Hyperfine, Inc. has secured regulatory clearance from India’s Central Drugs Standard Control Organisation (CDSCO) for its “Swoop” portable brain MRI system.

• Accessibility: The ultra-low-field system is designed for use at the point of care, requiring significantly less infrastructure than conventional high-field MRI scanners.
• Distribution: Hyperfine will partner with Radiosurgery Global (RSG) to deploy the AI-powered imaging system across India’s urban and rural healthcare networks.
• Launch: A full commercial rollout is scheduled to commence in early 2026, targeting clinical applications in stroke and traumatic brain injury assessment. 

This summary is based on a press release issued by Hyperfine.