Orthopaedic Research and Education Foundation的动态

This week, our CSO, Amin Rostami-Hodjegan, participated in the “Executive Roundtable” at Avicenna Day 2024, hosted by the Avicenna Alliance. This prestigious annual event brings together industry and academic leaders to drive innovation in in silico medicine. Amin shared his insights alongside experts like Mark Palmer, M.D., Ph.D. (Ansys), Jan Hertwig (Simq GmbH), Jean Colombel (Dassault Systèmes), and Martha De Cunha Maluf-Burgman (Edwards Lifesciences), with moderation by Thierry Marchal (Avicenna Alliance/Ansys). He discussed the counter-intuitive philosophies related to transitioning modeling and simulation from academic endeavors to industrial tools and regulatory assessments. Key topics included the challenges of using open-source codes for regulatory purposes and the acceptance of models when no alternatives exist. The panel explored the transformative impact of digital simulations on medicine and technology, and how in silico medicine can bridge the gap between the scientific community, industry, and policymakers. For more on the Avicenna Alliance and the importance of integrating modeling and simulation into broader scientific practice, check out this article: https://ow.ly/XcLo50TfOtu, and visit: https://ow.ly/MnPS50TfOtt. #Innovation #InSilicoMedicine #AvicennaDay2024 #DigitalHealth #ModelingAndSimulation #PharmaTech

?? Breaking: Boston Scientific's Advanced PFA Catheter Gets FDA Green Light TL;DR: Boston Scientific's latest pulsed field ablation catheter with enhanced navigation capabilities has secured FDA approval, marking a significant advancement in cardiac arrhythmia treatment. ?? Industry Impact: This milestone signals a pivotal shift in biotech, where navigation tech meets therapeutic innovation. The integration sets new standards for precision medicine and opens fresh market opportunities. ?? Strategic Takeaways: ? Consider tech partnerships to enhance device capabilities ? Explore research collaborations focused on precision ? Streamline regulatory compliance strategies ? Prioritize innovation in device usability The future of medical devices clearly lies at the intersection of precision technology and therapeutic effectiveness. What's your take on this trend? Are you seeing similar technology integration opportunities in your field? Let's discuss below. ?? #Biotech #MedicalDevices #Innovation #HealthTech #FDA

Mediplus unveils 'groundbreaking' 5-way TIVA Set Mediplus, a leader in medical device innovation, has unveiled its pioneering 5-Way TIVA Set at SIVA 2024, the annual scientific meeting hosted by The Society for Intravenous Anaesthesia. via Med-Tech Innovation News | Home

The Medical Device and Diagnostic Innovation Cluster (MeDDIC), under the auspices of the South African Medical Research Council (SAMRC), is pleased to invite you to join us for the first Medical Devices Stakeholder Forum (MDSF) meeting for 2024. The MDSF is aimed at facilitating dialogue in the medical devices and diagnostics sector and will cover a wide range of topics ranging from Regulatory, Funding, Skills Development and Value chain(s).?This is one of the tools we would like to re- introduce post the conclusion of the Medical Technology Masterplan to help achieve MeDDIC’s mission towards developing a vibrant, cohesive ecosystem in which stakeholders co-operate and collaborate to seamlessly design, develop, manufacture and commercialize medical devices with a significantly increased local content and thereby contributing to the sector and broader economic development.” The topics for the upcoming discussion will include but are not limited to challenges and opportunities in regulatory, reimbursement and procurement of medical devices and diagnostics. Please join us and share your experience and possible recommendations to help us build a more cohesive ecosystem.?

??#Lab_facts by NABI | Fact no. 13 When testing medical devices, Hemocompatibility is crucial, especially for those in contact with blood—but here’s a surprising fact: ?? Hemocompatibility testing not only assesses how materials interact with blood but also how they might trigger blood clotting or destroy blood cells. What’s intriguing is that even tiny particles shed by a device can cause significant blood reactions, making this test essential for ensuring device safety and efficacy! At NABI, we rigorously conduct Hemocompatibility tests to ensure that your medical devices meet the highest standards of safety, particularly for cardiovascular and blood-contacting applications. Stay tuned for more #Lab_facts as we uncover the science behind medical device safety! ______________________________________ #NABI #Lab_facts #nabiLab_facts #laboratory #experiments #biocompatibility #Hemocompatibility #medicaldevices

Very insightful with lots of important practical regulatory tips for developing and launching a biomedical product!

?? Join us for an insightful NAMSA session on designing clinical trials for Software as a Medical Device (SaMD)! ?? In this session, we'll cover two major points: ?? Valid Clinical Association: Ensuring the device's outputs align with clinical needs, sometimes requiring prospective data collection. ?? Clinical Validation: Demonstrating the device's performance in its intended use population, including sensitivity, specificity, and overall impact on the user. Using examples like ultrasound diagnostics, we'll explore how to show regulators and users that your SaMD meets the necessary performance standards. Don't miss out on this opportunity to enhance your understanding of SaMD clinical trials! https://lnkd.in/gFhBG_Cm #ClinicalTrials #SaMD #MedicalDevices #NAMSAKnows

Seamless Connectivity with Inventus Connect Global eSIM Technology – Connecting the World Inventus Connect global eSIM technology bridges connectivity gaps in clinical trials, enabling secure, reliable device access across borders. Our devices make clinical trials easier and more accessible, connecting patients and researchers like never before. Let’s push the boundaries of what’s possible in clinical research! Have questions or want to learn more? Speak with our team of experts to explore how Inventus can transform your clinical trial operations. Email us at [email protected] Discover New Possibilities Together! #eSIMTechnology #GlobalConnectivity #InventusInnovation #ClinicalTrials #ClinicalResearch #ePRO #eCOA #TrialSolutions #DeviceInnovation #HealthTech #Innovation

Today we published the results of our proof of principle study with BioReBone. The conclusion of this study was: Within the limitations of the current clinical trial, we found that ErhBMP-2/BioCaP/β-TCP could be considered as an osteopromotive and biocompatible bone substitute. This novel bone substitute can potentially achieve safe and effective treatment for repairing bone defects. The product has been developed in full compliance with the current international standards for the development of medical devices. If you are interested in more information do not hesitate to contact me. file:///Users/Herman/Downloads/J%20Clinic%20Periodontology%20-%202024%20-%20Wei%20-%20The%20Clinical%20Efficacy%20and%20Safety%20of%20ErhBMP%E2%80%902%20BioCaP%20%20%E2%80%90TCP%20as%20a%20Novel%20Bone%20Substitute.pdf

?? Exciting Milestone?? We are thrilled to announce that the Randomized Controlled Trial (RCT) BIOMAG-II has surpassed 300 enrollments! This significant milestone brings us closer to advancing medical innovation and improving patient care. Learn more about #Freesolve RMS – Metallic performance. Fully resorbable. ?? https://ow.ly/xPwI50UMoN8 #BIOTRONIK #VI #RMS #Leavenothingbehind #PCI #WhatWouldYouChoose