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.
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