Healthcare technology firm Hyperfine Research has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its portable bedside MRI scanner.
The system is designed to roll directly to a patient's bedside and plug into a standard electrical wall outlet. The system can be controlled through a wireless tablet, such as an Apple iPad. The FDA clearance enables Hyperfine to market the system for MRI head scans for patients 2 years of age and older.
The FDA's clearance allows the company to follow up on its plans to begin shipments of its point-of-care device in the third quarter.
