Hyperfine, Inc.: directors' dealings · United States · SEC (Form 4)

About Hyperfine, Inc.

Hyperfine, Inc. (Nasdaq: HYPR) is a U.S.-based medical technology company focused on portable, ultra-low-field brain imaging. Headquartered in Guilford, Connecticut, United States, the company develops and commercializes the Swoop® platform, which it describes as the first FDA-cleared portable MRI system for brain imaging. For French, Belgian, and Swiss investors, Hyperfine sits at the intersection of digital health, diagnostic imaging, and point-of-care care delivery, with a proposition built around accessibility, portability, and the ability to bring brain MRI closer to the patient. ([sec.gov](https://www.sec.gov/Archives/edgar/data/0001833769/000119312526114044/hypr-20251231.htm?utm_source=openai)) Hyperfine was founded in 2014 by Dr. Jonathan Rothberg inside the technology incubator 4Catalyzer. The company’s origin story is strongly tied to innovation in applied imaging engineering and to a mission of making MRI more accessible and affordable. Hyperfine later became a public company and is listed on the Nasdaq, where its Class A common stock trades under the symbol HYPR. Its regulatory history has been central to the investment case: the company received initial FDA 510(k) clearance for the Swoop system in 2020 and has since continued to add additional clearances and software upgrades. ([sec.gov](https://www.sec.gov/Archives/edgar/data/0001833769/000119312526114044/hypr-20251231.htm?utm_source=openai)) The business is centered on the Swoop system and related software and service offerings, most notably the Optive AI™ software suite. These products are intended to improve image quality, clinical workflow, and diagnostic utility while supporting use in sites of care where conventional MRI is difficult to deploy. Hyperfine’s commercial strategy targets hospitals, emergency departments, neurology offices, and international markets, positioning the company as a differentiated alternative to traditional MRI vendors rather than a direct replacement. Its competitive edge lies in portability, lower infrastructure requirements, and the ability to image at the point of care. ([investors.hyperfine.io](https://investors.hyperfine.io/news-releases/news-release-details/hyperfine-announces-fda-clearance-optive-aitm-software/?utm_source=openai)) Geographically, Hyperfine remains primarily U.S.-centric, with core operations in Connecticut and a broader commercial and development footprint that also includes California. At the same time, management has been clearly signaling international expansion. In 2025 and 2026 the company secured CE and UKCA marks for the next-generation Swoop system and Optive AI software, opening access to the European Economic Area and the United Kingdom. The company also disclosed a small number of employees in the UK and Europe, indicating the beginnings of a broader overseas presence. ([sec.gov](https://www.sec.gov/Archives/edgar/data/0001833769/000119312526114044/hypr-20251231.htm?utm_source=openai)) Recent milestones are important. In 2025 Hyperfine announced FDA clearance for a next-generation Swoop system powered by Optive AI, followed by the first commercial sales of that system to U.S. hospitals. In early 2026, management highlighted momentum in hospital, neurology office, and international channels, while also presenting clinical data related to stroke detection and neurology use cases. The investment narrative therefore remains a classic medtech commercialization story: proprietary technology, expanding clinical evidence, and regulatory progress on one side, versus execution risk, reimbursement complexity, and the need to convert innovation into sustained revenue growth on the other. ([investors.hyperfine.io](https://investors.hyperfine.io/news-releases/news-release-details/hyperfine-announces-fda-clearance-new-next-generation-swoopr?utm_source=openai))