Hyperfine, Inc. announced that its Swoop portable magnetic‑resonance imaging system has received clearance from India’s Central Drugs Standard Control Organization (CDSCO), allowing the device to be sold and used in the country’s healthcare facilities. The approval, granted on December 17, 2025, marks a key milestone in Hyperfine’s strategy to expand beyond the United States and tap into a market with a large population and limited access to conventional MRI scanners.
The CDSCO clearance was obtained through a partnership with Radiosurgery Global, Ltd. (RSG), which will handle regulatory navigation and distribution in India. Hyperfine expects the first commercial units to be available in early 2026, following a brief post‑approval testing period. The approval also aligns with the company’s broader international rollout plan, which includes recent certifications in Canada (November 2021), Australia (February 2022), and the United Kingdom (November 2022).
India’s low‑field MRI market is estimated to be worth several billion dollars, with fewer than 1,000 conventional MRI scanners per 10 million people compared to 10,000 in the United States. Hyperfine’s ultra‑low‑field Swoop system, which requires only a 0.064‑Tesla magnet and can be transported on a dolly, is designed to meet the country’s need for affordable, point‑of‑care brain imaging. Analysts estimate that the Indian market could represent up to 15% of the global low‑field MRI addressable market, offering Hyperfine a significant new revenue stream.
Financially, Hyperfine reported $10.59 million in revenue for the twelve months ending December 17, 2025, while the most recent quarter (Q3 2025) saw revenue of $3.4 million and a net loss of $0.14 per share. The company’s current ratio of 3.63 indicates a solid liquidity position, but cash burn remains a concern as Hyperfine invests in scaling production and expanding its global footprint. The CDSCO approval is expected to accelerate revenue growth in the Indian market, potentially adding several million dollars in annual sales once the product is launched.
The competitive landscape for portable MRI in India includes a handful of low‑field solutions, but Hyperfine’s Swoop system stands out for its proven clinical performance, low infrastructure requirements, and lower cost of ownership. The company’s partnership with RSG also provides a distribution advantage, as RSG has established relationships with major Indian hospitals and diagnostic chains.
President and CEO Maria Sainz emphasized the strategic fit of the Swoop system in India, stating, “With portability, low infrastructure requirements, and affordability relative to conventional MRI, the Swoop system is particularly well‑suited for India’s diverse healthcare landscape.” The approval is seen as a critical step toward achieving Hyperfine’s goal of making brain imaging accessible in underserved regions worldwide.
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