FDA clears first focused-ultrasound device for chronic low back pain
FUSMobile's Neurolyser XR uses X-ray-guided ultrasound to heat and disable pain-sensing nerves in spinal facet joints, without incisions.
The FDA has granted De Novo authorization to FUSMobile’s Neurolyser XR, the first focused-ultrasound device for chronic low back pain. Guided by X-ray imaging, it focuses high-intensity ultrasound on the small sensory nerves in the spine’s facet joints and heats them to block pain signals, with no needles or incisions. The device is also approved in the EU and Canada.
Focused ultrasound already treats tremor in the brain. Its expansion to the spine shows the technology spreading across pain medicine.
Learn more: Focused ultrasound