Last year more than 49,000 people in the United States died from an opioid overdose, and that number looks likely to continue to rise in the future. The issue has escalated to a full-blown public health crisis and battling the opioid epidemic has become one of the Trump Administration’s major priorities.
In response, the FDA launched an innovation challenge to help promote and speed-up the development of devices and therapies intended to prevent and treat opioid use disorder.
The organization has sorted through more than 250 submission to select eight winners of the challenge who will enter into a 90-day collaboration with the FDA to help determine the best regulatory path for the technologies.
The companies will also receive expedited review when they chose to submit a formal application to the organization and if the device meets breakthrough device criteria, it will automatically grant the company the designation.
Here is an overview of the challenge winners:
Algomet Rx, a startup working on a “Rapid Drug Screen” and has technology which provides what it characterizes as a “mechanistic” approach to objective pain measurement and drug effects.
Avanos, a medical device company based in Alpharetta, Georgia, that specializes in pain management technologies.
Israeli company Brainsway, which has developed a Deep Transcranial Magnetic Stimulation Device for depression, that can potentially be turned toward opined addiction therapy.
CognifiSense, a Sunnyvale, California-based startup, which is working on virtual reality therapy for chronic pain management.
iPill Dispenser, a Southern California-based company looking to create a smart medication dispenser protected by biometric authentication.
Irvine-based global medical device company Masimo Corporation, which is hoping to turn its pulse oximetry monitoring capabilities to patients at risk for opioid overdose.
Actuarial and consulting company Milliman which is developing a platform to use data analytics to help flag potentially dangerous opioid prescriptions.
ThermoTek, a company based in Flower Mound, Texas, which has built devices that provide fluid heating, cooling and compression for pain management purposes.
“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 Scott Gottlieb said when the challenge was launched in May.
“We must advance new ways to find tools to help address the human and financial toll of opioid addiction.”
Photo: VladimirSorokin, Getty Images
