generates revenue through hardware sales of the Swoop portable MRI system and recurring service and support contracts. The service contract bundles technical assistance, software upgrades, and access to the Hyperfine Image Viewer cloud PACS platform. The company has not disclosed the specific revenue split between hardware and service in the provided filing excerpts.
- Products and services
- The Swoop portable MRI system is the sole commercial product. It is a 1,400-pound, low-field MRI device with a powered drive system enabling bedside and room-to-room use within hospitals. The ninth-generation system runs Optive AI software, which received FDA clearance for image quality improvements including motion artifact reduction. The system integrates with hospital IT infrastructure and PACS, or alternatively with Hyperfine's own cloud PACS. IAC accreditation standards published in November 2024 enabled CMS reimbursement for Swoop scans in outpatient neurology offices, opening an addressable market of nearly 2,400 potential U.S. locations per the FY2025 10-K filing.
- Customers and end markets
- Primary customers are U.S. hospitals and hospital systems, initially focused on critical care units and emergency departments, with expansion into hospital-based neurology clinics. A neurology office market launch occurred in mid-2025, targeting accredited outpatient neurology practices eligible for CMS and private-payer reimbursement. International customers include hospitals in Canada, Europe, the Middle East, Australia, New Zealand, and India.
- Value-chain role
- Hyperfine designs, manufactures, sells, and services the Swoop portable MRI system. It operates as a vertically integrated medical device company covering hardware development, AI software development, direct sales, and post-sale technical support. When accessing patient health information during maintenance and troubleshooting, the company functions as a HIPAA business associate subject to direct HHS enforcement.
- Geographic exposure
- The majority of operations and employees are U.S.-based, with 99 of 102 employees located in the United States as of February 15, 2026. International commercial markets include Canada, select European and Middle Eastern countries, Australia, New Zealand, and India. Three employees were located in the United Kingdom and Europe as of February 15, 2026.
Source: SEC 10-K, filed 2026-03-18
Industry:
Electromedical & Electrotherapeutic Apparatus
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