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Best DTx - FDA Approved Products

Best DTx - FDA Approved Products

Digital therapeutics that have received clearance or approval from the Food and Drug Administration.
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DTx - FDA Approved: Products


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The Welldoc Platform includes: 

  • An artificial intelligence (AI) driven digital coaching app, providing personalized, actionable guidance and longitudinal feedback based on the six dimensions of health (1) Symptoms, (2) Food, (3) Activity, (4) Pscho-Social, (5) Medications and (6) Labs to help support the patient throughout their chronic care journey. 
  • Integrated mental wellbeing support that educates individuals through their behavioral patterns to design a personalized strategy and action plan. 
  • Comprehensive Digital Coaching and Education based on clinical standards adapted and digitized from Centers for Disease Control and Prevention (CDC) and American Heart Association (AHA) programs 
  • Reporting and workflow integration enabling care teams to easily access data insights to inform clinical interventions and decisions. This includes our Management Portal that provides care management with enhanced population-level health data and analysis. 
  • Availability in a neutral US Spanish, with cultural changes made for the target audience

Our approach addresses combinations of cardiometabolic conditions and comorbidities, all intended to bring more timely, personalized, meaningful digital engagement and health support.

The ways in which the Welldoc platform supports:

Diabetes

  • For use by individuals with Type 1 or Type 2 Diabetes
  • Delivers Real-time coaching and medication management
  • Includes educational content from Association of Diabetes Care and Education Specialists (ADCES)
  • Supports insulin management for individuals and their care teams
  • Encourages healthy eating within the individual’s target carb range through coaching, meal planning, and other features
  • Integrates hypertension and weight management

Weight Management

  • Uses Artificial Intelligence (AI) to provide immediate, tailored and relevant coaching for your members in the moment when they’re making day to day decisions about their health.  
  • Supports members to set clinically appropriate and achievable goals around weight and other health areas (like nutrition and activity)
  • Supports a curated journey with holistic coaching tools ranging from food and nutrition, activity, sleep and where applicable medication
  • GLP-1's -It is Welldoc's philosophy and approach to support a member's holistic weight loss journey whether or not they are using GLP-1's for obesity. Welldoc is not a prescriber. However, we support GLP-1 usage by educating, coaching and requesting that members track their medication adherence, side effects, protein intake, muscle retention and other metrics related to overall weight management.

Hypertension

  • Provides in-app content based on American Heart Association (AHA) guidelines
  • Assists with medication adherence by setting reminders
  • Connects with Bluetooth blood pressure cuffs
  • Delivers coaching messages with each blood pressure and weight entry
  • Incorporates and tracks food that supports the Dietary Approaches to Support Hypertension (DASH) Diet

Diabetes & Hypertension

  • Individuals receive coaching and feedback primarily to manage their diabetes, with key messages that also support hypertension

Heart failure

  • Supports healthy eating habits related to fluid intake, lower sodium, and managing weight gain and loss
  • Provides in-app content based on AHA guidelines
  • Tracks and analyzes symptoms related to heart failure
  • Tracks changes in weight to identify potential fluid retention
  • Provides 24/7 automated coaching for BP, symptoms, and weight

Diabetes & Heart Failure

  • Individuals receive coaching and feedback, prioritized for heart failure, with key messages that also support diabetes and hypertension

Pre-Diabetes

  • Based on Center for Disease Control and Prevention (CDC) standards to reduce risk of type 2 diabetes
  • Calorie counter and food tracking
  • Personalized automated insights based on weight, activity, and blood pressure entries
  • Integrated coaching provided per CDC program guidelines
  • Education and support for weight loss
  • Configurable for your needs extending beyond CDC standards

Healthy Lifestyle

  • Calorie counter and food tracking
  • Personalized automated insights based on weight and activity
  • Education and Support for weight loss
  • Encourage meals within target calorie range through coaching, meal planning, and other features
  • Personalized nutrition guidance coaching with real-time feedback to support progress and better health
  • Large, multi-cultural food database providing a diverse selection of option

Welldoc is not intended to replace the care provided by a licensed healthcare professional. Welldoc does not support severe mental health diagnosis. Please see welldoc.com for full indications of use.

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Integration & Interoperability
Patient Education & Coaching
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Biofourmis brings the right care to every person, no matter where they are. The company’s AI-driven solutions provide people everywhere with connected access to hospital-level services, virtual provider networks for remote care, and life-changing clinical trials—all without leaving their homes. Trusted by leading health systems, life science companies and patients alike, Biofourmis’ connected platform improves patient outcomes, accelerates drug development, and closes critical gaps in care—ultimately making science smarter, healthcare simpler, and patients healthier.

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product capabilities
Multimodal delivery options
Personalized care plans
Connected FDA-approved devices
Integration and interoperability
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key clients
Leading Health System
Health system
Leading Health System
Health system
Leading Health System
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Leading Health System
Health system
+50 verified clients
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The Propeller Digital Therapeutic Platform

Propeller’s FDA-cleared digital therapeutic platform consists of Bluetooth-enabled sensors, a digital patient experience through mobile app or web portal, a clinician insights portal for remote monitoring, plus tailored patient support through virtual coaching. These components seamlessly integrate with one another to improve health outcomes for patients, and in turn, drive measurable clinical and business outcomes for healthcare organizations. Here’s how it works:

  1. PropellerConnect™ Sensors & Data Connectivity: Propeller sensors capture unique signals that passively record events, such as medication usage or respiration, and transmit data to Propeller via Bluetooth or hub connection. Sensors are compatible with more than 80% of inhaled medications on the U.S. market, including medications for MDI, Respimat®, Diskus®, Ellipta®, and Symbicort® inhalers.*
  2. MyPropeller™ Patient App & Portal: Sensor data is sent to the Propeller mobile app or online portal, empowering patients to learn about their breathing and triggers while delivering personalized, motivating journeys that build healthy habits.
  3. PropellerInsight™ Clinical Decision Support & Analytics: Via an EHR integration or our Clinician Portal, care teams can remotely monitor patients’ medication use and view on-demand reports to gain a clearer understanding of disease control status, symptoms, and triggers. These insights help inform clinical decisions and treatment plans, and enable proactive identification of patients who may be at a greater risk for an exacerbation and require timely clinical intervention.
  4. PropellerCare™ Support and Coaching: Propeller’s patient success team ensures users receive personalized support and coaching to help them confidently navigate the platform, stay focused on their goals, and take control of their breathing.

Propeller Health Solutions

Propeller configures its digital therapeutic platform into a variety of solutions that help healthcare and life sciences organizations meet their goals while navigating the shift to value-based care.

  • For Independent Physician Groups: Remote therapeutic monitoring programs to enhance care for eligible chronic patients
  • For Hospitals and Health Systems: Digital health programs for select clinics, target populations, or systemwide; integration into a service line/specialty for population health management
  • For Payers and Pharmacy Benefits Managers: Integration of digital health programs into existing care management or population health initiatives
  • For Life Sciences Organizations: Integration or co-packaging of digital companion (i.e., sensor, app, support) with connected drug delivery devices such as inhalers to support clinical trials, medication adherence, and biologics

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*Respimat is a registered trademark of Boehringer Ingelheim Pharmaceuticals, Inc. Diskus and Ellipta are registered trademarks of the GlaxoSmithKline group of companies. Symbicort is a registered trademark of the AstraZeneca group of companies.

View full profile
product capabilities
Data Collection
Analytics
Accessibility & Equity
Patient Education & Coaching
Multimodal delivery options
Personalized care plans
Connected FDA-approved devices
See more
key clients
Leading Health System
Health system
Leading Health System
Health system
Leading Health System
Health system
Leading Health System
Health system
+50 verified clients
To see which organizations are using this product, sign in or create a free account.

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EndeavorRx is an ADHD treatment for kids aged 8-12. It’s delivered through an immersive video game experience on mobile devices. Created by world-class neuroscientists and award-winning game designers, it targets areas of the brain that play a key role in attention function. As an FDA-authorized medical device, EndeavorRx must be prescribed by a healthcare professional. It should be considered for use as part of a therapeutic program.

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key clients
Leading Health System
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Leading Health System
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Leading Health System
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Leading Health System
Health system
+50 verified clients
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NightWare develops an application on an Apple Watch that aims to help people suffering from nightmares. The company offers wearable technology that learns sleep patterns and customizes a treatment for each individual. NightWare was founded in 2015 and is based in Hopkins, Minnesota.

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key clients
Leading Health System
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Leading Health System
Health system
Leading Health System
Health system
Leading Health System
Health system
+50 verified clients
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reSET-O, the first PDT to receive Breakthrough Designation and authorized by FDA in December 2018, is an 84-day Prescription Digital Therapeutic (PDT) for Opioid Use Disorder (OUD) intended to increase retention of patients in outpatient treatment by providing cognitive behavioral therapy (CBT), as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician.

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key clients
Leading Health System
Health system
Leading Health System
Health system
Leading Health System
Health system
Leading Health System
Health system
+50 verified clients
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Somryst® is the first and only prescription digital therapeutic indicated to treat chronic insomnia. Somryst is intended to improve insomnia symptoms by providing neurobehavioral intervention (cognitive behavioral therapy for insomnia – CBT-I) to adults 22 years of age and older with chronic insomnia.

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key clients
Leading Health System
Health system
Leading Health System
Health system
Leading Health System
Health system
Leading Health System
Health system
+50 verified clients
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