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From “Eminence-based” to Evidence-based cognitive & mental healthcare: Time...
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...
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“Digital therapeutics” vs. “Mental health apps”: A growing debate on...
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...
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AI-enabled chatbot Wysa receives FDA Breakthrough Device designation for...
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...
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Update: Playing videogames may be more cognitively beneficial than other...
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...
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The FDA ends precertification (Pre-Cert) pilot program, saying new authority...
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...
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On cognitive-physical training, brain biomarkers, dementia, ketamine, brain...
Welcome to the last 2022 edition of SharpBrains e‑newsletter, featuring a few selected brain health news and fun teasers to challenge your brain and help us all think outside the box. #1. “Everyone...
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CMS: anti-amyloid drug Leqembi (lecanemab) doesn’t meet the “reasonable and...
CMS Sticks to Sharply Limited Coverage of New Alzheimer’s Drug, Leqembi (Managed Healthcare Executive): For now, CMS (Note: Centers for Medicare & Medicaid Services) is sticking to the coverage...
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Growing controversy over role of FDA and Medicare in promoting anti-amyloid...
The War Over Whether Medicare Should Pay For The New Anti-Alzheimer’s Drugs (Forbes): The powerful Alzheimer’s Disease lobby is fighting a multi-billion-dollar battle on two fronts. It is quietly...
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Hopes and Questions raised by Alzheimer’s drug Leqembi (lecanemab)
The FDA has approved Leqembi, the first disease-modifying treatment for early-stage Alzheimer’s and a precursor condition, mild cognitive impairment. Medicare has said it will pay for the therapy....
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Beyond the clinic: Can digital therapeutics (DTx) help boost mental health in...
Hoping to Avoid Pear’s Fate, Behavioral Health-Focused DTx Companies Look to Employer Market (Behavioral Health Business): The digital therapeutics (DTx) industry is at a crossroads after one of the...
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