Hyperfine has announced that its artificial intelligence (AI)-powered 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”, as stated in a press release from the company.
The CDSCO approval authorises the commercialisation of the Swoop portable magnetic resonance imaging (MRI) system throughout India.
Hyperfine says it will distribute the Swoop system in partnership with Radiosurgery Global (RSG), a leading medical device distributor with expertise in advanced medical imaging and an established network across India’s healthcare system.
“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 at RSG. “This collaboration addresses India’s unmet need for accessible brain imaging while establishing a scalable pathway for sustained adoption of portable MRI throughout the healthcare system—transforming how and where neurological imaging is delivered across the country.”
Hyperfine notes in its recent release that India represents one of the most significant global opportunities for improved access to neuroimaging. Despite a population exceeding 1.4 billion people, the country has a comparatively limited base of MRI systems, with far fewer high-field scanners per capita than the majority of developed nations. The high cost and complex infrastructure requirements of conventional MRI systems have historically prevented widespread adoption across India’s diverse healthcare landscape. Many patients—particularly those in remote or lower-resource settings—face long travel times to reach hospitals with MRI suites and prohibitive imaging costs, contributing to delayed diagnosis and limiting access to advanced neurological care, Hyperfine also details.
“With portability, low infrastructure requirements, and affordability relative to conventional MRI, the Swoop system is particularly well-suited for India’s diverse healthcare landscape,” commented Maria Sainz, president and chief executive officer (CEO) of Hyperfine. “From major urban hospitals to remote community health centres, the Swoop system expands both geographic and economic access to brain imaging—helping providers deliver timely assessment for conditions such as stroke, traumatic brain injury, and neurodegenerative conditions.
“This regulatory approval further advances our global expansion strategy, and reinforces the value and opportunity of bringing brain imaging directly to patients worldwide.”
