Eight medical device firms have been selected by the Food and Drug Administration (FDA) to help prevent and treat opioid use disorder.
Over 250 applications entered the FDA’s Innovation Challenge. The challenge was intended for diagnostic or therapeutic medical devices, including mobile medical apps that help prevent and treat opioid addiction. The products from the eight companies selected include those intended to predict the risk of opioid addiction, detection, dispense medication and provide pain treatment alternatives to opioids.
Those that were selected were:
- Brainsway (Brainsway Deep Transcrainal Magnetic Stimulation (DTMS) Device)
- Avanos (Pain therapy Device)
- iPill Dispenser (iPill Dispenser)
- Masimo Corporation (Overdose Detection Device)
- ThermoTek (NanoThermTM and VascuTherm TM Systems)
- Milliman (Opioid Prediction Service)
- Algomet Rx (Rapid Drug Screen)
- CognifiSense (Virtual Reality Neuropsychological Therapy)
The regulator will work with the chosen companies and products to accelerate the development and expediate marketing application review, with Breakthrough Device designation granted to devices that meet the statutory criteria without the need of a separate application.
In a statement on the regulator’s website, Jeff Shruen and Jonathan Jarow said: “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. For example, the development of a diagnostic device, whether it be an in vitro diagnostic test, software or a mobile medical app, could be highly impactful in identifying those patients for whom extra caution should be exercised when prescribing opioids for acute or chronic pain.
“We are encouraged, inspired, and motivated by the robust interest that resulted from the Innovation Challenge. The engagement and participation from so many developers is indicative of the dire need we face for new ways to treat this disease, and that medical devices, including digital health technologies, like mobile medical apps, will play a critical role in the FDA’s all hands-on deck approach to confronting the opioid epidemic.”
