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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 mental fitness beliefs, lifestyles and new tools like apps, digital...
Welcome to a new edition of SharpBrains’ e‑newsletter, featuring timely brain & mental health news and a fun couple of math brain teasers. #1. Study on the “ABCs of Mental Health” finds that simply...
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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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Funding for digital health start-ups, especially in mental health, fall...
Global digital health funding falls 36% with fewer megarounds, IPOs (Fierce Healthcare): After two years of record-breaking investment in digital health, capital flow into the sector took a dive in the...
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A conversation at the frontier of digital health innovation, FDA regulations,...
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....
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Wearable EEG monitoring start-up Epitel raises $12.5M to market seizure...
Epitel raises $12.5M for wearable seizure detection system (MobiHealth News): Epitel, maker of a wearable electroencephalogram (EEG) system for seizure detection, announced Wednesday it had scored...
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On physical activity, neuroplasticity, depression, screen time,...
Welcome to a new edition of SharpBrains’ e‑newsletter, featuring this time eight scientific reports and industry resources plus a few fun brain teasers. #1. Study finds ultimate hack to protect teen...
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The Federal Trade Commission (FTC) hardens data security rules for health...
FTC says it will fine digital health companies that don’t disclose data breaches (mobihealthnews): With data breaches on the rise, the FTC is looking to make health apps more accountable for telling...
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Study: Self-guided sleep app Sleepio, combined with standard care for...
Study backs benefit of insomnia DTx Sleepio on mental health (pharmaphorum): The study – published in the journal Behaviour Research and Therapy – tested the Sleepio app developed by digital health...
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On centenarians, memory, Mars, tDCS, ADHD, digital health, beautiful brains,...
Hendrikje van Andel Schipper (1890–2005) Welcome to a new edition of SharpBrains’ e‑newsletter, featuring ten timely resources and research findings for lifelong brain and mental fitness. #1. Let’s...
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On Awe, Wonder, Biofeedback, CBSM, Virtual Reality, Privacy, Being Wrong, and...
Welcome to a new edition of SharpBrains’ e‑newsletter, this time featuring eleven timely resources and research findings for lifelong brain health and mental well-being. #1. “Awe is the feeling we...
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Tip for digital health start-ups: To navigate regulatory gray areas, “engage...
FDA’s enforcement discretion for digital health is more ambiguous than ever in 2021 (MobiHealthNews): The digital health ecosystem has swelled to encompass a broad range of products over the years. On...
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Innovation in COVID times: Otsuka and Click Therapeutics announce fully...
Otsuka launches pivotal trial of digital therapeutics for depression (MedCity News): Otsuka Pharmaceutical is launching a virtual study to see if digital therapeutics can reduce depression symptoms....
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Survey finds concerns AND hope to address growing mental health needs due to...
Digital providers come to the fore to support global mental health during pandemic (press release): Research published today shows how digital providers are coming together to support the mental health...
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The landscape of digital mental health apps: huge unmet needs, quality...
Addressing the mental health crisis (Pharma Field): Each day we find out more about the mental health effects of the pandemic. Early on, the Office for National Statistics found that one in five...
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FDA releases first Artificial Intelligence (AI) regulatory plan to promote...
FDA Releases Artificial Intelligence/Machine Learning Action Plan (FDA press release): Today, the U.S. Food and Drug Administration released the agency’s first Artificial Intelligence/Machine Learning...
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Startup Big Health raises $39M to universalize access to cognitive behavioral...
Big Health Hones Digital Mental Health Therapy With $39M Series B (Crunchbase): “Startup Big Health believes individuals can improve their mental health through its technology that focuses on cognitive...
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Update: Moderate lifetime drinking may lead to lower Alzheimer-related beta...
__ Time for a new edition of SharpBrains’ e‑newsletter. #1. First of all, it’s not all bad news this month. Study finds that moderate lifetime drinking may lead to lower Alzheimer-related beta amyloid...
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Digital health start-ups raised a record $3.1 billion in Q1; focus will...
__ Digital health firms raised record sums before Covid-19 hit (MedCity News): “Digital Health startups raised a record-breaking $3.1 billion in the first quarter of 2020, according to a report...
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Meditation apps have gone mainstream in the covid-19 era
__ 1. Best meditation apps: practice mindfulness with Headspace, Calm and more (TechRadar): “The best meditation apps could help you to sleep better, reduce your stress levels and find some much-needed...
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