MEDICAL DEVICES MUSTERS : TECH

LAURA Perryman expected her medical company, Stimwave Technologies Inc, would have to wait several years for its painkilling device to win US approval as a treatment for chronic migraines.

She now thinks it could be done in months, thanks to a new initiative by US Food and Drug Administration to use medical-device based treatments, diagnostic tests and mobile medical apps to address the world's opioid crisis.

When President Donald Trump declared a public health emergency over the abuse of heavy-duty  painkillers like oxycodone and hydrocodone, he ordered all government agencies to take action in response to the death of 70,000 Americans last year from opioid overdoses.

The FDA told Reuters it has received over 200 submissions from companies seeking a speedy approval process for their devices. 

These range from Stimwave's Halo to painkilling products made by the Abbott Laboratories and other industry heavyweights as an alternative opioids.

''We're pleased by the robust interest in this innovation challenge and the acknowledgement from the developers about the unique and important role medical devices including  digital health technologies  like-

Mobile medical apps, have the potential to play in tackling the opioid crisis,'' FDA Commissioner Scott Gottlieb said.

Parryman's Halo devices, which like angel hair pasta and are so small they can be injected into a nerve, took four years to get  US approval under other names for easing leg back pain.

She hopes a spot on the FDA program will see  Halo approved within a year as an alternative to opioid, which are currently used to treat an estimated 50 percent of patients  who come to emergency room with migraines.

''This is a kind of perfect for something like ours since the device is shown to be safe already,''  said Perryman, who founded privately held Stimwave in South Florida seven years ago.

The Operational Research continues. [Agencies].