Feb 14,2023

Digital mental health tech for children and young people recommended by NICE in first rapid healthtech guidance

Four digital technologies that can help children and young people with mild to moderate symptoms of anxiety or low mood, including SilverCloud Health, have been recommended for use in the NHS once they achieve regulatory approval. These four technologies, using games, videos and quizzes, represent a promising step forward for new treatment options for children and young people, with early evidence showing they could help improve symptoms of anxiety or low mood.

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Feb 14,2023

Delivering holistic care for physical health conditions through digital talking therapies

Could digital talking therapies tools help to provide more well-rounded care to people with physical health conditions? Health Innovation Network project manager Gemma Dakin discusses the potential benefits of these digital tools and work being done to increase their usage. Talking therapies use techniques such as guided self-help or cognitive behavioural therapy (CBT) to help people self-manage their symptoms and find improve their wellbeing. They are most suited to treating mental health problems of relatively low severity; there is a growing nationally-recognised evidence base suggesting they can improve the quality of life for people with physical health conditions ranging from diabetes to lower back pain. Featuring SilverCloud Health, Mahane Therapeutics, Limbic and Minddistrict as examples.

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Feb 15,2023

Aimmed’s Somzz becomes Korea’s first approved DTx device for insomnia

The Ministry of Food and Drug Safety (MFDS) said that Aimmed’s Somzz for treating insomnia was the first digital therapeutics (DTx) device to receive domestic marketing approval at a press briefing on Wednesday. The MFDS reviewed the results of six-month clinical trials conducted by Aimmed at three domestic clinical trial institutions for Somzz and confirmed that the DTx device statistically improved the insomnia severity assessment scale before and after its use. Somzz is a software medical device that implements cognitive behavioral treatment (CBT) to treat insomnia patients in the form of a mobile application. It improves insomnia by increasing sleep efficiency through sleep habit training, real-time feedback, and behavioral intervention provided by the mobile app for 6 to 9 weeks.

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#mobile app

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Jan 05,2023

Mental Health App Woebot Passes ORCHA’s Rigorous New Digital Health Assessment Framework

Woebot, a mental health app from Woebot Health, has passed the rigorous new Digital Health Assessment Framework (DHAF) that aims to enhance health application standards in the United States. The open framework includes components to assess privacy and security, clinical assurance and safety, and usability, and was crafted to support U.S.-specific guidelines, regulations and best practices for digital health technologies.

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#software

#chatbot

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Jan 23,2023

Woebot Health Enrolls First Patient in Pivotal Clinical Trial of WB001 for Postpartum Depression

Woebot Health today announced the enrollment of the first patient in a pivotal clinical trial to evaluate the safety and efficacy of WB001, an investigational digital therapeutic for postpartum depression (PPD) that was granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) in 2021. The multi-center, double-blind, randomized controlled study is actively recruiting women ages 22 to 45 who have given birth in the last three months and are experiencing mild to moderate PPD.

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#software

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Nov 30,2022

SILVERCLOUD WINS HSE TENDER TO PROVIDE DIGITAL MENTAL HEALTH TREATMENT

Irish founded tech company SilverCloud Health has signed a national partnership agreement with the Health Service Executive (HSE) to provide online mental health services to patients across the country. The HSE rolled out a pilot version of the company’s digital CBT programme in 2021, which received more than 10,000 referrals from GPs and primary care psychotherapists. It said in a statement on Wednesday that active use of its digital platform has doubled since the 12-month review of the pilot programme in April.

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Dec 08,2022

Better Therapeutics Completes Exploratory Trial for Fatty Liver Disease and Announces Positive Topline Results

Better Therapeutics today announced positive results of the first-ever study evaluating the feasibility of using a prescription digital therapeutic to reduce liver fat and improve liver disease biomarkers in Nonalcoholic Fatty Liver Disease (NAFLD) and Nonalcoholic Steatohepatitis (NASH). The study included a cohort of 22 patients with NAFLD and NASH and used Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) scans, a validated proxy for liver biopsies, to monitor changes in liver fat. The study relied on Better Therapeutics’ CBT platform, which has been developed with the intention of helping patients with cardiometabolic diseases – including NASH and NAFLD – access a tailored treatment that leverages CBT techniques to address underlying causes of these diseases and help them make sustainable behavioral changes.

CLINICAL STUDY

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Dec 20,2022

HelloBetter Sleep: First online therapy programme for organic and nonorganic insomnia available on prescription in Germany

HelloBetter Sleep has secured approval as HelloBetter’s sixth DiGA (prescription digital therapeutic) by the German Federal Institute for Drugs and Medical Devices (BfArM) and is now included in the DiGA directory. HelloBetter Sleep is the only prescription digital therapeutic that is approved not just for the treatment of nonorganic insomnia (ICD-10 F51.0), but also organic insomnia (ICD-10 G47.0) in Germany. All statutory as well as many private health insurers will cover the costs of HelloBetter Sleep in full, making it available free of charge to 73 million people in Germany. Over the last 14 months, HelloBetter has managed to secure six regulatory DiGA approvals – more than any other company.

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Jan 10,2020

Mahana Therapeutics Enters Into Licensing Agreement With King's College London for Innovative Digital Therapeutic to Treat Gastrointestinal Condition

Mahana Therapeutics, a digital therapeutics company, today announced that the Company has entered into a licensing and collaboration agreement with King's College London. Mahana has acquired a worldwide exclusive license to an innovative digital therapeutic for the treatment of irritable bowel syndrome (IBS).

COLLABORATION PARTNERSHIP

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Mar 06,2020

Orexo submits application for vorvida® to the FDA to enable commercialization in the US

Orexo AB (publ), today announces it has submitted an application to the US Food and Drug Administration (FDA) for vorvida® to enable commercialization in the US. vorvida®, is a digital therapy with clinically proven efficacy for the treatment of bothersome or harmful alcohol consumption including diagnosed alcohol use disorder (AUD). Today’s news follows the November 2019 announcement of Orexo’s acquisition of the US commercialization rights of the therapy from GAIA. vorvida® (Orexo project no. OXD02) is a digital therapeutic designed to offer patients quality psychotherapy intervention based on cognitive behavioral therapy and motivational interviewing.

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