Digital Therapeutics

Investors see promise in digital health — the challenge is adoption

VCs at MedCity INVEST Digital Health said there’s no shortage of interesting digital health companies, even ones that can prove their innovations are effective. The challenge is winning over insurers and physicians, and finding payment models that work. 

Startup testing video-based treatment for ‘lazy eye’ touts Phase 3 results

Luminopia, a startup with a digital therapeutic for amblyopia, or lazy eye, recently published the results of a phase 3 study showing its TV-based treatment can improve vision in kids’ non-dominant eye. Patients don a headset where images are altered to make them use both eyes. 

The tech revolution reshaping European healthcare

The European health tech industry has made a “quantum leap” into using digital health technology due to the pandemic with the help of a growing number of trailblazing entrepreneurs, according to AlbionVC. The London-based venture capital firm provides a useful overview of how healthcare has changed over the last decade, and where digital health is …

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Startup Neuroglee raises $10m for virtual neurology clinics

A digital health company focusing on neurodegenerative disorders – Neuroglee Therapeutics – has raised $10 million in first-round funding to roll out a virtual neurology clinics for people with cognitive problems caused by dementia. The Singapore startup, which is partnering with the Mayo Clinic on the clinics, said the cash injection will also go towards …

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Neuroglee Raises $10M to Develop Virtual Neurology Clinics with Mayo Clinic, Others

What You Should Know: – Neuroglee, a Boston, MA-based provider of personalized evidence-based digital therapeutics (DTx) and virtual care solutions, today announced it has raised $10M in Series A funding led by OpenSpace Ventures with participation by EDBI. – Neuroglee Therapeutics discovers, develops and commercializes personalized evidence-based digital therapeutics (DTx) and virtual care solutions to …

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Study backs benefit of insomnia DTx Sleepio on mental health

A study has shown that people with anxiety or depression who used a digital therapeutic (DTx) for insomnia alongside psychological therapy, had better improvement in their mental health than those receiving therapy on its own. The study – published in the journal Behaviour Research and Therapy – tested the Sleepio app developed by digital health …

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Akili adds to ADHD gaming range with £37m TALi licensing deal

Akili already has the first and only FDA cleared video game-based digital therapeutic (DTx) for children with attention-deficit hyperactivity disorder (ADHD), but is looking to add to its range via a licensing deal with Australia’s TALi Digital.  Flush with cash from a recent $160 million equity and debt financing, Akili has agreed to license US …

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Health Innovators: PureTech Health’s Daphne Zohar

In latest episode of our Health Innovators video interview series, Dr Paul Tunnah speaks to Daphne Zohar, the co-founder and CEO of PureTech Health. They discuss the publicly-listed biotech’s pipeline projects and focus on the BIG (brain-immune-gut) axis as well as PureTech’s interest in digital therapeutics. Daphne explains how she built an impressive team of board …

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Why Healthcare Innovation Needs Human-Centered Principles

Octavio Egea, Executive Strategy Director, frog Millions of people around the world have lost their health as a result of the pandemic. Millions more have lost loved ones. Trillions of dollars have been spent fighting the virus and restoring life post-pandemic, while many families have lost income, savings, or both.  COVID-19 has no doubt been …

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Mahana raises $61m for digital therapeutic for IBS

Mahana Therapeutics has raised second-round financing of $61 million that will be used to launch what it says will be the first prescription digital therapeutics (DTx) for irritable bowel syndrome, one of several digital health products in its pipeline. The Mahana IBS tool – a three-month course that uses cognitive behavioural therapy (CBT) to log …

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Around 250 digital health apps are launching every day, says IQVIA

There was a dramatic increase in the launch of health-related mobile applications last year, taking the total number on offer in app stories to 350,000 – and while average quality is currently “middling” it is on the rise, according to a report from IQVIA. The pandemic contributed to another 90,000 apps being introduced in 2020 …

Around 250 digital health apps are launching every day, says IQVIA Read More »

FDA gives breakthrough status to Biofourmis’ heart failure DTx

A digital therapeutic for patients with heart failure has been awarded breakthrough device status by the FDA – said by its developer Biofourmis  to be the first time the US regulator has given this designation for this type of product. Boston-based Biofourmis claimed the accolade for its BiovitalsHF prescription digital therapeutic (DTx), which is used …

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Biofourmis Earns FDA Breakthrough Device Designation for Digital Therapeutic for Heart Failure

What You Should Know: – Biofourmis, a Boston-based global leader in virtual care and digital therapeutics, announced its BiovitalsHF® solution is the first-ever heart failure digital therapeutic to receive a Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). – The Breakthrough Devices Program was created to provide patients and providers with timely …

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Aptar makes digital health play, agreeing deal to buy Voluntis

Drug delivery specialist Aptar Group has agreed a deal to take a near two-thirds share in Voluntis, a French developer of digital therapeutics (DTx), with a view to taking full control of the company later this year. Illinois-headquartered Apar – which makes inhalers, syringe components, eye drop bottles and other delivery systems for pharmaceuticals, cosmetics …

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Happify launches Ensemble DTx for depression, anxiety in US

Happify Health has launched a prescription digital therapeutic (DTx) – called Ensemble – that can assist the treatment of people with both major depressive disorder and generalised anxiety disorder in the US market. The 10-week smartphone or PC based programme is the first and only prescription DTx for both indications, which according to the digital …

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Dopavision raises €12m for DTx to tackle myopia epidemic

Digital therapeutics (DTx) startup Dopavision has raised funding to develop its lead product, an app designed to slow the progression of myopia – or short-sightedness – in children or adolescents. The €12 million series round, led by Seventure Partners and backed by investors including Novartis, Boehringer Ingelheim and Abbax Health, will be used to fund …

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How digital pathways are changing healthcare

As demonstrated throughout COVID, digital health is no longer experimental. Digital technologies are proving their value by allowing for better care, improved adherence and a more connected ecosystem between doctors, patients and pharma. Ampersand Health has been working in the space since 2015 and has seen it evolve from a niche approach with limited acceptance …

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Manchester joint venture will trial Morningside’s digital health portfolio

The University of Manchester has formed a joint venture with Morningside to carry out clinical trials of various digital health technologies developed by the investment group’s portfolio companies.  Health Innovation Manchester and its Academic Health Science Centre are also participating in the JV, which will focus on digital diagnostics and interventions that could play a …

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Manchester joint venture will trial Morningside’s digital health portfolio

The University of Manchester has formed a joint venture with Morningside to carry out clinical trials of various digital health technologies developed by the investment group’s portfolio companies.  Health Innovation Manchester and its Academic Health Science Centre are also participating in the JV, which will focus on digital diagnostics and interventions that could play a …

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If Big Pharma is from Mars and digital health startups from Venus, PharmStars wants to play Cupid

Digital health startups and pharma industry players sometimes don’t speak the same language, and the culture gap has led to failures in the past. A new accelerator focused on helping digital health companies engage better with pharma hopes to flip the script.

After getting FDA clearance for video game therapeutic, Akili faces next level: insurance coverage

Akili Interactive, a digital health company that got FDA clearance last year for its video game as treatment for ADHD, recently brought in $160 million in funding. It plans to use the funds to ramp up coverage of its flagship treatment and to develop digital treatments for other cognitive conditions. 

Partnerships in pharma: exploring intersections across molecules and software

Earlier this year, Healthware Group and Plexus Ventures formed an alliance to structure deals for the pharmaceutical industry in the development and commercialization of Digital Therapeutic (DTx) products. Given the increased attention and growth seen in the market, both companies are leveraging their expertise to become go-to partners for life sciences companies looking to incorporate DTx into their pipelines. Healthware …

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Mental Health App Forms Bond with Users, Marking Key Evolution in Digital Therapeutics

What You Should Know: – Digital therapeutics company Woebot Health announced its findings to an unprecedented and large-scale industry study that sought to understand whether users of its cognitive-behavioral therapy (CBT)-based conversational agent, Woebot, formed therapeutic alliances (or bonds) with the agent compared to traditional face-to-face therapy and other digital interventions that do not deploy …

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Vicore signs deal with Alex to develop digital therapeutic to support IPF patients

Rare disease specialist Vicore Pharma has signed an agreement with Alex Therapeutics to test a digital therapeutic designed to provide cognitive behavioural therapy support to patients with the lung scarring disease idiopathic pulmonary fibrosis (IPF). The agreement allows for a clinical development programme for Vicore’s digital therapeutic (DTx) VP04. Vicore will own all rights to …

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Digital Therapeutics Startup Kaia Health Raises $75M to Optimize MSK & COPD Care

What You Should Know: – Digital therapeutics company, Kaia Health, has raised $75M Series C round (total: $125M) to expand clinical capabilities and transform the treatment path for Musculoskeletal (MSK) and Chronic obstructive pulmonary disease (COPD) care in the U.S. and Europe. – The Series C round was led by an unnamed leading growth equity fund with support from …

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Voluntis Collaborates with Eisai to Develop Digital Therapeutics for Oncology Patients

Shots: Voluntis enters into a license agreement with Eisai to design & develop DTx for patients and healthcare professionals to support cancer treatment, utilizing the Theraxium technology platform The DTx will be designed with the intent to be commercialized in the US, Japan and EU, which will boost Voluntis’ pipeline and global footprint Additionally, the …

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Jolly Good/Teijin Pharma develop VR digital therapeutics for depression

Technology firm Jolly Good and Teijin Pharma have begun a partnership to develop virtual reality digital therapeutics (VR DTx) for major depressive disorder. The goal of the partnership for approval for the Japanese market from the Pharmaceuticals and Medical Devices Agency (PMDA). Jolly Good has already won a “Home Healthcare Award” in a programme held …

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Ohio is third state to fund Pear’s digital therapeutics to tackle addiction

A third US state has agreed to fund Pear Therapeutics’ digital therapeutics (DTx) to treat people with substance and opioid use disorders.  The company has been pushing for more reimbursement of its three marketed DTx products in the US following a first FDA approval in 2017. Pear said that the Ohio Department of Mental Health …

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HHS reverses previous administration’s push to deregulate more than 80 medical devices

In the final days of the Trump Administration, the Department of Health and Human Services sought to deregulate 83 different types of medical devices, citing a lack of reported adverse events. But the Food and Drug Administration put an end to the sudden reversal, saying the proposed exemptions were “flawed.” 

Better Therapeutics begins ‘real world’ study of digital diabetes therapy

After announcing plans to go public, prescription digital therapeutics (DTx) firm Better Therapeutics has begun a “real world” study to test whether its BT-001 prescription cognitive behavioural therapy tool could change behaviours that are the root cause of type 2 diabetes. The company has begun the open-label, non-randomised, controlled study to test whether the durability …

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Q1 2021 Health IT/Digital Health PC/VE, M&A, IPOs/ SPACs Activity

The first quarter of 2021 has been one of investor optimism as the vaccine rollout continues ahead of expectations and economic activity begins to accelerate in response.  Within the Health IT industry, the already strong investment and M&A trends seen in 2020 have only accelerated.  Over the course of the quarter, we observed $7 billion in private …

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Digital Therapeutics, Megan & Me!

Anyone who follows me knows that I’ve been questioning whether digital therapeutics are real and more importantly whether the people building and trying to sell them are simply trying to replicate the American drug pricing model–patent, protect, prescribe & price gouge. So who better to have this conversation with than the person in charge of …

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Akili’s gaming therapy improves attention in ADHD kids

Akili has published data backing the efficacy of its childhood attention-deficit hyperactivity disorder (ADHD) video game therapy EndeavorRx in the peer-review journal Nature Digital Medicine.  The results come from the STARS-Adjunct trial, an open-label study of EndeavorRx (AKL-T01) that supported approval of the app and video game combination in the US and Europe last year. …

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Gamification for patient care, medical education, and virtual engagement

“Gamification” – adding game-like elements into non-game or real-world settings – has become a popular concept in the pharmaceutical, healthcare, and event industries, especially as virtual engagement becomes more common during COVID-19. However, it is proving more than a mere buzzword. With diverse applications and approaches, it is quickly becoming a promising tool for patient …

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Epillo to pilot blockchain-based DTx with Hydrus7

European digital health firm Epillo is to launch a pilot digital therapeutics (DTx) project in a strategic partnership with US-based blockchain firm Hydrus7 Labs. Epillo’s technology is based around a patient-facing software apps that help patients treat, prevent, or manage the disease. The company said its products help real-time management and monitoring of drug-food constituent …

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Wellstar Invests $10M to Become First Sharecare-Enabled Health System

Wellstar Health System, one of Georgia’s largest and most integrated healthcare systems, and Sharecare, the digital health company that helps people manage all their health in one place, announced a strategic partnership to collaborate on unique, market-leading innovations in personalized care delivery, population health, and consumer engagement. Through this partnership, Wellstar also will become the …

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Otsuka, Click trial digital depression therapy with Google

Otsuka and Click Therapeutics are working with Verily, the healthcare subsidiary of Google owners Alphabet, on a fully remote clinical trial testing a digital therapy as an add-on in adults with severe depression. Otsuka is on a mission to develop digital technology to treat mental illness and broke new ground by marketed Abilify Mycite (aripiprazole) …

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Orexo eyes real-world testing of its modia opioid use disorder app

Orexo will start a new study of its modia app – used to treat people with opioid use disorder – to test how it performs in real-world settings. The Swedish drugmaker has teamed up with consultancy ApexB.io and pharmacy group Magellan Rx Management on the study of the digital therapeutic, which provides tailored cognitive behavioural …

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Italy eyes Digital Therapeutics

The recommendations for the Country’s pathway towards DTx are captured in the White Paper “Digital Therapeutics, an Opportunity for Italy” The official journal of the Smith Kline Foundation, Tendenze Nuove, published the White Paper “Digital Therapeutics, an Opportunity for Italy” on 13 January 2021. The book consists of 208 pages featuring insights and recommendations from …

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White paper reveals pathway for digital therapeutics use in Italy

A white paper has outlined a pathway that could allow Italy to realise the potential of digital therapeutics (DTx). The official journal of the Smith Kline Foundation, Tendenze Nuove, has published the paper entitled “Digital Therapeutics, an Opportunity for Italy” earlier this month. The book features insights and recommendations from 40 leading experts in the …

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DarioHealth Acquires Musculoskeletal Solution Upright for $31M

What You Should Know: – DarioHealth, a Livongo competitor acquires musculoskeletal startup Upright for $31 million to expand their chronic condition management capabilities focused on driving behavior change rather than treating the acute problem. This move will more than double revenue and create one of the largest integrated digital health companies in the space. In …

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Amalgam Rx Acquires Clinical Decision Support Platform Avhana Health – M&A

What You Should Know: – DTx and Patient Support leaders, Amalgam Rx, Inc., announce the acquisition of Avhana Health, a privately-held clinical decision support (CDS) company. Amalgam Rx, Inc., a Wilmington, DE-based Digital Therapeutics and Patient Support company, announces the acquisition of Avhana Health, a privately held clinical decision support (CDS) company, which has deep …

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Humana Taps Vida Health to Power Virtual Diabetes Management for Kentucky’s Medicaid Population

What You Should Know: –  Humana Healthy Horizons™ in Kentucky announced it has selected Vida Health’s virtual diabetes management program to serve Kentucky’s Medicaid population. – Vida’s diabetes management program achieves lasting results for participants. Because chronic conditions like diabetes, obesity, and hypertension often occur simultaneously, Vida’s unique program was built from the ground up to …

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Treating Patients with Software: Digital Therapeutics

The 3rd generation pharmaceuticals- Digital therapeutics- have become a much-discussed aspect of MedTech today, as they compete with established drug-based pharmaceutical and biotech products to become therapeutic interventions for many acute and chronic diseases. Currently, many small- and mid-size companies are working to develop, manufacture and launch their software-based therapeutic interventions, while we are observing …

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Cerner, Banner Health, Xealth Partner to Simplify How Clinicians Prescribe Digital Health

What You Should Know: – Cerner Corporation today announced with Xealth new centralized digital ordering and monitoring for health systems, starting with Banner Health, to foster digital innovation. – Health systems can prescribe digital therapeutics, smartphones, and internet apps directly within the EHR to address areas such as chronic disease management, behavioral health, maternity care, …

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Freespira Secures $10M for FDA-Cleared Digital Therapeutic to Eliminate Panic Attacks, PTSD Symptoms

What You Should Know: – Lightspeed Venture Partners, the VC behind Nest and GrubHub, is leading a $10 million round for Freespira, an FDA-cleared digital therapeutic proven to significantly reduce or eliminate panic attacks and PTSD symptoms by training users to normalize respiratory irregularities. – In 28 days, Freespira can reduce or eliminate panic attacks …

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Pear Therapeutics Raises $80M to Advance Prescription Digital Therapeutics

What You Should Know: – Pear Therapeutics today announced that it has successfully closed an $80 million Series D financing led by SoftBank Vision Fund 2. –  Pear is the leader in prescription digital therapeutics and the first company to receive FDA authorization for a prescription digital therapeutic (PDT) to treat disease. – Pear currently …

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UCB Taps Medisafe to Develop Branded Digital Drug Companions for Antiepileptic Medications

What You Should Know: – UCB has selected Medisafe to develop branded digital drug companions for antiepileptic medications, marking the company’s official entry into the digital therapeutics space. – The initial collaboration will primarily be focused on their antiepileptic medications, but they are exploring its use for additional brands.  Medisafe, a leading digital therapeutics company …

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Digital therapeutics: Why human psychology is key to adoption

The healthcare system is running at its limits in many countries worldwide. One reason is the growing demand for healthcare, largely driven by the rise of chronic diseases. COVID-19 has further underscored just how stretched the system is today. Is there any solution to the twin challenge of managing costs while extending capacity? We believe …

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Frontiers Health 2020 day two

It’s day two of digital health innovation conference Frontiers Health, which will be mainly held online because of the COVID-19 pandemic. This year Frontiers will be a global Hybrid conference. In line with the “new normal” situation, the format of the 2020 edition will be hybrid combining online global streaming together with offline events and activities held at hubs in multiple locations such as Italy, Germany, Finland, Spain, …

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Frontiers Health 2020 day one

Digital health innovation conference Frontiers Health kicks off its 2020 edition this week, although the majority of the conference will be held online because of the COVID-19 pandemic. This year, Frontiers will be a global Hybrid conference. In line with the “new normal” situation, the format of the 2020 edition will be hybrid, combining online global streaming together …

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Digital therapies for opioid use disorder need more data, says ICER

There isn’t enough evidence to suggest that digital therapies for people with opioid use disorder (OUD) can improve on standard interventions, according to the Institute for Clinical and Economic Review. The US cost-effectiveness watchdog has concluded in an evidence report that none of three digital therapies under scrutiny – apps from Pear Therapeutics, Chess Health …

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Aptar Pharma Acquires the Assets of Respiratory Startup Cohero Health

What You Should Know: – Apstar Pharma acquires the assets of respiratory health company Cohero Health to expands its digital portfolio with a focus on respiratory disease management. – Cohero Health develops digital tools and technologies to improve respiratory care, reduce avoidable costs, and optimize medication utilization. AptarGroup, Inc., a global leader in consumer dispensing, …

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Deep Dive: Digital Health Innovation 2020

Most of the digital health experts we spoke to for this issue of Deep Dive made one thing clear – no one can really say what the future holds for digital tech in the pharma and healthcare industries. But this isn’t necessarily a bad thing – our interviewees also stressed that if companies can remain …

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FDA Grants AppliedVR Breakthrough Designation for Virtual Reality Chronic Pain Treatment

What You Should Know: – FDA awards AppliedVR Breakthrough Device designation for treating treatment-resistant fibromyalgia and chronic intractable lower back pain – AppliedVR’s EaseVRx program helps patients learn self-management skills grounded in evidence-based cognitive-behavioral therapy (CBT) principles and other behavioral methods. AppliedVR, a pioneer advancing the next generation of digital medicine, today announced its EaseVRx …

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Akili presents new real-world data from therapeutic ADHD video game

Akili has new data from its childhood hyperactivity therapeutic video game EndeavorRx, as the company builds a case for the technology with longer-term trial data. The company announced several new data readouts, including outcomes data from the STARS-Adjunct trial, a multi-site open-label study testing EndeavorRx on impairments in daily life in children with attention-deficit/hyperactivity disorder …

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Consumers Cite Trump as Leading Driver of COVID-19 Vaccine Skepticism

What You Should Know: – 65% of patients say they will wait to receive the forthcoming COVID-19 vaccine even if it becomes available before the end, according to a new Medisafe survey. – Consumers cited greater trust in Dr. Anthony Fauci and established protocols as a leading factor in determining whether to take the vaccine, …

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Digital Therapeutics: Key Concepts and Regulations to Tackle COVID-19 Pandemic

Digital therapeutics are clinically validated applications / software / online programs that have demonstrated the capability to facilitate positive outcomes when used in the prevention / treatment / management of diseases / clinical conditions. These therapeutics are designed to engage patients in personalized treatment or disease prevention programs, through mediating behavioral or psychological modifications, providing …

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Limbix digital therapeutic for adolescent mental health finds niche amid Covid-19 pandemic

The Silicon Valley startup plans to start its registration-directed study of Limbix Spark in the earlier part of next year and – if successful – would anticipate FDA clearance in early 2022.

Top 20 Innovative Digital Therapeutics Companies of 2019

The recent decades have shown an accelerated development and evolution in the technology world, leading to unexpected growth in digital health companies. The Digital Therapeutics companies aid patients to schedule appointments, view medical records and seek medical advice without visiting clinics or hospitals. With the aid of health information technology, wearable devices, telehealth, telemedicine, and …

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Digital Therapeutics Company DarioHealth Raises $28M to Expand Market Share

What You Should Know: DarioHealth raises $28M in institutional financing intended to finance growth of their digital therapeutics B2B market share with employers, health insurance plans, and healthcare providers. The company sold 2,969,266 shares of common stock and, to certain investors in lieu thereof, pre-funded warrants to purchase 824,689 shares of common stock at an …

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Digital therapy firms link up with Swiss accelerator Kickstart

Several digital therapy and digital health firms have been selected to join a group of startups by the innovation platform, Kickstart, linking them with a range of investors in an initiative beginning in autumn. The digital therapy companies include SidekickHealth and Kaia Health, focusing on gamified digital therapies and physiotherapy respectively. Founded by two medical …

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Biocon Collaborates with Voluntis on Digital Therapeutics for Insulins

Shots: The two companies collaborated to develop and distribute innovative digital therapeutics supporting people with diabetes on biologics therapy. The collaboration allows Biocon to offer Insulia to T2D patients across several markets globally Biocon aspires to reimagine the patient ecosystem by developing a technology-dependent operating model enabling personalization of care, thus going beyond the product …

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DarioHealth, Williams Medical Partner to Expand Digital Therapeutics Platform Across the UK and Ireland

What You Should Know: – Dario Health enters strategic partnership with Williams Medical marking its expansion into the UK remote patient monitoring market across the UK and Ireland. – Williams Medical is the leading provider of medical goods and services to primary care in the UK, and this agreement supports both companies’ commitment to drive …

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10 Healthcare Innovations That Can Reduce Total Disease Burden 6-10% by 2040

What You Should Know: –  40 percent of the global disease burden could be addressed with known interventions, but that leaves 60 percent unaddressed. – As part of the recent McKinsey report Prioritizing health: A prescription for prosperity, the McKinsey Global Institute identified ten promising innovations that can reduce total disease burden 6-10% by 2040. …

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Scripps Research, Repurpose.AI Partner to Develop COVID-19 Therapeutics

What You Should Know: – Repurpose.AI, has partnered with Scripps Research to discover drug candidates that may be repurposed to treat COVID-19.  – The partnership will leverage Repurpose.AI’s ActivPred AI Drug Discovery Platform, an unbiased drug, target, and disease agnostic digital chemistry engine, to discover drug candidates to treat COVID-19.  Scripps Research is teaming up …

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