FDA picks eight medical device firms to help battle opioid crisis

Eight medical device makers, including a startup that uses virtual reality to treat chronic pain, topped an innovation contest aimed at addressing the opioid crisis, the U.S. Food and Drug Administration said on Friday.

Silicon Valley-based startup CognifiSense, which is developing the virtual reality therapy, and iPill Dispenser, which uses a biometrically controlled mobile app that aims to cut overconsumption by dispensing pills based on prescriptions, were among the winners of the FDA’s contest.

The health regulator will work directly with the companies to expedite the development and review of their devices in a manner similar to the agency’s Breakthrough Devices Program, which fast-tracks the review of certain products.

Over 72,000 Americans died from drug overdose last year, including illicit drugs and prescription opioids, with President Donald Trump declaring the opioid addiction crisis a public health emergency.

The FDA received over 250 applications for the innovation challenge, which seeks to prioritize the approval of novel medical devices including digital health technologies such as mobile medical apps.

Under Commissioner Scott Gottlieb, the FDA has raised the bar for approval of opioid-based painkillers by restricting the distribution and use of these drugs. The agency has also rolled out initiatives to encourage developers of alternative therapies.

“We believe the greatest opportunities for medical devices to help prevent opioid use disorder are devices that could help identify people likely to become addicted, devices that manage pain as an alternative to opioids or reduce the need for opioid medications,” the FDA said in a statement here.

https://www.reuters.com/article/us-usa-opioids/fda-picks-eight-medical-device-firms-to-help-battle-opioid-crisis-idUSKCN1NZ2D2