Hyperfine Gets India Approval For Its Swoop System

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.

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.