Hyperfine has received regulatory approval in India for its Swoop portable MRI system.
The clearance comes through India’s Central Drugs Standard Control Organization and opens access to advanced brain imaging in one of the world's largest and fastest-growing healthcare markets, the company noted.
Hyperfine will distribute the Swoop system in partnership with Radiosurgery Global, a medical device distributor with expertise in advanced medical imaging and an established network across India's healthcare system. Commercial launch will begin in early 2026, Hyperfine said.
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