EndeavourRx

Video source: Akili Interactive, at https://www.akiliinteractive.com/ An FDA approved prescription treatment video game for children with Attention Deficit Hyperactivity Disorder (ADHD) which is one of the most common psychiatric disorders in... Read the full review at https://reviews.childrenstech.com/ctr/review.php?id=20267 Want more reviews of children's technology products? Subscribe at childrenstech.com/subscribe

The US Food and Drug Administration (FDA) cleared the first digital prescription attention treatment device (EndeavorRx™: prescription-only game-based device) to improve attention in pediatric patients ages 8 to 12 years old with attention deficit hyperactivity disorder (ADHD) delivered through a video game.This innovative approach to treating ADHD represents a significant advancement in the field of pediatric mental health. This video introduces Endeavor, a US FDA-cleared digital therapeutic device designed to improve attention in children with Attention Deficit Hyperactivity Disorder (ADHD). The device was evaluated through the de novo regulatory process, based on five clinical studies involving over 600 children. Key Features: Usage: Endeavor is a mobile device treatment used for 25-30 minutes daily, five days a week, over a one-month period. Children must complete five game missions each day, with a summary screen displaying progress, goals, and rewards after each mission. Reward System: Rewards can be redeemed for unlocking costumes in the game, promoting engagement. Scientific Basis: The treatment is based on scientific principles that target and strengthen brain regions that regulate attention. Safety Considerations: Endeavor incorporates advanced cybersecurity measures. It may not be suitable for children with photosensitive epilepsy, color blindness, or physical limitations affecting mobile device use. Parents are advised to consult healthcare providers for guidance. EndeavorRx™ is designed to engage children in a way that traditional therapies might not, utilizing interactive gameplay to promote cognitive skills related to attention and focus. The game tailors its challenges to the individual player, adapting in real time to optimize engagement and efficacy. Clinical studies have demonstrated that participants using EndeavorRx™ showed improvements in attention measures compared to those receiving standard care. The FDA's decision underscores the potential for digital therapeutics to serve as a viable complement to medication and behavioral therapies typically prescribed for ADHD. By incorporating gamification into treatment, EndeavorRx™ not only seeks to enhance clinical outcomes but also aims to increase the likelihood of adherence among younger patients, who may find traditional therapeutic methods less appealing. As the landscape of mental health treatment continues to evolve, the integration of technology within therapeutic frameworks opens new avenues for patient engagement and empowers families in managing ADHD symptoms. Such advancements herald a future where personalized, interactive care becomes the norm, offering hope for improved clinical outcomes and a better quality of life for children living with ADHD. #Endeavor #ADHD #DigitalTherapeutics #FDAApproved #ChildHealth #Attention #MobileDevice #GameBasedLearning #MentalHealth #TherapeuticGaming FDA-cleared and approved digital prescription products include: 1. Digital Therapeutics: Solutions for chronic conditions like diabetes and hypertension, offering personalized treatment plans and real-time monitoring. 2. Mobile Health Apps: FDA-approved apps provide medication reminders, symptom tracking, and virtual consultations, enhancing patient engagement and adherence. 3. Prescription Management Software: Enables electronic prescribing, improving medication management efficiency and reducing errors from handwritten prescriptions. 4. Health Wearables: Devices approved by the FDA monitor vital signs, providing accurate data for timely interventions and better clinical decisions. 5. Remote Patient Monitoring: Systems that allow healthcare providers to track health indicators remotely, supporting chronic illness management without frequent visits. 6. Telehealth Platforms: Approved telemedicine solutions facilitate virtual consultations and electronic prescriptions, increasing access to care in underserved areas. 7. Medication Adherence Tools: Technologies like smart pill bottles remind users to take medications, reducing missed doses and improving outcomes. These digital products enhance patient care, streamline workflows, and improve the healthcare experience. For inquiries, please visit REGULATORY DOCTOR at https://regulatorydoctor.us and contact Dr. David Lim at David@regulatorydoctor.us. Subscribe to the Caleb Strong Empowerment Channel @CalebStrongOfficial for life empowerment tips.

EndeavorRx® is a digital therapeutic indicated to improve attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. Patients who engage with EndeavorRx demonstrate improvements in a digitally assessed measure, Test of Variables of Attention (TOVA®), of sustained and selective attention and may not display benefits in typical behavioral symptoms, such as hyperactivity. EndeavorRx should be considered for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder. The most common side effect observed in children in EndeavorRx clinical trials was a feeling of frustration, as the game can be quite challenging at times. No serious adverse events were observed with its use. Featured families were actual users of EndeavorRx, compensated for their participation and feedback. Testimonials provided are voluntary and personal to the family featured. EndeavorRx results and experiences may vary. For EndeavorRx Indications and Safety information, visit: endeavorrx.com/regulations.