Brainspec Receives Breakthrough Device Designation for Virtual Brain Biopsy System

Brainspec has received Breakthrough Device designation from the FDA for its investigational virtual brain biopsy system.

Unlike traditional imaging techniques, Brainspec’s magnetic resonance spectroscopy system measures the concentrations of chemicals in the brain.

One of the system’s selling points is that it can be used on any standard magnetic resonance imaging (MRI) scanner, only adding five to 15 minutes of scan time to a routine MRI exam.

The FDA’s Breakthrough Device designation is for medical devices and device-led combination products that show potential to offer a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.