Hyperfine Receives Breakthrough Designation Approval for Swoop® Portable MRI System

Hyperfine, Inc., has obtained regulatory approval from India’s Central Drugs Standard Control Organization for its Swoop® portable MRI system. 

This clearance paves the way for the commercial launch of the Swoop® system throughout India, expanding access to advanced brain imaging in a rapidly growing healthcare market with significant unmet needs.

Hyperfine will partner with Radiosurgery Global, Ltd., a well-established medical device distributor with expertise in advanced imaging and a nationwide network, to distribute the Swoop® system. 

The partnership aims to broaden access to neuroimaging services across India, reaching both urban hospitals and remote or resource-limited areas where traditional MRI facilities are scarce.

With a population exceeding 1.4 billion but a relatively low number of MRI scanners per capita, India faces challenges in timely diagnosis due to high costs and extensive infrastructure requirements of conventional MRI machines. 

The Swoop® system, with its portability, minimal infrastructure demands, and affordability, is designed to overcome these barriers.

FDA-cleared for brain imaging in patients of all ages, the Swoop® Portable MRI System delivers high-quality diagnostic images suitable for clinical interpretation. 

It enables timely imaging for conditions such as stroke, traumatic brain injury, and neurodegenerative diseases, supporting enhanced patient care across a variety of healthcare settings.