By Pat Anson, Editor
Smartphones have revolutionized the way we communicate. And they are fast becoming a tool in the treatment of chronic pain.
Wearable medical devices linked to smartphones can not only do simple things like track your pulse and blood pressure, they can help relieve some types of chronic pain without the use of drugs. Several of these new medical devices are being showcased next month at the 2016 International Consumer Electronics Show (CES) January 6-9 in Las Vegas.
One device making its debut at the trade show is the iTens, the first FDA-cleared wireless TENS device that works via an iPhone or Android based app.
Transcutaneous Electrical Nerve Stimulation (TENS) has been used for decades to relieve pain by using electrical stimulation to block or mask pain signals. But the old TENS units typically come with many wires, are anything but portable, and could only be used for limited 30-minute periods.
“The iTENS device was created for people who are in need of a portable, convenient method of pain management that doesn't involve taking prescription medication,” says iTENS CEO Joshua Lefkovitz. “We designed the iTENS to be thin, flexible, discreet, and easy to operate with the push of a button from the iTENS app.”
The iTens uses peel ‘n’ stick gel pads that can be directly applied to painful areas. The pads are powered by a lithium-ion rechargeable battery that can provides relief for up to 24 hours. During that time, the iTENS app measures a user’s pain scale, tracks their results, and charts their progress.
“We’ve got the first clearance from the FDA that has a Bluetooth enabled app,” Lefkowitz told Pain News Network. “There are other wireless TENS devices out there, but none of them are app-enabled.
“It’s really cool, because with an app you can roll in new settings. We’ve got body part settings, condition-specific settings, and you’ve got manual settings so you can pre-program whatever settings you want.”
The iTens device will become commercially available in March for $89.95. No prescription is needed and the device is “FDA-cleared” – meaning the Food and Drug Administration has approved iTens’ safety, but not necessarily its efficacy.
Device makers have a huge advantage over pharmaceutical companies because they are held to a lower regulatory standard and often can get fast track approval from the FDA without any clinical studies – as long as the new device is substantially the same as an old device already on the market.
One disadvantage to that approach is that without full FDA approval, few insurance companies are likely to offer reimbursement for a wearable medical device and physicians are less likely to recommend them.
That conundrum will be addressed at the CES trade show in a panel discussion titled “Roadmap to FDA Approval.” One of the speakers is Shai Gozani, President and CEO of NeuroMetrix Inc., maker of the Quell pain relief device, a neurostimulator worn below the knee
“If wearable technology is going to achieve its tremendous potential it must move beyond wellness to tackling fundamental health problems such as chronic pain, diabetes, and heart disease. This necessarily implies regulation by the FDA,” said Gozani. “I hope this panel will start to demystify the regulatory process and encourage technology companies to embrace the opportunity of consumer medical technology.”
The FDA issued guidance earlier this year on the types of apps that would be subject to regulatory review. The agency said it was not trying to stifle innovation and the regulations would only apply to a “small subset of mobile apps that are medical devices and present a greater risk to patients if they do not work as intended."
The goal is not to regulate “wellness” apps that keep track of things like fitness and nutrition, but apps that make specific claims about diseases and conditions.
According to industry estimates, by 2018 over half of the world’s 3.4 billion smartphone and tablet users will have downloaded mobile health applications