Hyperfine Inc., a health technology company based in Guilford, CT, has secured regulatory approval from India’s Central Drugs Standard Control Organization (CDSCO) for its Swoop system (depicted below).
This authorization allows for the commercialization of the portable, ultra-low-field, AI-powered, magnetic resonance brain imaging system capable of providing imaging at multiple points of care in a healthcare facility. By removing the need for specialized cooled rooms and heavy power requirements, the technology aims to provide geographic and economic access to brain imaging in one of the world’s largest healthcare markets.
To manage distribution and market entry, Hyperfine has entered into a partnership with London, UK.-based Radiosurgery Global, Ltd. (RSG), a medical device distributor.
Although India has a population of over 1.4 billion, the number of high-field MRI scanners per capita remains dramatically lower than in most developed nations. Historically, the adoption of neuroimaging has been limited by the high costs and complex infrastructure required for conventional, fixed MRI suites. Additionally, for people located in remote regions, reaching an MRI facility can often result in long travel time.
According to the company, its Swoop system is designed to operate with lower infrastructure requirements and at a lower cost point than traditional MRI units. Its portability allows it to be used in various settings, ranging from large urban hospitals to remote community health centers. By bringing imaging capabilities directly to the patient, the system is intended to assist healthcare providers in the assessment of conditions such as stroke, traumatic brain injury, and neurodegenerative diseases.
Stroke is a huge and growing problem across India, borne out by proprietary Amritt studies in the past. The country also suffers from a high rate of traffic accidents; with many new highways, speeds are rising and the incidence of traumatic brain injury has skyrocketed.
Maria Sainz, President and Chief Executive Officer of Hyperfine Inc., said, “This regulatory approval further advances our global expansion strategy.”
Last updated: December 26th, 2025
