Posts Tagged ‘FDA’
The FDA ends precertification (Pre-Cert) pilot program, saying new authority required to regulate software as a medical device (SaMD)
FDA acknowledges shortcomings of Pre-Cert pilot in report (Regulatory Focus): The US Food and Drug Administration (FDA) said it needs additional Congressional authority to move forward with its digital health precertification (Pre-Cert) program. While the idea has been widely lauded by various stakeholders, at least one expert said he feels vindicated for warning the agency early…
Read MoreUpdate: Playing videogames may be more cognitively beneficial than other forms of screentime like social media, watching videos/ TV
Welcome to a new edition of SharpBrains’ e‑newsletter, featuring timely brain & mental health news and a fun brain teaser to put your temporal lobes to good use :-) #1. Study finds that playing videogames may be more cognitively beneficial for children than other forms of screentime (social media, watching videos/ TV) “Here, we estimated the impact…
Read MoreAI-enabled chatbot Wysa receives FDA Breakthrough Device designation for patients with chronic pain, depression and anxiety
AI Behavior Health Chatbot App Fast-Tracked by FDA (Psychology Today): Recently the U.S. Food and Drug Administration (FDA) granted breakthrough device designation to Wysa’s AI-based digital mental health conversational agent that delivers cognitive behavioral therapy (CBT) via a smartphone to adults suffering from depression, anxiety, and chronic musculoskeletal pain
Read More“Digital therapeutics” vs. “Mental health apps”: A growing debate on standards, regulation and efficacy
The efficacy of Mental Health Apps (pharmaforum): In January, PLOS Digital Health published a study which claimed that there’s “sparse” data to support the efficacy of most mental health apps. In their meta-analysis of published studies, the authors found universal deficiencies and concluded that there’s no convincing evidence that app-based interventions deliver meaningful outcomes. Without…
Read MoreFrom “Eminence-based” to Evidence-based cognitive & mental healthcare: Time for quality and accountability
Welcome to a new edition of SharpBrains’ e‑newsletter, featuring timely brain & mental health news, two excellent new books and a few fun brain teasers. #1. From “Eminence-based” to Evidence-based mental healthcare: Time to focus on quality and accountability “The real challenge is not finding a therapist, it’s finding a therapist who knows how to provide…
Read MoreA conversation at the frontier of digital health innovation, FDA regulations, and cognitive health
Digital Therapeutics for MCI and Alzheimer’s disease: A Regulatory Perspective (The Journal of Prevention of Alzheimer’s Disease): –This article is adapted from a comprehensive conversation between Dr. Murali Doraiswamy and Dr. Jeffrey Shuren at the 2021 Clinical Trials on Alzheimer’s Disease (CTAD) conference in Boston. Dr. Shuren is a behavioral neurologist who has held a variety…
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