FDA announces eight winners of opioid epidemic innovation challenge

The eight devices will receive increased guidance and interaction for their clearance efforts, and some will receive Breakthrough Device designation.
By Jonah Comstock
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The FDA has announced the winners of the opioid addiction innovation challenge the agency launched last May. Out of more than 250 applications from medical device developers, the FDA selected eight winners. 

"While these products will not automatically receive marketing authorization from the FDA, the device developers will receive increased interaction with CDRH experts, guidance for clinical trial development plans, and expedited review," Drs. Jeffrey Shuren and Jonathan Jarow, director and chief medical officer respectively of the FDA's Center for Devices and Radiological Health, wrote in a blog post announcing the winners.

"Breakthrough Device designation will be granted to those devices selected in the Challenge that meet the statutory criteria for designation upon request by the sponsor," Shuren and Jarow continued. "In most cases, applicants will eventually submit one or more formal applications to the FDA, such as an Investigational Device Exemption, De Novo request, 510(k) premarket notification, or Premarket Approval. The review of these applications will be expedited to minimize review times, however, patient safety is our number one priority and all product applicants will still be held to the FDA’s gold standard and required to meet the applicable standard of safety and effectiveness."

The eight devices that won the challenge are:

  • Brainsway, an Israeli company developing Deep Transcranial Magnetic Stimulation devices, currently for depression and OCD.
  • Georgia-based medical device company Avanos, which has developed a pain therapy device.
  • iPill Dispenser, a company working on smart pill bottles to prevent overdosing or sharing of opioids using security measures like fingerprint biometrics.
  • Pulse oximetry giant Masimo, which submitted an overdose detection device.
  • Wound compression therapy company ThermoTek, which offers non-opioid pain treatment alternatives for certain patients.
  • Actuarial consultancy company Milliman, which submitted a system for predicting opioid overprescription.
  • Algomet Rx, a stealthy startup working on a product called "Rapid Drug Screen."
  • CognifiSense, a company working on virtual reality treatments for chronic pain.

Why it matters

Opioids were responsible for more than 70,000 deaths in 2017, up from 40,000 in 2016. The combination of overprescription and insufficient treatment resources have led to a rising epidemic that disproportionately affects midwestern and rural America. The FDA believes that novel technologies can help to address the crisis. 

"Medical devices, including digital health devices like mobile medical apps, have the potential to play a unique and important role in tackling the opioid crisis,” FDA Commissioner Dr. Scott Gottlieb said when he announced the challenge in May. “We must advance new ways to find tools to help address the human and financial toll of opioid addiction.”

What's the trend?

In many ways the opioid crisis has become the signature medical issue of the Trump administration, with initiatives to fight the epidemic arising in an HHS code-a-thon, a CDC blockchain pilot with IBM, rare bipartisan legislation to improve telemedicine and e-prescribing resources, and more.

The FDA itself, meanwhile, has recently approved at least two novel devices aimed at addressing opioid abuse: a wearable auricular neurostimulation device from DeAnsys designed to treat symptoms of opioid withdrawal, and reSET-O, a digital therapeutic for opioid use disorder from Pear Therapeutics that received an Expedited Access Pathway (EAP) designation from the FDA last year. Pear Therapeutics is also a part of the agency's Pre-Cert pilot program.