Posts Tagged ‘digital health’
Brain Health in 2030: Navigating Neuroplasticity & the Digital Health Market
Brain Health in 2030: Navigating Neuroplasticity & the Digital Health Market from SharpBrains Keynote delivered by Álvaro Fernández, CEO of SharpBrains, during corporate retreat. Key message: Our very human brains and minds are the most sophisticated technology at our disposal, so we should invest more time learning about how they work and harnessing neuroplasticity-based methods…
Read MoreThe 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 MoreOn mental fitness beliefs, lifestyles and new tools like apps, digital therapeutics, virtual reality, “brain age gaps” and more
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 believing you can improve mental wellbeing helps actually improve it Beliefs matter. #2. “Digital therapeutics” vs. “Mental health apps”: A growing…
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 MoreFunding for digital health start-ups, especially in mental health, fall substantially in Q1’22
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 first quarter of 2022. The global digital health market saw funding decrease 36% from the fourth quarter of 2021, totaling $10.4 billion, as investors reacted…
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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