NeuroMetrix’s App May Require FDA Approval
When it became apparent that medical and fitness uses would be one of the biggest drivers for wearables, a lot of people groaned. The Food and Drug Administration would have to get involved.
As it turned out, the FDA was doing some groaning of its own about the prospect, and earlier this year, it released draft guidance for low-risk medical devices that essentially said it was taking a hands-off approach. These are general wellness devices, it said of the new class of wearables that measured sleep and exercise and calorie consumption. It wouldn’t be coming after consumers’ beloved Fitbits.
Key, though, is the definition of low-risk devices: They aren’t invasive; they don’t involve lasers or radiation exposure; and they don’t raise new usability or bio-compatability issues.
Also key was the FDA’s declaration that there is a subset of apps it would be regulating. The FDA calls them mobile medical apps and defines them as apps that are de facto medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended.
And so the lines were drawn. The FDA would leave the general-health apps and wearables alone, but regulate what it deemed to be medical device apps. Now, though, as both apps and wearables increase in functionality, it seems as though those lines are set to blur. It didn’t take long at all.
A New Approach to Pain Management
Enter NeuroMetrix. It is a publicly traded company that recently launched Quell, an over-the-counter device that uses electrical nerve stimulation to manage pain.
Quell, briefly, works with the body’s sensory nervous system to send neural pulses to the brain, triggering pain relief. The device is calibrated to provide the exact amount of relief needed and to work 24/7 — that is why NeuroMetric designed it to wrap around the calf. Quell also comes with a smartphone app for the users to track their therapy.
While it may sound like something more befitting a late-night television ad, one user — an unpaid user — tells me it works. She describes it as “a pleasant electrical stimulation or vibration that blocks the pain messages from where they are being generated. So when the pain signals get to the spinal cord, it doesn’t recognize them as that much pain.” You’ll hear her story in a moment.
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