Bioelectronics Corp (BIEL)

[markjohn62]

FDA innovation challenge https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhinnovation/ucm609082.htm

List of Applicants Selected for the Challenge

The FDA received an overwhelming response to the FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder. Over 250 applications were received from medical device developers large and small. After careful review using an established set of criteria, eight challenge participants have been selected. The medical devices from the selected participants include those intended to predict the risk of opioid used disorder (OUD), detect opioid overdose, dispense medication and provide pain treatment alternatives to opioids.


Company


Product Name


Category

Algomet Rx, Inc.


Rapid Drug Screen


Monitoring

Avanos


Withheld Per Company Request


Other

Brainsway, Ltd


Brainsway Deep Transcranial Magnetic Stimulation (DTMS) Device


Opioid Use Disorder Therapy

CognifiSense, Inc.


Virtual Reality Neuropsychological Therapy (VRNT)


Pain Therapy

iPill Dispenser


iPill Dispenser


Medication Dispensing

Masimo Corporation


Withheld Per Company Request


Overdose Therapy

Milliman


Opioid Prediction Service


Diagnostic

ThermoTek, Inc.


NanoThermTM and VascuThermTM Systems


Pain Therapy