Med Device Monday: A Medical Device for Substance Use Disorders

When we think of treating substance abuse, it's typically drugs, therapies, and various rehabilitations that come to mind. But last week, FDA announced that it has approved marketing of the first medical app (yes, like the kind from the App Store) to help treat Substance Use Disorders (SUD). The device is intended to be used together with outpatient therapy, and it's not intended for use with opioid addiction or for those who are dependent only on alcohol. But still, medical treatment through a mobile app? It's hardly the first time we've said it here, but the future truly is now!

Substance Use Disorder is, in a word, addiction. The Substance Abuse and Mental Health Services Administration shows a group of disorders that fall under this title, including dependence on alcohol, cannabis, tobacco, stimulants, and hallucinogens. Note that they also make clear distinctions about the words they choose to describe these disorders, saying, "The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), no longer uses the terms substance abuse and substance dependence, rather it refers to substance use disorders, which are defined as mild, moderate, or severe to indicate the level of severity, which is determined by the number of diagnostic criteria met by an individual." They go on to say, "Substance use disorders occur when the recurrent use of alcohol and/or drugs causes clinically and functionally significant impairment, such as health problems, disability, and failure to meet major responsibilities at work, school, or home. According to the DSM-5, a diagnosis of substance use disorder is based on evidence of impaired control, social impairment, risky use, and pharmacological criteria.".

Of course, most of us will unfortuantely have at least a passing familiarity with what substance dependence means and looks like. All the more reason that an accessible mobile medical device for treatment is fantastic news. 

reSET Pear Therapies addiction app
Screencaps from

Screencaps from

reSET, from Pear Therapeutics, is the name of this app, which is used on a patient's phone or tablet and monitored by their clinician via a desktop interface. It's designed to encourage and maintain abstinence from the substance the patient is dependent on. It delivers to the patient cognitive behavioral therapy (CBT) and acts as part of a larger overall plan of treatment. In fact, in clinical trials, treatment via reSET saw better outcomes than those patients who used only traditional, in-person therapy. CBT is a system of talk therapy designed to make the patient aware of negative or destructive patterns of thought and change their behavior around them. 

While this medical device is, like any medical device, not a magic bullet, it is really encouraging and exciting to see how technology can serve patients and the medical device community. This is a really promising development and I look forward to following this company and this device in the future. Check out the other devices they have on deck which have not yet been approved, by clicking here.


Further reading:

FDA's de novo approval

Pear Therapeutics press release

FDA press release: FDA permits marketing of mobile medical application for substance use disorder