Posts Tagged ‘digital health’
Tip for digital health start-ups: To navigate regulatory gray areas, “engage early and engage often” with the FDA
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 one end of the spectrum is software-as-medical-devices (SaMD) and prescription digital therapeutics, product categories for which a comprehensive regulatory strategy and engagement with the FDA…
Read MoreInnovation in COVID times: Otsuka and Click Therapeutics announce fully virtual clinical trial, leveraging Verily’s Project Baseline
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. It’s the next step in a partnership between the Tokyo-based drugmaker and Click Therapeutics, a digital health startup that is developing programs for smoking cessation, depression and insomnia.
Read MoreSurvey finds concerns AND hope to address growing mental health needs due to the covid pandemic
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 needs of millions of users unable to access traditional services during the COVID-19 pandemic.
Read MoreThe landscape of digital mental health apps: huge unmet needs, quality concerns, app stores asked to ensure transparency
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 Britons reported symptoms of depression, compared with one in 10 before. And, according to a recent study led by the University of Nottingham…
Read MoreFDA releases first Artificial Intelligence (AI) regulatory plan to promote responsible digital health innovation
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 (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. This action plan describes a multi-pronged approach to advance the Agency’s oversight of AI/ML-based medical software … The AI/ML-Based Software as a…
Read MoreStartup Big Health raises $39M to universalize access to cognitive behavioral therapy (CBT) for anxiety and poor sleep
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 behavioral therapy versus medication or the help of human therapists. On Thursday it raised $39 million in a Series B financing to advance that objective.
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