Hyperfine’s bedside MRI system gets FDA nodMarch 25, 2020
Hyperfine Research has received US FDA 510(k) clearance for the bedside magnetic resonance imaging (MRI) system.
The system is 20X lower cost, 35X lower power consumption, and 10X lower weight than today’s fixed conventional MRI systems, said the company.
The point-of-care device is highly portable and wheels directly to the patient’s bedside, plugs into a standard electrical wall outlet, and is controlled via a wireless tablet such as an Apple iPad.
The system was designed to address the limitations of current MRI systems in order to make MRI accessible anytime, anywhere, to any patient.
The FDA clearance includes head imaging for patients 2 years of age and older.
MRI uses a magnetic field, radio waves and a computer to produce detailed pictures of the body’s internal structures that are clearer, more detailed and more likely in some instances to identify and accurately characterize disease than other imaging methods.