US regulators snip red tape for medical devices to curb opioid epidemic crisis

Stimwave Technologies Inc. owner Laura Perryman expected her company to have to wait years before U.S. approval for her device providing pain relief for chronic migraines.

Now it seems that it will only take months thanks to a new initiative by the FDA to use medical devices, mobile medical apps, and diagnostics to address the country’s opioid epidemic.

Even President Trump Knows There is a Problem

Last year, 70,000 Americans died from drug overdoses, in turn, President Donald Trump declared a public health emergency over the abuse of opioid painkillers such as oxycodone, hydrocodone, and many others.

Over 200 submission have been received by the FDA for companies seeking faster approval process for their painkilling devices. Companies from Stimwave Technologies all the way to industry leaders such as Abbott Laboratories and other industry giants.

The FDA wants to help

FDA Commissioner Scott Gottlieb stated “we’re pleased by the robust interest in this innovation challenge and the acknowledgment from developers about the unique and important role medical devices, including digital health technologies like mobiles medical apps, have the potential to play in tackling the opioid crisis,”

Perryman’s Halo devices took 4 years to get U.S. approval under other names for easing leg and back pain. The Halo is a device so thin it looks like angel hair pasta, it can be injected into a nerve. Opioids are currently used to treat 50 percent of patients who come to the emergency room with a migraine, Perryman hopes her device will gain a spot in the FDA program as an alternative to opioids.

To read more about the devices, addiction and this initiative see the Reuters article here:

https://www.reuters.com/article/us-usa-opioids-focus/u-s-regulators-snip-red-tape-for-medical-devices-to-curb-opioid-crisis-idUSKCN1NE0GQ