The FDA’s Center for Devices and Radiological Health (CDRH) in Washington, DC launched an Innovation Challenge for medical device developers to address the opioid addiction crisis with new technologies.
The CDRH received over 250 submissions and has recently selected eight medical developers which are working on innovative, safe and effective medical device technologies for opioid addiction which fully met its criteria.
According to the World Health Organization (WHO), there has been a global increase in the production, transportation and consumption of opioids. The WHO describes opioid addiction as “a complex health condition that often requires long-term treatment and care.”
The medical device developers
The eight medical device developers and technologies selected are as follows:
• BrainsWay Ltd.’s Deep Transcranial Magnetic Stimulation Device, which is FDA-approved for the treatment of obsessive-compulsive disorder (OCD);
• iPill Dispenser, a digital biometric mobile app which ensures that pills are dispensed as prescribed;
• Avanos pain therapy device;
• An overdose detection device from Masimo Corp.;
• ThermoTek Inc.’s NanoTherm and VascuTherm thermal compression therapy products;
• Milliman’s Opioid Prediction Service;
• Algomet Rx Inc.’s rapid drug screening product; and
• CognifiSense Inc., a start-up company who are developing virtual reality–based therapy.
CDRH Director Jeff Shuren, MD, and Jonathan Jarow, MD, wrote on the FDA website: “In each proposal, applicants described the novelty of the medical device or concept; the development plan for the medical device; the team who would be responsible for developing the device; the anticipated benefit of the device when used by patients; and the impact on public health as compared to other available alternatives. Medical devices at any stage of development were eligible for the challenge. Feasibility and the potential impact of the FDA’s participation in development to expedite marketing of the device were also factors considered when reviewing the submissions.”
Although these products will not automatically receive marketing authorisation from the FDA, the device developers will benefit from guidance for clinical trial development plans and expedited review.