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Digital Therapeutics | Digital Health | Evidence-Based Therapeutics Interventions

Build Smart, Not Fast: What the FDA Really Cares About in Digital Therapeutics

by Justin Kozak Executive VP at Founder Shield 07/29/2025 Leave a Comment

Build Smart, Not Fast: What the FDA Really Cares About in Digital Therapeutics

Digital therapeutics (DTx) are revolutionizing healthcare — from smart inhalers to virtual therapy avatars. As more patients turn to DTx apps, companies rush to deliver innovative features. But in the race to innovate, many developers neglect vital elements of success, leading to major setbacks, especially when seeking FDA approval. It’s time to find a practical path forward to mitigate risk and scale smarter.  The Digital Therapeutics Trifecta:
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Click Therapeutics Obtains FDA Authorization for First Prescription Digital Therapeutic for Migraine Prevention

by Fred Pennic 04/15/2025 Leave a Comment

Click Therapeutics Obtains FDA Authorization for First Prescription Digital Therapeutic for Migraine Prevention

What You Should Know:  - Click Therapeutics, Inc. (“Click”), a leader in the rapidly evolving field of prescription medical treatments, encompassing both prescription digital therapeutics (PDTs) and software-enhanced drug™ therapies has received FDA marketing authorization for CT-132, the first prescription digital therapeutic specifically indicated for the preventive treatment of episodic migraine in adults aged 18 and older. - The FDA granted a De Novo Classification Request for
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ATA Action Acquires Digital Therapeutics Alliance, Forms New Digital Health Coalition

by Fred Pennic 03/31/2025 Leave a Comment

ATA Action Acquires Digital Therapeutics Alliance, Forms New Digital Health Coalition

What You Should Know:  - ATA Action, the advocacy arm of the American Telemedicine Association (ATA), has announced its acquisition of the Digital Therapeutics Alliance (DTA), the leading international organization focused on expanding access to digital therapeutics (DTx).  - The acquisition creates a powerful, unified platform for policy and advocacy, dedicated to advancing innovative technologies that are reshaping patient care. The Boards of Directors of the ATA, ATA Action,
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Dassault Systèmes Invests in Click Therapeutics to Advance Digital Therapeutics

by Fred Pennic 03/19/2025 Leave a Comment

Dassault Systèmes Invests in Click Therapeutics to Advance Digital Therapeutics

What You Should Know:  - Dassault Systèmes has announced a strategic investment in Click Therapeutics, a pioneering company in prescription digital therapeutics (PDTs) and software-enhanced (SE) drug therapies. This investment signifies Dassault Systèmes' commitment to transforming the patient experience within the life sciences and healthcare sectors through comprehensive, end-to-end technology solutions. The investment builds upon the existing collaboration between Dassault
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Mika Health, AstraZeneca, and Daiichi Sankyo Partner on UNITE Program

by Jasmine Pennic 06/19/2024 Leave a Comment

Mika Health, AstraZeneca, and Daiichi Sankyo Partner on UNITE Program

What You Should Know:  - Mika Health, a leading developer of digital therapeutics for cancer patients, announced a collaborative initiative called "UNITE" alongside pharmaceutical giants AstraZeneca and Daiichi Sankyo.  - The strategic initiative signifies a commitment to cross-industry collaboration to enhance the lives of cancer patients and is expected to pave the way for AI-powered solutions in other disease areas. Mika Health: A Proven Digital Therapeutic Platform Mika
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Virtual Therapeutics Acquires Akili: Stock to Go Private After Merger

by Fred Pennic 05/30/2024 Leave a Comment

Virtual Therapeutics Acquires Akili: Gaming Meets Digital Therapeutics for Mental Health

What You Should Know:  - Virtual Therapeutics, a leader in using engaging games for mental health treatment, announced today it will acquire Akili, Inc. (Nasdaq: AKLI), a prominent digital therapeutics company. This merger creates a diversified powerhouse in the digital health industry. - Once the acquisition is complete, Akili's common stock will be delisted from all public stock exchanges. The combined entity's focus on mental health and broader digital therapeutics solutions
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UNP Scores $32M for AI-Powered Macrocycle Therapeutics

by Fred Pennic 12/19/2023 Leave a Comment

UNP Scores $32M for AI-Powered Macrocycle Therapeutics

What You Should Know: - Unnatural Products, Inc. (UNP), a biotech company harnessing the power of AI and chemistry to design the next generation of targeted therapeutics, has secured $32M in Series A funding. - Led by Merck Global Health Innovation Fund (MGHIF) and TechBio-focused ARTIS Ventures,  the funding will help propel UNP's innovative platform and expand its reach beyond oncology, tackling a wider range of medical challenges. Macrocycles: Nature's Key to Untapped Drug
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U.S. Digital Therapeutics Market to Reach $21.46B by 2030

by Jasmine Pennic 06/16/2023 Leave a Comment

U.S. Digital Therapeutics Market to Reach $21.46B by 2030

What You Should Know:  The U.S. digital therapeutics market size is estimated to reach $21.46B by 2030, expanding at a CAGR of 33.8% from 2023 to 2030, according to a new reports by Coherent Market Insights, Inc. Digital therapeutics solutions help improve medication adherence with personalized incentives to encourage long-term behavior change in patients and people with chronic conditions. The report reveals government initiatives to digitalize healthcare is one of the key trends
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Improving Physical Therapist and Patient Experiences with Technology Innovation

by Patrick Tarnowski, Chief Commercial Officer, OneStep 06/07/2023 Leave a Comment

Improving Physical Therapist and Patient Experiences with Technology Innovation

Today’s physical therapists are exhausted and drowning in debt from school loans. Looking at the physical therapy (PT) profession as a whole, there is an average turnover rate of 13.6%, a significant portion of the current healthcare industry’s staggering rate of 100.5% turnover, over the last 5 years, according to Daily Pay’s Healthcare Turnover Rates [2022 Edition]. What’s even more concerning is that 1 in 3 rehab professionals describe themselves as burnt-out. What’s contributing to such
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Expectations For The Connected Care Business In The Years Ahead

by Russ Johannesson, CEO at Glooko 05/02/2023 Leave a Comment

Expectations For The Connected Care Business In The Years Ahead

Though we seldom see their use in our modern world and, even then, only in fiction, there was a time when it was common for people to actually use things like crystal balls and divining rods to try to uncover unknown yet valuable information. As unbelievable as it may seem, soothsayers peered into crystal balls aiming to help seekers look into the future for guidance, while prospectors would rely earnestly on divining rods as they attempted to locate underground riches of water or oil. While
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