ActiGraph’s Post

🚨🚨🚨 Last call to register! Our FREE public meeting led by FDA and the Digital Medicine Society (DiMe) starts tomorrow! Join us on June 26 and June 27, from 11 a.m. to 3 p.m. ET each day. We’ll explore how patient-generated health data (PGHD) can advance remote clinical trial #data collection and facilitate high-quality clinical outcome assessment. 👥 During this 2-day public meeting, 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 🔗 Register today and join us 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://lnkd.in/ej93__-2 AbbVie ActiGraph Advanced Research Projects Agency for Health (ARPA-H) Bellerophon Therapeutics Clario COPD Foundation Empatica Evidation FasterCures FDA Google HITea With Grace Jackson Heart Study, Koneksa Medable, Inc The Michael J. Fox Foundation for Parkinson's Research National Organization for Rare Disorders Netherlands Organisation for Applied Scientific Research TNO The Light Collective Tidepool Verily VivoSense, Inc. Walgreens Boots Alliance White House Office of Science and Technology Policy WHOOP

🎉 We are excited to announce a FREE 2-day public meeting led by FDA and the Digital Medicine Society (DiMe) on June 26, 11 a.m. – 3 p.m. ET, and June 27, 11 a.m. – 3 p.m. ET. During this meeting, we will explore how patient-generated health data (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 🔗 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

The Steering Committee Meeting Materials from Wednesday have been uploaded. Noor Falah, MS thanks so much. Here is the link: https://lnkd.in/eVVS53qt. Also big thanks to everyone for participating: Brandon Gallas S. Joseph Sirintrapun Kevin Schap and so many more. See you next months on April 24th 2024 – 3PM EST If you want to join the community: https://lnkd.in/e-Kec5ZT Briefly, PIcc is a regulatory science initiative that aims to facilitate innovations in pathology as well as advance safety and effectiveness evaluation, and to harmonize approaches to speed delivery to patients using collaborative, pre-competitive approaches. The collaborative community (PIcc) is open to all stakeholders, public or private, including, but not limited to, academia, industry, health care providers, patients and advocacy groups. A collaborative community is a continuing forum in which all stakeholders, public and private, alongside the FDA, work together on regulatory science questions and medical device challenges to achieve common objectives.  The Pathology Innovation Collaborative Community (PIcc) has achieved recognition as a collaborative community with participation by the FDA.  Participation in collaborative communities is one of the FDA’s Center for Devices and Radiological Health’s (CDRH) strategic priorities.  #PathologyInnovationCollaborativeCommunity #PICC Medical Device Innovation Consortium (MDIC)

🤔 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

❓ Do you want to participate in a unique opportunity to learn alongside industry leaders and contribute to future FDA and DiMe work on resources to advance the use of patient-generated health data (PGHD) in #clinical research and regulatory science? 📅 Then 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. DiMe and FDA will use the information and insights shared during the public meeting to: ▪️ Gather case examples to demonstrate how PGHD can be implemented throughout the total product life cycle (TPLC) ▪️ Explore ways to use PGHD to help advance remote clinical trial data collection and support clinical outcome assessments ▪️ Demonstrate how PGHD can highlight the patient voice in the medical device ecosystem 🔗 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://lnkd.in/emf5MCr5

Big moment for the use of digital endpoints in clinical trials. Great to see the progress being made but still so much more opportunity! #digitalendpoints #clinicaltrials #eCOA #patientreportedoutcomes

I’m excited to speak at next week’s free, 2-day public meeting led by FDA and the Digital Medicine Society (DiMe)!  During this meeting, we will explore how patient-generated health data (PGHD) can advance remote clinical trial #data collection and facilitate high-quality clinical outcome assessment. I will share my personal patient journey with diabetes and hope you’ll join to hear my session: 📣 What's your Type? Digital Health Technologies has Got Diabetes Covered  📅 Thursday, June 27 🕛 12pm ET By attending the full meeting, you will also 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 🔗 Register today for this unique opportunity to learn alongside other industry leaders and contribute to future work on resources to advance the use of PGHD in #clinical research and regulatory science. Register here: https://lnkd.in/gCMv362m

🚨 🚨 FDA has qualified the first digital biomarker for use in clinical trials! 🚨 🚨 Here are the details: 🍏 The Apple AFib History Feature was qualified through FDA's Medical Device Development Tools (MDDT) program ⌚ This digital biomarker evaluates estimates of AFib Burden 🔬 It is qualified as a secondary efficacy endpoint in clinical trials of cardiac ablation devices So what does this mean?! The MDDT Program has emerged as the dark horse for the long-awaited big win for digital clinical measures in clinical trials. The FDA's acceptance of digitally measured moderate to vigorous physical activity (MVPA) as the primary endpoint in Bellerophon Therapeutics' Phase 3 clinical trial of INOpulse® for treatment of Fibrotic Interstitial Lung Disease signaled regulatory embrace of high-value, high-quality digital endpoints. But when that therapy didn't perform, the regulatory breakthrough was overshadowed. Today is a straight-up win for all of us that believe in the promise of sensor-based digital health technologies (sDHTs) to transform the way we develop new medical products to better serve the patients our industry exists to serve. Onwards! 🚀 --- If you want to learn more about FDA's MDDT Program and the first qualified digital biomarker (woot!) click here 👉 https://lnkd.in/eN9sRDUK If you want to keep up to date with the first trials to deploy this new endpoint, bookmark The Digital Medicine Society (DiMe)'s library of digital endpoints, update quarterly 👉 https://lnkd.in/eWka-sr4 #digitalhealth #digitalbiomarker #clinical trials

We are a team of 🔝 professionals dedicated to providing professional services in the field of clinical trials of medical devices and in vitro diagnostic medical devices for the medical industry on a daily basis. With our partners in mind, we have prepared a holiday educational series in which we explain the basic issues related to our industry. Today, Katarzyna Kozłowska explains what the trial monitoring process is all about. In addition, you will learn what is the head purpose of such an activity and who is responsible for the process. You need to know that throughout the survey, it is necessary to periodically review the documentation and verify the quality of the results obtained. We encourage you to watch 📽 our next episode. --- 🔝 Jesteśmy zespołem fachowców, którzy na co dzień zajmują się dostarczaniem profesjonalnych usług z zakresu badań klinicznych wyrobów medycznych i wyrobów medycznych do diagnostyki in vitro dla branży medycznej. Z myślą o naszych partnerach przygotowaliśmy wakacyjny cykl edukacyjny, w którym wyjaśniamy podstawowe kwestie dotyczące naszej branży. Dziś Katarzyna Kozłowska tłumaczy na czym polega proces monitorowania badania. Oprócz tego, możecie się dowiedzieć jaki jest głowy cel takiego działania i kto jest odpowiedzialny za ten proces. Musicie wiedzieć, że podczas trwania całego badania, należy dokonywać cyklicznego przeglądu dokumentacji oraz weryfikacji jakości uzyskanych wyników. Zachęcamy do objerzenia naszego kolejnego odcinka. 📽 #PureClinical #MDR #IVDR #medicaldevice #medicaldevices

Another great step for the #digitalmedicine field - the first digital biomarker qualified under FDA's new MDDT program (similar to the drug development tools DDT program). Interesting read - the actual qualification doc (https://lnkd.in/eREwAeW4). Look forward to more digital biomarkers and digital endpoints to be qualified by FDA and other regulatory bodies!