Digital Medicine Society (DiMe)

🚨 NEW project announcement! 🚨 💪 Digital endpoints can potentially revolutionize clinical trials - but only if we continue to do the work to prove their value. By leveraging digital endpoints, clinical trials can be more patient-centric, data-driven, and adaptable to meet the evolving needs of healthcare research. And while digital endpoints' potential is undeniable, widespread adoption remains a challenge. 🌐 DATAcc by DiMe’s new project, “Building the Business Case for Digital Endpoints,” will establish effective measures to monitor and benchmark the value of digital endpoints, aiming to help organizations build a compelling case for continued investment in digital strategies aligning with business goals and industry standards. This team will develop resources that: ▪️ Establish shared industry benchmarks for assessing the ROI of digital endpoints in drug development, medical device innovation, and other regulated interventions ▪️ Support organizations in building the business case for digital endpoints to facilitate the advancement, implementation, and widespread adoption of fit-for-purpose digital measures as endpoints in clinical trials ▪️ Help organizations make informed decisions and sustain investment in integrating digital endpoints into digital health strategies 🤝 Together, we must build the business case for digital endpoints so organizations can make informed decisions about integrating them into digital health strategies. This will improve patient care, operational efficiency, and overall success in the evolving digital health landscape! 🔎 Learn more here: https://lnkd.in/ej6YnfSi If you missed partnering on this project, don't worry! We have exciting projects kicking off this year. More information in the comments! ⬇️ AbbVie ActiGraph Biofourmis CHEO Research Institute Chugai Pharma USA, Inc. COPD Foundation Cosinuss GmbH Critical Path Institute (C-Path) Cumulus Neuroscience Eastern Virginia Medical School Evinova FDA Genentech Imperial College London Koneksa Merck Mitsubishi Tanabe Pharma America Mobilise-D OmniScience Roche Sama Therapeutics Strados Labs SYSNAV #TechDoctor TNO Tufts Center for the Study of Drug Development The University of Chicago Pritzker School of Medicine VeriSIM Life WKD.SMRT Regeneron Brain&Mind BlueSkeye AI VivoSense, Inc. Modality.AI Sanofi Health Advances

🎗️ In the fight against breast cancer, early and accurate detection is critical. While traditional 2D mammography has been a staple in breast cancer screening, advancements in technology have opened the door to 3D imaging. 🔬 Lunit Cancer Screening, a pioneering company in AI-powered medical imaging, has been at the forefront of using innovation to detect early-stage cancer and optimize treatment. Responding to the rising demand for advanced diagnostic methods in the U.S., Lunit embarked on an ambitious journey to develop a state-of-the-art 3D breast cancer screening AI solution. 🖥️ Lunit INSIGHT DBT aims to provide quicker and more accurate diagnoses than conventional 2D imaging can offer. 📈 Lunit’s regulatory strategy included engaging with the FDA early on and leveraging lessons learned from previous submissions. This collaborative effort enabled Lunit to align with the agency's expectations and develop a comprehensive 510(k) submission package. 🚀 Lunit INSIGHT DBT is now poised to revolutionize the breast screening market, offering faster and more accurate breast cancer diagnoses that will save patient lives. 💡 Learn more about Lunit’s regulatory journey here: https://lnkd.in/esZPrq2V

Digital health technologies (DHTs) have increasingly become optimal instruments for objectively evaluating patient status regarding Alzheimer’s disease and related dementias (ADRD). DHTs can be used as screening tools or diagnostic aids to monitor symptoms and disease progression or as measurement tools in clinical trials and research. 🎉 We are thrilled to share that DATAcc by DiMe recently published a comprehensive landscape review in Springer Nature Group's, The Journal of Prevention of Alzheimer’s Disease! “Digital Health Technologies for Alzheimer’s Disease and Related Dementias: Initial Results from a Landscape Analysis and Community Collaborative Effort,” identifies over 100 digital health technologies (also included in DATAcc by DiMe’s Library of Digital Measurement Products) being used for assessment and monitoring in ADRD populations. 🤝 This multi-stakeholder collaborative effort, involving experts from academia, industry, clinical practice, and patient advocacy groups, surveyed 20 years of peer-reviewed literature and community input to catalog technologies like wearable sensors, smartphone/tablet apps, smart home setups, and more. Key Findings: 📱Mobile apps and ambient sensors were most prevalent, enabling remote cognitive, functional, and behavioral assessment outside the clinic. 🧠 Neurocognitive functions like memory were frequently evaluated, but technologies also captured sleep, physical activity, speech, and mobility patterns. 🔬 We captured clinical validation results for 69% of identified technologies, demonstrating real-world use and applicability. The results highlight digital health's vast potential for enabling earlier detection, better monitoring, and more sensitive measurement of symptoms and progression in Alzheimer's and related dementias. Altoida, Inc. VivoSense, Inc. Merck Cumulus Neuroscience Eli Lilly and Company Linus Health Eisai US 📚 Read the full open-access publication: https://bit.ly/3xbPE9Q

📅 We are one week away from HLTH Europe! As part of the DiMe community, you can register today for €150 off! Use coupon code HE24_Digital150 https://lnkd.in/eAMA7B-t 🌐 Don't miss the Partner Program on Monday, June 17, from 14:00 - 16:00 CEST. Experts from DiMe’s International Digital Health Regulatory Pathways initiative will lead a series of discussions centered on existing market landscapes, real-world case study experience, and long-term implications for DHT companies and policymakers. 📚 Learn more about the initiative here: https://lnkd.in/g64fZD8z 👏 Given the overwhelming interest and turnout we've seen in our past events, including packed sessions at HLTH Las Vegas with standing-room only, we're anticipating another high-energy and engaging experience. Be a part of these groundbreaking conversations during HLTH Europe, happening June 17-20, 2024! We hope to see you all there!

📅 Join Us Tomorrow at 11:00 a.m. ET for the Next Session of Our Webinar Series: "Digital Measurement of Nocturnal Scratch: New Developments" 🌐 In this webinar, we'll showcase the latest updates from technological research and development, showcasing the remarkable progress in the development of algorithms and tools designed to measure nocturnal scratch. Hear from industry experts: 🎙️ Wendy Smith Begolka, National Eczema Association 🎙️ Dina Katabi, Massachusetts Institute of Technology, Emerald Innovations 🎙️ Jaydev Thakkar, Biofourmis 🎙️ Steve Xu, Sibel Health 🎙️ Sylvain Zorman, ActiGraph 🔍 Be part of this vital discussion as we chart a course toward a future where digital measurements guide us toward a deeper understanding of patients' conditions and everyday experiences. https://lnkd.in/edQ6BMsG European Medicines Agency EMA National Eczema Association GSK Pfizer ActiGraph Massachusetts Institute of Technology Emerald Innovations Biofourmis DEEP Measures Takeda UCB Northwestern University Sonica Health Genentech Digital Medicine Society (DiMe)

🤔 Curious about how patient-generated health data (PGHD) can enhance medical device development? 📅 Join us at the FREE public meeting led by FDA and Digital Medicine Society (DiMe) on June 26, 11 a.m. – 3 p.m. ET, and June 27, 11 a.m. – 3 p.m. ET. Together, we’ll explore how PGHD can advance remote clinical trial #data collection and facilitate high-quality clinical outcome assessment. You will have the opportunity to learn about and discuss: ▪️ How to implement PGHD throughout the total product life cycle development of medical device development ▪️ Tangible case examples of how PGHD has informed medical devices and can improve return on investment ▪️ How PGHD can help improve health equity by promoting inclusivity in research studies ▪️ Case-based learning on the use of PGHD for medical device developers, scientists, and patients Don’t miss out! Register today for this unique opportunity to learn alongside industry leaders and contribute to future work on resources to advance the use of PGHD in clinical #research and regulatory science. 🔗 https://bit.ly/3K38K55

🌍 Millions of people worldwide suffer from debilitating neuromuscular conditions like stroke, chronic pain, pelvic health issues, and movement disorders. Traditional treatments often fall short, leaving patients searching for more effective solutions. 📚 In today’s case study, JOGO Health shares how it developed a groundbreaking approach to bringing relief to patients and how its regulatory strategy helped them do so. 🧠 JOGO's innovative therapy taps into neuroplasticity and retrains the brain and muscles to work together more effectively. This non-invasive, personalized treatment shows promise in helping patients regain function and improve their overall well-being. 🏥 Since engaging with the FDA, JOGO has successfully deployed its JOGO-GX product in health systems, ambulatory care clinics, and home settings. Their services are reimbursed by Medicare, major payers, and through self-insured company benefits and direct-to-consumer models. 🔍 Learn more about how JOGO navigated the regulatory landscape and payer reimbursement to bring their innovative neuromuscular re-education therapy to patients across the US: https://bit.ly/3wCG4wJ

🌐 Attending HLTH Europe this year? As part of the DiMe community, you can register today for €150 off! Use coupon code HE24_Digital150 https://lnkd.in/eAMA7B-t 📅 On Monday, June 17, from 14:00 - 16:00 CEST, join us for our engaging Partner Program. This panel will cover the opportunities and realities of developing a multi-market DHT evidence and commercial approach in Europe. Experts from DiMe’s International Digital Health Regulatory Pathways initiative will lead a series of discussions centered on existing market landscapes, real-world case study experience, and long-term implications for DHT companies and policymakers. Some featured speakers include: Miguel Amador, Complear; Jeroen Bergmann, University of Oxford; Megan Coder, Digital Medicine Society (DiMe); Anne Sophie Geier, Spitzenverband Digitale Gesundheitsversorgung; Bert Hartog, Digital Medicine Society (DiMe); Marisa Kaup, Oviva; Danny Jooyoung Kim, WELT corp; Bronwyn Le Grice, ANDHealth; John Mulcahy, S3 Connected Health; and Ariel Dora Stern, Universität Potsdam. Be a part of these groundbreaking conversations! 📚 Learn more about the initiative here: https://lnkd.in/g64fZD8z

🚨🚨🚨 Last chance to take advantage of DiMe’s special DiMe Bronze Sponsorship promotion! 🤝 If you join two new DiMe efforts by June 30 - including any project, coalition, education course development, and/or direct advisory - with a minimum spend of $100k, you’ll receive a Bronze Sponsorship package and benefits at no additional charge through the end of 2024! 🏆 DiMe Bronze Sponsorship packages include: ▪️ 3 DiMe sponsor credits per year (credits can be redeemed for various engagement activities) ▪️ 5 users for Digital Medicine Academy education courses ▪️ A custom sponsor landing page for your organization ▪️ Recognition of sponsorship on the DiMe website and select comms ▪️ Notification of new DiMe projects and resources prior to public launch 📧 Contact [email protected] to take advantage of this special offer today!

📅 Join us tomorrow at 11:00 a.m. ET for our "Digital Measurement of Nocturnal Scratch: New Developments" webinar series. The session will focus on the most recent regulatory feedback garnered through FDA's Critical Path Innovation Meeting forum and the EMA's Innovation Task Force (ITF) briefing meetings under the EMA pilot conducted with EFPIA - European Federation of Pharmaceutical Industries and Associations and DEEP Measures. Hear from industry experts: 🎙️ Dr. Thorsten Vetter, EMA 🎙️ Beth Kunkoski, FDA 🎙️ Matthew Diamond, FDA 🎙️ Carrie Northcott, Pfizer 🎙️ Michael Benecky, UCB 🎙️ Lada Leyens, DEEP Measures 🔍 Be part of this vital discussion as we chart a course toward a future where digital measurements guide us toward a deeper understanding of patients' conditions and everyday experiences. https://lnkd.in/edQ6BMsG European Medicines Agency EMA National Eczema Association GSK Pfizer ActiGraph Massachusetts Institute of Technology Emerald Innovations Biofourmis DEEP Measures Takeda UCB Northwestern University Sonica Health Genentech Digital Medicine Society (DiMe)