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Monday, March 17, 2025</div></section><div class="main-body page-taxonomies-show"><section class="taxonomy-header -has-one-topic "><div class="taxonomy-header__image-container"><section class="taxonomy-menu"><div class="taxonomy-menu__title-wrapper"><h1 class="taxonomy-menu__title">510(k)</h1></div></section></div></section><div id="breadcrumbs" class="breadcrumbs"><a class="" href="/">Home</a> » <a class="" href="/topics">Topics</a> » <a class="" href="https://www.bioworld.com/topics/402-regulatory">Regulatory</a> » 510(k)</div><section class="article-list-hz-l3 topic-featured-articles"> <ul class="article-list-hz-l3__items"> <li class="article-list-hz-l3__item"> <article class="article-list-hz-l3__article"><figure class="article-list-hz-l3__image "><a class="thumbnail-link" href="https://www.bioworld.com/articles/716938-us-fda-clears-roches-preeclampsia-test"><img class="article-list-hz-l3__image-thumb" loading="lazy" src="https://www.bioworld.com/ext/resources/Stock-images/Misc/Roche-building.jpg?height=355&t=1698088417&width=640" alt="Roche building" /></a></figure><div class="article-list-hz-l3__details -has-image"><div class="article-list-hz-l3__meta"><div class="article-list-hz-l3__post-date">Feb. 14, 2025</div><div class="article-list-hz-l3__author"><a class="article-list-hz-l3__author-link" href="/authors/126-annette-boyle"><span class="article-list-hz-l3__author-title-prefix">By </span><span class="article-list-hz-l3__author-name">Annette Boyle</span></a></div></div><h1 class="article-list-hz-l3__headline"><a class="article-list-hz-l3__article-title-link" href="https://www.bioworld.com/articles/716938-us-fda-clears-roches-preeclampsia-test">鈥婾S FDA clears Roche鈥檚 preeclampsia test</a></h1><div class="article-list-hz-l3__teaser">With rates of preeclampsia skyrocketing, the U.S. FDA鈥檚510(k) clearance of Roche Holding AG鈥檚 Elecsys test for preeclampsia offers some hope of reducing the number of women and infants who die or experience life-long consequences from the development of dangerously high blood pressure during late pregnancy and in the days immediately following delivery.</div></div></article> </li> <li class="article-list-hz-l3__item"> <article class="article-list-hz-l3__article"><figure class="article-list-hz-l3__image "><a class="thumbnail-link" href="https://www.bioworld.com/articles/716792-essilorluxottica-receives-us-eu-green-light-for-otc-audio-glasses"><img class="article-list-hz-l3__image-thumb" loading="lazy" src="https://www.bioworld.com/ext/resources/Stock-images/Therapeutic-topics/ENT/Hearing-loss-illustration.jpg?height=355&t=1738616487&width=640" alt="Hearing loss illustration" /></a></figure><div class="article-list-hz-l3__details -has-image"><div class="article-list-hz-l3__meta"><div class="article-list-hz-l3__post-date">Feb. 3, 2025</div><div class="article-list-hz-l3__author"><a class="article-list-hz-l3__author-link" href="/authors/599-shani-alexander"><span class="article-list-hz-l3__author-title-prefix">By </span><span class="article-list-hz-l3__author-name">Shani Alexander</span></a></div></div><h1 class="article-list-hz-l3__headline"><a class="article-list-hz-l3__article-title-link" href="https://www.bioworld.com/articles/716792-essilorluxottica-receives-us-eu-green-light-for-otc-audio-glasses">Essilorluxottica receives US, EU, green light for OTC Audio Glasses</a></h1><div class="article-list-hz-l3__teaser">Essilorluxottica SA received U.S. FDA clearance for its over-the-counter Nuance Audio Glasses, which combines sight and sound technologies, to help people improve their vision and hearing. The device also received a CE mark certification under the Medical Devices Regulation from the EU authorities.</div></div></article> </li> <li class="article-list-hz-l3__item"> <article class="article-list-hz-l3__article"><figure class="article-list-hz-l3__image "><a class="thumbnail-link" href="https://www.bioworld.com/articles/716154-inflammatixs-triverity-scores-fda-clearance-for-er-sepsis-test"><img class="article-list-hz-l3__image-thumb" loading="lazy" src="https://www.bioworld.com/ext/resources/BMT-source/2025/Inflammatix-Triverity-test-system-1-21.jpg?height=355&t=1737495377&width=640" alt="Inflammatix triverity test system 1 21" /></a></figure><div class="article-list-hz-l3__details -has-image"><div class="article-list-hz-l3__meta"><div class="article-list-hz-l3__post-date">Jan. 21, 2025</div><div class="article-list-hz-l3__author"><a class="article-list-hz-l3__author-link" href="/authors/126-annette-boyle"><span class="article-list-hz-l3__author-title-prefix">By </span><span class="article-list-hz-l3__author-name">Annette Boyle</span></a></div></div><h1 class="article-list-hz-l3__headline"><a class="article-list-hz-l3__article-title-link" href="https://www.bioworld.com/articles/716154-inflammatixs-triverity-scores-fda-clearance-for-er-sepsis-test">Inflammatix鈥檚 Triverity scores FDA clearance for ER sepsis test</a></h1><div class="article-list-hz-l3__teaser">Just a few weeks later than expected, Inflammatix Inc. secured U.S. FDA clearance of the Triverity test system for use in emergency triage of patients with suspected acute infection or sepsis. The molecular blood test is the first to identify bacterial and viral infections and provide an all-cause risk evaluation of the likelihood of developing severe illness.</div></div></article> </li> </ul><a class="article-list-hz-l3__more-link" href="/articles/topic/405">Read More</a> </section><section class="page-taxonomies-show__product-event-container "><section class="topic-authors "> <h1 class="topic-authors__title"><a class="topic-authors__title-link" href="/authors">Authors</a></h1><ul class="topic-authors__items"> <li class="topic-authors__item"> <div class="topic-authors__details"><a class="topic-authors__author-link" href="/authors/80-liz-hollis">Liz Hollis</a></div> </li> <li class="topic-authors__item"> <div class="topic-authors__details"><a class="topic-authors__author-link" href="/authors/21-mark-mccarty">Mark McCarty</a></div> </li> <li class="topic-authors__item"> <div class="topic-authors__details"><a class="topic-authors__author-link" href="/authors/172-meg-bryant">Meg Bryant</a></div> </li> <li class="topic-authors__item"> <div class="topic-authors__details"><a class="topic-authors__author-link" href="/authors/56-stacy-lawrence">Stacy Lawrence</a></div> </li> <li class="topic-authors__item"> <div class="topic-authors__details"><a class="topic-authors__author-link" href="/authors/13-nuala-moran">Nuala Moran</a></div> </li> <li class="topic-authors__item"> <div class="topic-authors__details"><a class="topic-authors__author-link" href="/authors/126-annette-boyle">Annette Boyle</a></div> </li> </ul><a class="topic-authors__more-link" href="/authors">More Authors</a> </section></section><div class="page-taxonomies-show__bottom-container"></div></div></div><footer class="main-footer"><div class="main-footer__top"><nav id="footer-1" class="main-footer__nav"><div class="navigation"><ul class="main-footer__nav-level1__items"><li class="main-footer__nav-level1__item"><a class="main-footer__nav__link -has-children" 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