Indian Regulators Approve Hyperfine’s Swoop System

Hyperfine Inc. has secured regulatory approval for the Swoop system from India’s Central Drugs Standard Control Organization (CDSCO), thus gaining 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 medical device distributor with expertise in advanced medical imaging and an established network across the country’s healthcare system.

“The partnership between Hyperfine and RSG will enable us to transform a vision into reality. This partnership unites Hyperfine’s 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.”

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,” Hyperfine President/CEO Maria Sainz stated. “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. This regulatory approval further advances our global expansion strategy and reinforces the value and opportunity of bringing brain imaging directly to patients worldwide.”

The Swoop Portable MR Imaging Systems are U.S. Food and Drug Administration (FDA)-cleared for brain imaging in patients of all ages. They are portable, ultra-low-field MRI devices for producing images that display the head’s internal structure where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

Hyperfine Inc. is a health technology company striving to redefine brain imaging with the Swoop system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of professional care. Hyperfine aims to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging. Founded by Dr. Jonathan Rothberg in a technology-based incubator called 4Catalyzer, Hyperfine scientists, engineers, and physicists developed the Swoop system out of a passion for redefining brain imaging methodology and the ways clinicians can apply accessible diagnostic imaging to patient care.