Hyperfine, Inc., a pioneering health technology company known for its AI-powered portable MRI system, Swoop, has announced that the system has received regulatory approval in India from the Central Drugs Standard Control Organization. This approval allows Hyperfine to bring its portable brain imaging technology to one of the world’s largest healthcare markets, addressing a critical unmet need for accessible neuroimaging.
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The CDSCO authorization permits the commercialization of the Swoop system across India, and Hyperfine will distribute the technology in partnership with Radiosurgery Global, Ltd., a leading medical device distributor with expertise in advanced imaging and an established network within India’s healthcare system. Kapil Kalra, Managing Director at Radiosurgery Global, stated that the partnership combines Hyperfine’s portable MRI innovation with RSG’s market expertise, regulatory knowledge, and operational capacity. He added that this collaboration will expand access to brain imaging, creating a scalable model for the widespread adoption of portable MRI technology throughout the country.
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India presents a significant opportunity to improve neuroimaging access. Despite a population of over 1.4 billion, the country has relatively few MRI systems, particularly high-field scanners, compared with developed nations. Conventional MRI technology requires substantial infrastructure and comes with high costs, limiting availability, especially in remote or low-resource regions. Many patients face long travel times to reach MRI-equipped hospitals and encounter prohibitive expenses, which can delay diagnosis and restrict access to advanced neurological care.
Maria Sainz, President and Chief Executive Officer of Hyperfine, explained that the Swoop system is ideally suited to India’s healthcare environment due to its portability, minimal infrastructure requirements, and lower cost compared with conventional MRI systems. She emphasized that the technology can serve major urban hospitals as well as community health centers in remote areas, providing timely assessment for conditions such as stroke, traumatic brain injury, and neurodegenerative diseases. Sainz added that this approval supports Hyperfine’s global expansion plans and underscores the value of bringing brain imaging directly to patients, improving access to critical neurological care worldwide.
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