Global medical device and diagnostic expertise

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title="Obesity_MDD.jpg" /> </div> </div> </div> <span class="h4">Obesity</span> <p class="section-overview--desktop">A focus on combination therapies requires appropriate obesity-specific trial designs, long-term follow-up studies and diverse patient recruitment.</p> </a> </div> <div class="col-xl-3"> <a href="/insights/therapeutics" class="dropdown-item dropdown-item--with-image"> <div class="image image--zoom-on-hover"> <div><div><img src="https://icon.widen.net/content/78559377-8cc3-4bc6-b6f2-cc20a04e1504/web/cells-menu-hero.jpg?crop=yes&w=260&h=136&itok=750H7OG2" width="260" height="136" alt="cells-menu-hero.jpg" loading="eager" title="cells-menu-hero.jpg" /> </div> </div> </div> <span class="h4">Therapeutics insights</span> <p class="section-overview--desktop">ICON's therapeutic experts contribute regularly to industry publications and the creation of thought leadership content. 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efficient; the methods and technologies advancing Alzheimer’s and Parkinson’s R&D</span> <p class="section-overview--desktop">In this CNS whitepaper we examine how innovative methodologies and technologies are being implemented to improve the success rate of neurodegenerative clinical trials.</p> </a> </div> <div class="col-xl-3"> <a href="/sectors/biotech/early-phase-challenges-biotechs" class="dropdown-item dropdown-item--with-image"> <div class="image image--zoom-on-hover"> <div><div><img src="https://icon.widen.net/content/fc13f816-bd06-455c-a1ae-4daf6cb35f40/web/Thumbnail_biotech_whitepaper.jpeg?crop=yes&w=260&h=136&itok=XglqHZSI" width="260" height="136" alt="Early phase challenges for biotechs_whitepaper" loading="eager" title="Early phase challenges for biotechs_whitepaper" /> </div> </div> </div> <span class="h4">Early phase challenges for biotechs</span> <p class="section-overview--desktop">Approaching early phase trials strategically and anticipating obstacles can be critical to the later success of a therapeutic</p> </a> </div> <div class="col-xl-3"> <a href="/insights/regulatory-intelligence/exploring-fda-guidance-modern-data-monitoring-committees" class="dropdown-item dropdown-item--with-image"> <div class="image image--zoom-on-hover"> <div><div><img src="https://icon.widen.net/content/eaa349ef-9f6c-4c5c-b00f-e90cfc4bbedf/web/MDD_FDA_guidance_DMC.jpg?crop=yes&w=260&h=136&itok=KqupIbhv" width="260" height="136" alt="MDD_FDA_guidance_DMC.jpg" loading="eager" title="MDD_FDA_guidance_DMC.jpg" /> </div> </div> </div> <span class="h4">Exploring FDA guidance for modern Data Monitoring Committees</span> <p class="section-overview--desktop">What you need to know for compliant, efficient safety and efficacy monitoring</p> </a> </div> </div> </div> </div> </li> <li class="nav-item dropdown"> <a href="/news-events" aria-expanded="false" class="nav-link dropdown-toggle" data-toggle="dropdown" role="button"> News & Events <span></span> </a> <div 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March 2025</p> </a> </div> </div> </div> </div> </li> <li class="nav-item dropdown"> <a href="/about" aria-expanded="false" class="nav-link dropdown-toggle" data-toggle="dropdown" role="button"> About ICON <span></span> </a> <div class="menu_link_content menu-link-contentmain view-mode-main-navigation dropdown-menu"> <button class="navbar-btn navbar-btn--back" type="button"> <span class="navbar-btn__icon"></span> </button> <div class="container-fluid container-fluid--xl"> <div class="row"> <div class="col-xl-3"> <div class="paragraph paragraph--type--mega-menu-text paragraph--view-mode--default"> <div class="mega-menu-title"><a href="/about" target="_self">About ICON</a></div> </div> <a class="dropdown-item" href="/about/company-history">Company history</a> <a class="dropdown-item" href="/about/icon-glance">ICON at a glance</a> <a class="dropdown-item" href="/about/healthcare-intelligence">Healthcare Intelligence</a> <a class="dropdown-item" href="/about/icon-in-asia-pacific">ICON in 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</div> </div> </div> </div> </a> </div> <div class="col-sm"> <a href="/solutions/consulting/regulatory-affairs/medical-devices-ivd" class="block-link" target="_self"> <div class="container-full"> <div class="card card--title-description card--title-description-purple text-left"> <div class="card-body" data-mh="card-body"> <i class="icon-ui-arrow-right"></i> <h4 class="card-title">Regulatory Affairs & Quality Assurance</h4> <div class="card-text small"> <div> <p>Our regulatory and quality experts have extensive experience in working with medical devices, in-vitro diagnostics (IVDs), companion diagnostics and combination drug-device products and will help you achieve compliance in your chosen market(s) quickly and cost effectively.</p> </div> </div> </div> </div> </div> </a> </div> </div> </div> </div> </div> <div id="6b4be82b-81ec-44f8-b38a-e438d4e0403f"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper "> <div class="row"> <div class="col-sm"> <div 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transition extension: What changes do you need to know about?</h4> <div class="card-text small"> <div> <p>Read this briefing document to understand the MDR amendment, including transition period extension and conditions and the current status of IVDR.</p> <p> </p> </div> </div> </div> </div> </div> </a> <a href="https://drug-dev.com/injection-technology-patient-centricity-in-insulin-injection-using-technology-to-improve-self-administration/" class="block-link carousel__item" target="_blank"> <div class="container-full"> <div class="card card--overlapping-img text-left card--overlapping-img-gray-light"> <div class="image image--zoom-on-hover"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/z8x4hyjsur/web/flex-advantage.jpg?crop=yes&w=470&h=246&a=0,47&itok=joJnc-6Y 1x, https://icon.widen.net/content/z8x4hyjsur/web/flex-advantage.jpg?crop=yes&w=470&h=246&a=0,47&itok=Klzc6tBf 2x" media="(min-width: 1400px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/z8x4hyjsur/web/flex-advantage.jpg?crop=yes&w=470&h=246&a=0,47&itok=joJnc-6Y 1x, https://icon.widen.net/content/z8x4hyjsur/web/flex-advantage.jpg?crop=yes&w=470&h=246&a=0,47&itok=Klzc6tBf 2x" media="(min-width: 1200px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/z8x4hyjsur/web/flex-advantage.jpg?crop=yes&w=470&h=247&a=0,47&itok=HiOdILkR 1x, https://icon.widen.net/content/z8x4hyjsur/web/flex-advantage.jpg?crop=yes&w=470&h=325&a=0,8&itok=FaLt52ct 2x" media="(min-width: 992px) and (max-width: 1199px)" width="301" height="158"/> <source srcset="https://icon.widen.net/content/z8x4hyjsur/web/flex-advantage.jpg?crop=yes&w=470&h=245&a=0,48&itok=ckfaRFKS 1x, https://icon.widen.net/content/z8x4hyjsur/web/flex-advantage.jpg?crop=yes&w=470&h=245&a=0,48&itok=AXDn_fqi 2x" media="(min-width: 768px) and (max-width: 991px)" width="226" height="118"/> <source srcset="https://icon.widen.net/content/z8x4hyjsur/web/flex-advantage.jpg?crop=yes&w=470&h=247&a=0,47&itok=k__SghRO 1x, https://icon.widen.net/content/z8x4hyjsur/web/flex-advantage.jpg?crop=yes&w=470&h=247&a=0,47&itok=qkbIrGP2 2x" media="(min-width: 576px) and (max-width: 767px)" width="400" height="210"/> <source srcset="https://icon.widen.net/content/z8x4hyjsur/web/flex-advantage.jpg?crop=yes&w=470&h=247&a=0,47&itok=rjr9CYbY 1x, https://icon.widen.net/content/z8x4hyjsur/web/flex-advantage.jpg?crop=yes&w=470&h=247&a=0,47&itok=Fs_xYyyH 2x" media="(max-width: 575px)" width="400" height="210"/> <img src="https://icon.widen.net/content/z8x4hyjsur/web/flex-advantage.jpg?crop=yes&w=470&h=247&a=0,47&itok=rjr9CYbY" width="400" height="210" alt="flex-advantage" title="flex-advantage" loading="lazy" /> </picture> </div> </div> </div> <div class="card-body overlapping-comp" data-mh="card-body"> <i aria-hidden="true" class="icon-ui-arrow-right"></i> <h4 class="card-title">Patient centricity in 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data-mh="card-body"> <i aria-hidden="true" class="icon-ui-arrow-right"></i> <h4 class="card-title">The IVDR Journey</h4> <div class="card-text small"> <div> <p>A roadmap to meet 2022 deadlines, while navigating pandemic disruptions</p> </div> </div> </div> </div> </div> </a> <a href="/insights/digital-disruption/mHealth-wearables/cybersecurity" class="block-link carousel__item" target="_self"> <div class="container-full"> <div class="card card--overlapping-img text-left card--overlapping-img-blue"> <div class="image image--zoom-on-hover"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/emeagj7gop/web/cybersecurity-carousel.jpg?crop=yes&w=400&h=210&a=0,1&itok=9nuAzKyc 1x, https://icon.widen.net/content/emeagj7gop/web/cybersecurity-carousel.jpg?crop=yes&w=400&h=210&a=0,1&itok=UvmAjiTk 2x" media="(min-width: 1400px)" width="370" height="194"/> <source 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class="icon-ui-arrow-right"></i> <h4 class="card-title">Addressing Cybersecurity for your Medical Device</h4> <div class="card-text small"> <div> <p>Cybersecurity vulnerabilities can emerge in any medical device that can be connected to another electronic device or network.</p> </div> </div> </div> </div> </div> </a> <a href="/insights/blog/2020/08/20/iso-14155-medical-device-regulations" class="block-link carousel__item" target="_self"> <div class="container-full"> <div class="card card--overlapping-img text-left card--overlapping-img-blue"> <div class="image image--zoom-on-hover"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/zydzbztbil/web/doctor-with-tablet.jpg?crop=yes&w=370&h=194&a=0,88&itok=gL2zTTRt 1x, https://icon.widen.net/content/zydzbztbil/web/doctor-with-tablet.jpg?crop=yes&w=370&h=194&a=0,88&itok=5QRQR9MT 2x" media="(min-width: 1400px)" width="370" height="194"/> <source 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src="https://icon.widen.net/content/o6hv3tpk9a/web/r-and-d-model.jpg?crop=yes&w=400&h=210&a=0,1&itok=b5qqg1ww" width="400" height="210" alt="r-and-d-model" title="r-and-d-model" loading="lazy" /> </picture> </div> </div> </div> <div class="card-body overlapping-comp" data-mh="card-body"> <i aria-hidden="true" class="icon-ui-arrow-right"></i> <h4 class="card-title">Transforming the R&D Model to sustain growth</h4> <div class="card-text small"> <div> <p>Read the white paper, Transforming Medical Device Development: Achieving challenging mandates for cost savings and pipeline productivity, to unlock key strategies for maximising value from your strategic partnerships.</p> </div> </div> </div> </div> </div> </a> <a href="/insights/value-based-healthcare/cardiovascular-medical-devices" class="block-link carousel__item" target="_self"> <div class="container-full"> <div class="card card--overlapping-img text-left card--overlapping-img-gray-dark"> <div class="image image--zoom-on-hover"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/nenzxuoamh/web/uuid_710f087f-4ec4-4c1a-9ef7-f33261fb7c7f_cardiovascular.jpg?crop=yes&w=400&h=210&a=0,2&itok=zKtN3qWJ 1x, https://icon.widen.net/content/nenzxuoamh/web/uuid_710f087f-4ec4-4c1a-9ef7-f33261fb7c7f_cardiovascular.jpg?crop=yes&w=400&h=210&a=0,2&itok=mDLStNCc 2x" media="(min-width: 1400px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/nenzxuoamh/web/uuid_710f087f-4ec4-4c1a-9ef7-f33261fb7c7f_cardiovascular.jpg?crop=yes&w=400&h=210&a=0,2&itok=zKtN3qWJ 1x, https://icon.widen.net/content/nenzxuoamh/web/uuid_710f087f-4ec4-4c1a-9ef7-f33261fb7c7f_cardiovascular.jpg?crop=yes&w=400&h=210&a=0,2&itok=mDLStNCc 2x" media="(min-width: 1200px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/nenzxuoamh/web/uuid_710f087f-4ec4-4c1a-9ef7-f33261fb7c7f_cardiovascular.jpg?crop=yes&w=400&h=210&a=0,2&itok=gBYIm3rz 1x, 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