Happify Health is launching its first prescription digital therapeutic (PDTx), called Ensemble, which will focus on treating Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD).
Unlike Happify’s other products, Ensemble has to be prescribed by a clinician. Patients are able to use the smartphone or computer in order to tap into the therapeutic. The PDTx is focused on helping...
Better Therapeutics, a nutritional cognitive behavioral therapy digital therapeutics company, announced plans today to go public by merging with special purpose acquisition company Mountain Crest Acquisition Corp II.
The deal is expected to close this summer, subject to stockholder approval, and will raise $113 million for the combined company. It includes a $50 million private investment in...
Those keeping an eye on the digital therapeutics industry over the last several years likely remember the name Dthera Sciences.
The startup and its CEO Ed Cox became one of the developing space's many standard bearers around 2018. During that timeframe it landed a Breakthrough Device designation from the FDA for its Alzheimer's symptoms treatment, with Cox chairing a handful of industry...
Prescription digital therapeutics company Pear Therapeutics announced this morning that it has added $20 million more to an $80 million Series D funding round announced back in December.
The company did not name any participants of this second closing, but highlighted "a leading national Integrated Delivery Network" as the source of the $20 million and the digital therapeutics company's newest...
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 are mandatory. On the other are wellness apps and other low-risk digital tools that likely spend more time...
Otsuka Pharmaceutical and Click Therapeutics have announced the launch of a new, fully remote clinical trial being conducted on Verily's Project Baseline platform.
Called the Mirai study, it will be measuring a digital therapeutics intervention's effectiveness in reducing symptoms of depression among adults who have a major depressive disorder (MDD) diagnosis and are on antidepressant monotherapy...
Digital therapeutics have been plodding on a steady path toward acceptance within healthcare, but the modality reached new heights during a year of unprecedented adoption for digital health technologies. More and more software-based treatments are picking up regulatory approvals – including three De Novo clearances in 2020 alone – while the ongoing COVID-19 pandemic has exposed more consumers,...
Novartis has published results from a clinical trial of Pear Therapeutics' new digital therapeutic for schizophrenia, and the results don't paint a rosy picture.
The single-blinded 112-person trial found no difference between the Pear app and a placebo app in any outcome measure, including the primary outcome measure of reducing schizophrenia symptoms. However, the trial did further establish the...
Bold Health, a London-based company developing digital therapeutics for gastrointestinal conditions, is backing a new University of Pennsylvania-led study that will directly compare the company's cognitive behavior therapy (CBT) app for irritable bowel syndrome (IBS) to Headspace's consumer mindfulness and meditation app.
According to a clinicaltrials.gov listing spotted by Exits & Outcomes,...
Prescription digital therapeutics startup Pear Therapeutics announced an $80 million Series D round this morning headed by SoftBank Vision Fund 2.
The raise included funds from new backers Forth Management, Pilot House, Sarissa Capital, Shanda Group and QUAD Investment Management, as well as from returning investors Temasek, 5AM Ventures, Arboretum Ventures, JAZZ Venture Partners, Novartis,...
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