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Tag: FDA
07/12/2022

Digital Therapeutic for Substance Use Disorder Drives Down Care Utilization, Cost

Article Excerpt: Digital therapeutics firm Pear Therapeutics has released new data showing its prescription substance use disorder (SUD) therapy reduces hospitalizations and lowers healthcare costs for patients. The data will be published in the journal Advances in Therapy, but the findings are currently available online as a pre-print. The treatment is called reSET. The app is built around cognitive behavioral therapy (CBT) utilizing the community reinforcement approach (CRA), the company said. It includes a 12-week course of therapy, in which patients are incentivized for completing lessons and abstaining from drug use. The app also includes fluency training designed to reinforce the lesson content. Previous studies have shown the therapy can be effective at improving rates of abstinence and treatment retention when coupled with usual treatments. In the new report, investigators wanted to know how such improvements might translate into changes in healthcare resource utilization and costs.

Full Article: https://tinyurl.com/ybezxs3e

Article Source: Managed Healthcare Executive

05/23/2022

Wysa Receives FDA Breakthrough Designation for CBT Tool

Article Excerpt: Wysa, an artificial intelligence (AI) based digital companion for behavioural health, has been granted Breakthrough Device Designation by the Food and Drug Administration (FDA) for its AI-based digital mental health conversational agent for patients 18 years and older with a diagnosis of chronic musculoskeletal pain (defined as pain lasting longer than three months) and depression and anxiety. The device delivers cognitive behavioural therapy (CBT) via a smartphone-based conversational agent to reduce the symptoms of depression and anxiety, reduce pain interference, and improve physical function.

Full Article: https://tinyurl.com/2kz3nvsk

Article Source: Med-Tech Innovation News

05/02/2022

Does Online Opioid Treatment Work?

Article Excerpt: While Covid-19’s death toll grabbed the spotlight these past two years, another epidemic continued marching grimly onward in America: deaths from opioid overdose. A record 68,630 individuals died from opioid overdoses in 2020, partly as a result of the isolation and social distancing forced by the pandemic; early data suggest that death rates in many states were even worse in the first half of 2021. But the coronavirus pandemic may also have had a paradoxical benefit for those addicted to opioids: Because Covid-19 made in-person health care unsafe, US telehealth regulations were relaxed so that more services — including addiction treatment — could be provided online. As a result, people with opioid use disorder are accessing medication and support across the country in greater numbers than ever before. While it’s too soon to know for sure whether this helps more people kick their addiction, early signs are promising.

Full Article: https://tinyurl.com/ae7ytv7v

Article Source: Knowable Magazine

04/26/2022

Can Virtual Reality Help Ease Chronic Pain?

Article Excerpt: Chronic pain is generally defined as pain that has lasted three months or longer. It is one of the leading causes of long-term disability in the world. By some measures, 50 million Americans live with chronic pain, in part because the power of medicine to relieve pain remains woefully inadequate. As Daniel Clauw, who runs the Chronic Pain and Fatigue Research Center at the University of Michigan, put it in a 2019 lecture, there isn’t “any drug in any chronic-pain state that works in better than one out of three people.” He went on to say that nonpharmacological therapy should instead be “front and center in managing chronic pain — rather than opioids, or for that matter, any of our drugs.”Virtual reality is emerging as an unlikely tool for solving this intractable problem. The V.R. segment in health care alone, which according to some estimates is already valued at billions of dollars, is expected to grow by multiples of that in the next few years, with researchers seeing potential for it to help with everything from anxiety and depression to rehabilitation after strokes to surgeons strategizing where they will cut and stitch. In November, the Food and Drug Administration gave authorization for the first V.R. product to be marketed for the treatment of chronic pain.

Full Article: https://tinyurl.com/3wkx6p8z

Article Source: The New York Times Magazine

02/28/2022

Digital Therapeutics Should Be Regulated With Gold-Standard Evidence

Article Excerpt: There is enormous growth in the digital health sector, illustrated by huge capital investment, and a massive proliferation of mental and behavioral health apps and associated marketing claims. We are particularly concerned about one component of this sector, namely “software as a medical device”, which the Food and Drug Administration (FDA) defines as “software intended to be used for one or more medical purposes,….without being part of a hardware medical device,” and where the purpose is “treatment or alleviation of disease.” This new approach to treatment, increasingly referred to as digital therapeutics (DTx), has the potential to transform mental health care. The global DTx market was valued at more than $3.5 billion in 2020 and is projected to reach $23.5 billion by 2030. According to industry reporting, the largest number of DTx programs today are related to mental health, and most FDA submissions for DTx use cognitive behavioral therapy to promote behavior change in conditions ranging from insomnia to substance use disorder. The opportunity for innovation is clear. However, there are challenges that must be addressed.

Full Article: https://tinyurl.com/2myajfns

Article Source: Health Affairs

02/02/2022

Pfizer, Alex Therapeutics Commercialize a Digital Therapy to Help with Smoking

Article Excerpt: Pfizer is partnering with Swedish digital therapeutics (DTx) company Alex Therapeutics to commercialize a smartphone-based nicotine cessation program (dubbed Eila). Currently, Pfizer is helping get the DTx clinically validated. The companies plan to commercialize the DTx in Germany first, and eventually to other international markets.

Full Article: https://tinyurl.com/yp44z7nh

Article Source: Insider Intelligence eMarketer

01/10/2022

FDA Grants Breakthrough Therapy Designation to Device to Treat AML-Induced Depression

Article Excerpt: The FDA has granted a breakthrough device designation to BNT200, a digital therapeutic designed to treat anxiety and depressive symptoms in adults with acute myeloid leukemia (AML) currently hospitalized for a regimen of high-intensity induction chemotherapy, according to a press release by Blue Note Therapeutics. BNT200 is a software that is designed to treat the unique psychological stressors that create anxiety and depressive symptoms in adult patients with AML undergoing high-intensity induction chemotherapy. It is an on-demand digital therapeutic, with content synchronized with high-intensity chemotherapy treatment.

Full Article: https://tinyurl.com/2p8pvxty

Article Source: Targeted Oncology

11/22/2021

Pear Therapeutics Receives FDA Breakthrough Device Designation for Prescription Digital Therapeutic Candidate to Treat Alcohol Use Disorder

Article Excerpt: Pear Therapeutics, the leader in developing and commercializing software-based medicines called prescription digital therapeutics (PDTs), today announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its reSET-A™ PDT product candidate designed for the treatment of alcohol use disorder (AUD). reSET-A potentially expands Pear’s addiction franchise, which includes FDA-authorized products to treat substance use disorder (SUD) and opioid use disorder (OUD). This is the second such Breakthrough Device Designation received by Pear, following the designation awarded for reSET-O®, the first ever for a PDT, which was for the treatment of OUD.

Full Article: https://tinyurl.com/2unk29uj

Article Source: BioSpace

11/01/2021

FDA Grants Breakthrough Designation to Magnus’ Neurostimulation Technology

Article Excerpt: The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Magnus Medical’s neurostimulation technology for the treatment of major depressive disorder (MDD). Developed based on the SAINT technology, the new, non-invasive Magnus System acts rapidly and is designed to treat MDD in people who have not sufficiently recovered after receiving antidepressant medication or other therapies… According to an investigational randomised controlled trial (RCT) published on the American Journal of Psychiatry website, the individually targeted neurostimulation technology relieved severe depression in 79% of people who received active treatment.

Full Article: https://tinyurl.com/ythtbdjr

Article Source: Medical Device Network