Neurometrix has received FDA clearance for a new smartphone-controlled version of , the company announced last week.
Like its predecessor, the device will use nerve stimulation to treat chronic pain by sending signals to the brain that cause it to release natural opioids. It's worn around the calf.
“This 510(k) further advances Quell technology by allowing the device to be conveniently and safely controlled via a smartphone,” Dr. Shai Gozani, president and CEO of NeuroMetrix said in a statement. “It is a clear example of our unwavering commitment to creating the most clinically effective and technologically innovative wearable therapeutic solution for people suffering from chronic pain.”
Quell's previous device, , is smartphone-connected but the app can only be used to monitor the treatment, which is controlled automatically. It allows the user to track sleep as well as to track the neurotherapy the device delivers.
The new device, due out in March, will let the user directly control the nerve stimulation -- they can turn it on and off and increase or decrease therapy levels, and toggle between two different validated therapy modes, one which feels like a constant vibration and one that feels more like a fast pulse.
The new device will track sleep more comprehensively, recording body position and movements while sleeping in addition to sleep time. FInally. it will also boast a longer battery life than the current device, which can last 30 hours on a charge. The company promises a 25 percent increase, which would be about 37 hours.
The device is due out in March 2016 and will be offered as a free upgrade to users who already have last year's version of the device. It will be available in five colors. The company hasn't disclosed the price for the new version, but the existing device costs $249 for a starter kit which includes a one-month supply of electrodes. Additional electrodes cost $29.95 for a one-month supply.