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Finally gave birth to this baby. It took me forever to get some more insight into what's going on with DTx in France. Thanks to Mathilde Pasko and DTx France© 2024 I got many answers. 🙄 Currently, there are 64 applications in the DiGA repository in Germany. By January 2024, six applications were removed due to various issues faced by the companies. 🤔 In 2023, France introduced the PECAN framework for the approval and reimbursement of digital solutions, including telemedicine and DTx. By June 2024, four solutions completed the approval process, with one solution for telemonitoring being approved. Three were rejected for various reasons, resulting in a 75% ⛔ rejection rate, as noted by Elsa Duteil at the DTx France 2024 conference in July. 😒 In the U.S. companies stopped waiting for reimbursement codes and are focusing on value-based care and innovation in business models. Why is progress with DTx so slow? In the latest Faces Of Digital Health Podcast newsletter I disect the history of digital therapeutics and where I believe the industry is at the moment. You will also find insights from Dorothée Marie-Louise Doepfer, Jessica Shull, Marko Kuisma, Galen Growth | Insights You Can Trust and podcasts with Andy Molnar, Digital Therapeutics Alliance, Amir Lahav, and Steven Vandeput, PhD. Enjoy the read by going through: ➡ First, a history lesson. ➡ The Challenge With Innovation in Healthcare ➡ Look at Belgium! ➡ Politics is Everything ➡ The reality check in 2024 ➡ What seems to be working? ➡ Now what? https://lnkd.in/dDHBpBcR #digitaltherapeutics #dtx #innovation #healthcare #apps #mobile #mentalhealth

Astellas Pharma partners with Desert Oasis Healthcare to pilot DIGITIVA™ a Digital Health solution for Heart Failure management: 🫀DIGITIVA aims to reduce acute heart failure events and hospital readmissions by providing at-home monitoring with real-time physician alerts based on critical biomarkers like low ejection fraction (LVEF). 🫀The solution integrates the CORE 500™ Digital Stethoscope by Eko Health and a smartphone app powered by Welldoc providing AI-driven personalized coaching and educational resources 🫀Clinicians receive tailored reports analyzing key cardioacoustic biomarkers aiming to enable earlier medical interventions and streamline decision making 🫀Patients using DIGITIVA can track heart health data, receive automated feedback, and access educational resources from the American Heart Association 🫀The pilot will evaluate its impact on clinical outcomes and cost metrics while collecting patient feedback to evaluate overall experience and quality of life measures 🫀DIGITIVA represents Astellas' first software-as-a-medical-device (SaMD) offering in the U.S. and Desert Oasis Healthcare is the first health system to implement it 💬DIGITIVA achieved FDA listing in September 2024, demonstrating Astellas’ focus on developing digital products alongside drugs through its Rx+® business accelerator. It's exciting to see this initiative gaining traction with health system(s) already 👇Link to articles in comments #DigitalHealth #AI #Pharma

The interactive walkway provides fit-for-purpose fall-risk biomarkers in the elderly: Comparison of zolpidem and suvorexant Clinical Trial Results: Interactive Walkway for Fall-Risk Biomarkers in the Elderly Key Findings: Study compared zolpidem and suvorexant in elderly subjects to assess the sensitivity of the Interactive Walkway (IWW) in measuring walking adaptability and fall risk. Results indicated that zolpidem led to decreased performance in walking adaptability, Timed-Up-and-Go test, and body sway, while suvorexant had minimal impact on IWW measurements. IWW successfully quantified the effects of the two drugs and showed sensitivity in assessing dynamic balance and potential fall risk in early clinical drug development. Practical Solutions and Value: Implementing AI-driven platforms like DocSym can consolidate clinical standards and research, making knowledge easily accessible for clinicians and enhancing treatment development. Mobile apps supporting scheduling, treatment monitoring, and telemedicine can streamline operations, manage patient care, and expand services digitally in today’s healthcare environment. AI can enhance clinic workflows, improve patient outcomes, and reduce routine paperwork, ultimately benefiting both healthcare providers and patients. Learn more about how we can help at aidevmd.com. https://lnkd.in/gACpU3xU #ClinicalTrials #AIinHealthcare #MedicalAI #HealthTech #DigitalHealth #PatientCareAI #AIResearch #MedicalInnovation #BioTech #AIforGood #HealthcareData #AIinMedicine #PharmaAI #ClinicalData #HealthAI #AIHealthSolutions #PrecisionMedicine #AIandHealth #ClinicalAnalytics #AIDiagnostics

I would like to share my specialization in Healthcare Marketplace. In this course, multiple aspects and agents of medical technology development and commercialization are described. This includes: - History and evolution of world trends in health market, stakeholders, and regulation administrations - Physician and hospital services as a functional and structural unit - Insurance market (with a deep take in USA model) - Medical technology market (regulatory, intellectual property, safety and effectiveness, and technology dossiers for marketing on a global scale), and - Global medical innovation and valuation I even performed a market sizing dossier for cardiac ablation technology regarding epidemiology and patients, ROI, commercial partners, hospital-tech dynamics, and how specific innovations disrupt the current state-of-the-art and marketplace of this type III medical devices cardiac therapy field.

Digital Self-Care - The future! Check out this interesting article by Stefanie Seiler, PhD and Ventsislav Dobrev from Ypsomed AG on ONdrugDelivery. Digital Health and Connected Drug Delivery Devices are going to become the norm very soon, as the use of it can save money, lives and time! Imagine your phone pinging every time you need to take your medication. you would never miss taking it again. Not sure how to administer the drug properly? log into your app to see how much of the medication and how to administer the drug delivery platform correctly Some devices for diabetes are also giving live data on glucose levels so you can take your insulin at precisely the right time. Read more in this article to see how Digital Health can and will transform the healthcare industry. #drugdelivery #digitalhealth #connectedhealth #pharmapackaging

PatientIQ Automates and Improves the Collection of Patient-Reported Outcome Measures | Healthcare IT Today - Healthcare IT Today #PatientIQ #Automates #Improves #Patient-Reported Outcome Measures PatientIQ is a platform that automates and enhances the collection of patient-reported outcome measures (PROMs) in healthcare settings. The platform allows healthcare providers to streamline the process of gathering data directly from patients, leading to more accurate and timely information for better decision-making. #Challenges in Collecting PROMs Traditionally, collecting PROMs has been a manual and time-consuming process for healthcare providers. PatientIQ addresses these challenges by offering a digital solution that simplifies data collection and analysis, ultimately improving the quality of care delivered to patients. #Benefits of Using PatientIQ By using PatientIQ, healthcare providers can save time and resources that would have been spent ai.mediformatica.com #healthcare #prom #proms #clinical #data #clinicaltrials #patients #clinicians #providers #datacollection #healthcareit #mattgitelis #digitalhealth #healthit #healthtech #healthcaretechnology @MediFormatica (https://buff.ly/3yMTgQx)

Positive effect of self-exercise following Botulinum toxin injection on the permanence of the recovery among the patients with HFS and BFS: A clinical trial Positive Effect of Self-Exercise Following Botulinum Toxin Injection on Recovery in HFS and BFS Patients: Clinical Trial ABSTRACT Botulinum toxin (BoNT) injection is the main treatment for hemifacial spasm (HFS) and blepharospasm (BFS). However, its long-term effectiveness is uncertain. This study investigates whether self-exercise after BoNT injection can prolong its effectiveness. METHODS 51 volunteers with HFS or BFS were split into 2 groups. Group 1 received detailed self-exercise instructions and were asked to perform the exercises 3 times a week for 1 week. The effectiveness of the treatment was assessed using hemifacial spasm grading scale (HSGS) and Jankovic scales. RESULTS Both groups were similar in demographics and disease severity. At the end of the first month, there was no significant difference between the groups. By the end of the third month, Group 1 maintained their improvement, while Group 2 saw most values return to baseline. CONCLUSION Facial self-exercise following botulinum toxin application may extend its effectiveness in HFS and BFS patients. Practical Solutions and Value Clinical trials are essential for developing safe treatments, and it’s crucial to apply their benefits in everyday medical practice. Our AI-driven platform, DocSym, consolidates clinical standards and research for easy access by clinicians. In today’s healthcare environment, streamlining operations is vital. Our mobile apps support scheduling, treatment monitoring, and telemedicine, simplifying patient care management and digital service expansion. By using AI, clinics can improve workflows, enhance patient outcomes, and reduce paper routines. Learn more about how we can help at aidevmd.com. https://lnkd.in/gsGXwDcW #ClinicalTrials #AIinHealthcare #MedicalAI #HealthTech #DigitalHealth #PatientCareAI #AIResearch #MedicalInnovation #BioTech #AIforGood #HealthcareData #AIinMedicine #PharmaAI #ClinicalData #HealthAI #AIHealthSolutions #PrecisionMedicine #AIandHealth #ClinicalAnalytics #AIDiagnostics

Effectiveness of treatment for concussion-related convergence insufficiency: The CONCUSS study protocol for a randomized clinical trial Effectiveness of Treatment for Concussion-Related Convergence Insufficiency: The CONCUSS Study Study Overview The CONCUSS study is a clinical trial that aims to compare two treatment approaches for concussion-related convergence insufficiency (CONC-CI). It will evaluate: Immediate Office-Based Vergence/Accommodative Therapy with Movement (OBVAM) Delayed OBVAM (starting six weeks later) The study will also explore how the timing of treatment and the number of therapy sessions (12 vs. 16) affect recovery. Who is Involved? The trial will enroll 100 participants aged 11-25 who have: A medically diagnosed concussion Persistent symptoms 4-24 weeks after injury Symptomatic convergence insufficiency What Will Happen? Participants will receive standard concussion care and be randomly assigned to one of the two treatment groups. After 7 weeks, their progress will be assessed based on: Near Point of Convergence (NPC) Positive Fusional Vergence (PFV) Symptom improvement After this assessment, the delayed group will start their therapy sessions, while the immediate group will have additional sessions. Key Features of the Study Clear definitions of conditions and outcomes Standardized diagnostic and treatment protocols Use of objective eye movement tracking and brain imaging This study aims to establish best practices for treating CONC-CI and understand how OBVAM works. Importance of Clinical Trials Clinical trials are essential for developing safe and effective treatments. Our AI-driven platform, DocSym, helps integrate clinical protocols and research into a user-friendly resource for healthcare providers. Enhancing Healthcare Delivery In today’s healthcare landscape, efficiency is vital. Our mobile apps facilitate: Scheduling Monitoring treatments Telemedicine services This simplifies patient care and expands digital services. Learn More Discover how we can support your clinic in improving workflows and patient outcomes at aidevmd.com. https://lnkd.in/g3-8dZxT #ClinicalTrials #AIinHealthcare #MedicalAI #HealthTech #DigitalHealth #PatientCareAI #AIResearch #MedicalInnovation #BioTech #AIforGood #HealthcareData #AIinMedicine #PharmaAI #ClinicalData #HealthAI #AIHealthSolutions #PrecisionMedicine #AIandHealth #ClinicalAnalytics #AIDiagnostics

Today we’re announcing the release of #Endobits Version 5, the latest iteration of our advanced, #AI-powered platform that’s paving the way for proactive #diabetes care. Endobits Version 5 is an Automated Remote Patient Management (ARPM) System that offers a comprehensive suite of tools for #healthcare providers and people with diabetes. For healthcare providers, Endobits v5 features an intuitive dashboard that performs an analysis of continuous glucose monitoring (CGM) data, prioritizes users by risk, gives helpful clinical suggestions, and assists with accurate charting. By streamlining the workflow and reducing administrative tasks, Endobits can help clinics improve their efficiency and reduce staff burnout. With the Endobits companion app, people with diabetes can increase their time-in-range, decrease their Hb A1c levels, and mitigate high-risk glycemic events. The app integrates with their CGM and gives personalized alerts, forecasts when high-risk events will happen, and provides helpful resources.   Learn more about how Endobits v5 can transform diabetes care at your clinic here: https://bit.ly/49G3saR #Diabetescare #Diabetesprevention #MachineLearning #AI #tech #valuebasedcare #remotepatientmonitoring

🙌 A big thank you to the Digital Therapeutics Alliance for their latest #report, which outlines how digital therapeutics (#DTx) can be integrated into the 🇺🇸 #healthcare system. The report provides valuable #insights on:   ➡️ reimbursement pathways  ➡️ defined roles for various stakeholders ➡️ a framework to improve consistency in enrolment for non-prescription DTx ➡️ actionable recommendations for both prescription and non-prescription models At 3.LIFE, we are encouraged by this alignment with our mission to transition from healthcare to life care. Through our products, #reACT🫀 #reSTABLE🧠, we are reshaping the dynamic between patients and healthcare providers ➡️ by personalising and streamlining care. #Empowering patients to take an active rol in managing their #health. #DigitalHealth #HealthTech #HealthInnovation #MarketAccess #MedTech #Reimbursement #PrecisionMedicine #Cardiology #ResearchLife #FDA #MedDev #Prescriptions #HealthCare #CareSupport #ECG #ClinicalTrials #PatientMonitoring #DataDriven #Submission #Compendia #PointOfCare