Business
Hyperfine Announces Regulatory Approval of the Swoop® System in India
GUILFORD, Conn., December 17, 2025--Swoop® portable MRI system receives CDSCO approval in India, expanding access to advanced brain imaging in a large, fast-growing healthcare market.
About this update from Hyperfine, Inc.
[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":5227,"height":600,"url":"https://media.zenfs.com/en/business-wire.com/35001669456f63f0ab5bb3ba282f9ec1"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/dL7g97u5rgzSBC0GCkwVSA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTExMDtjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/35001669456f63f0ab5bb3ba282f9ec1","width":960,"height":110},"lightbox":{"url":"https://s.yimg.com/ny/api/res/1.2/QDLrmouodoPreUdK8R0iig--/YXBwaWQ9aGlnaGxhbmRlcjt3PTI0MDA7aD0yNzY7Y2Y9d2VicA--/https://media.zenfs.com/en/business-wire.com/35001669456f63f0ab5bb3ba282f9ec1","width":1200,"height":138}},"lazy":false},{"type":"text","content":"India's Central Drugs Standard Control Organization (CDSCO) has approved the Hyperfine Swoop system, opening a major global market. Commercial launch to begin early 2026.","length":174,"tagName":"p","attribs":{}},{"type":"text","content":"GUILFORD, Conn., December 17, 2025--(BUSINESS WIRE)--Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop® system—today announced the Swoop® system has received regulatory approval in India from the Central Drugs Standard Control Organization (CDSCO), opening access to advanced brain imaging in one of the world's largest and fastest-growing healthcare markets with a significant unmet need.","length":535,"tagName":"p"},{"type":"text","content":"The CDSCO approval authorizes the commercialization of the Swoop® portable MRI system throughout India. Hyperfine will distribute the Swoop® system in partnership with Radiosurgery Global, Ltd. (RSG), a leading medical device distributor with expertise in advanced medical imaging and an established network across India's healthcare system.","length":345,"tagName":"p"},{"type":"text","content":""The partnership between Hyperfine and RSG will enable us to transform a vision into reality. This partnership unites Hyperfine’s transformative portable brain MRI technology with RSG’s deep market access, regulatory fluency, and operational discipline in India," said Kapil Kalra, Managing Director, Radiosurgery Global, Ltd. "This collaboration addresses India’s unmet need ...