Hyperfine-RSG collaboration to address need for accessible brain imaging
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 — has received regulatory approval from India’s Central Drugs Standard Control Organization (CDSCO), which opens 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. Guilford, Connecticut-headquartered 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.
“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 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,” Kalra said on 17 Dec.
India represents one of the most significant global opportunities for improved access to neuroimaging. Despite a population exceeding 1.4 billion, the country has a comparatively limited base of MRI systems, with far fewer high-field scanners per capita than most 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.
“With portability, low infrastructure requirements, and affordability relative to conventional MRI, the Swoop® system is particularly well-suited for India’s diverse healthcare landscape,” said Maria Sainz, President and Chief Executive Officer of Hyperfine, Inc. “From major urban hospitals to remote community health centers, 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.”
She added, “This regulatory approval further advances our global expansion strategy and reinforces the value and opportunity of bringing brain imaging directly to patients worldwide.” Fiinews.com
