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BioWorld MedTech Perspectives
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Saturday, November 23, 2024</div></section><div id="section-2" class="main-body page-blogs-show"> <div id="breadcrumbs" class="breadcrumbs"><a class="" href="/">Home</a> » <a class="" href="https://www.bioworld.com/blogs">Blogs</a> » BioWorld MedTech Perspectives</div> <div class="box1 blog"> <div class="records"> <section class="blog-header"> <h1 class="page-title blog-header__title"> BioWorld MedTech Perspectives <div class="rss"> <a href="/rss/blog/2-bioworld-medtech-perspectives"> <img alt="BioWorld MedTech Perspectives RSS Feed" height="16" width="16" loading="lazy" src="/images/icons/rss.gif" />RSS</a> </a> </div> </h1> <div class="abstract blog-header__teaser"></div> </section> <div class="sidebar"> </div> <section class="blog-articles-list"> <article class="record article-summary "> <div class="image"><a title="Goldilocks or bust: The FDA’s regulatory harmonization dilemma" class="url" rel="" target="" href="https://www.bioworld.com/blogs/2-bioworld-medtech-perspectives/post/515748-goldilocks-or-bust-the-fdas-regulatory-harmonization-dilemma"><img width="650" height="488" alt="ISO icons" title="ISO icons" border="0" loading="lazy" src="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/international-standards-ISO.png?height=488&t=1623704519&width=650" /></a></div> <div class="article-summary__details has-image"> <h2 class="headline article-summary__headline"><a href="https://www.bioworld.com/blogs/2-bioworld-medtech-perspectives/post/515748-goldilocks-or-bust-the-fdas-regulatory-harmonization-dilemma">Goldilocks or bust: The FDA’s regulatory harmonization dilemma</a></h2> <div class="post-meta"> <div class="date article-summary__post-date">Feb. 3, 2022</div> <div class="author article-summary__author">By <a href="/authors/21-mark-mccarty">Mark McCarty</a></div> <div class="comment-count article-summary__comment-count"><a title="Goldilocks or bust: The FDA’s regulatory harmonization dilemma" class="more" href="https://www.bioworld.com/blogs/2-bioworld-medtech-perspectives/post/515748-goldilocks-or-bust-the-fdas-regulatory-harmonization-dilemma#comments-container">No Comments</a></div> </div> <div class="abstract article-summary__teaser"><p>We’ve been hearing for several years about an FDA proposal to overhaul its device regulatory framework with ISO 13485, potentially the most ambitious FDA undertaking in a quarter century. Those who don’t follow these things might find the subject terminally boring, but such a change could be a massive headache for industry, although it doesn’t have to be if the FDA can get the temperature of this regulatory porridge just right.</p><br /></div><a title="Goldilocks or bust: The FDA’s regulatory harmonization dilemma" class="more" href="https://www.bioworld.com/blogs/2-bioworld-medtech-perspectives/post/515748-goldilocks-or-bust-the-fdas-regulatory-harmonization-dilemma">Read More</a> </div> </article> <article class="record article-summary "> <div class="image"><a title="Forward to the past: The FDA commissioner dilemma" class="url" rel="" target="" href="https://www.bioworld.com/blogs/2-bioworld-medtech-perspectives/post/510419-forward-to-the-past-the-fda-commissioner-dilemma"><img width="650" height="488" alt="Magnifying glass, FDA concept image" title="Magnifying glass, FDA concept image" border="0" loading="lazy" src="https://www.bioworld.com/ext/resources/BMT-source/2021/08-13-Blog-FDA.png?height=488&t=1628871192&width=650" /></a></div> <div class="article-summary__details has-image"> <h2 class="headline article-summary__headline"><a href="https://www.bioworld.com/blogs/2-bioworld-medtech-perspectives/post/510419-forward-to-the-past-the-fda-commissioner-dilemma">Forward to the past: The FDA commissioner dilemma</a></h2> <div class="post-meta"> <div class="date article-summary__post-date">Aug. 13, 2021</div> <div class="author article-summary__author">By <a href="/authors/21-mark-mccarty">Mark McCarty</a></div> </div> <div class="abstract article-summary__teaser">As we’ve all undoubtedly noticed, the FDA commissioner’s chair is conspicuously absent a duly deputized occupant, and a number of reasons have been offered to explain that. Some of these, such as the COVID-19 pandemic, will eventually give way, but some of the drag is unrelated to temporary issues, which is the more worrisome part of the problem.<br /></div><a title="Forward to the past: The FDA commissioner dilemma" class="more" href="https://www.bioworld.com/blogs/2-bioworld-medtech-perspectives/post/510419-forward-to-the-past-the-fda-commissioner-dilemma">Read More</a> </div> </article> <article class="record article-summary "> <div class="image"><a title="U.S. politicking threatens public trust in the FDA and CDC" class="url" rel="" target="" href="https://www.bioworld.com/blogs/2-bioworld-medtech-perspectives/post/497103-us-politicking-threatens-public-trust-in-the-fda-and-cdc"><img width="650" height="488" alt="Health care and politics illustration" title="Health care and politics illustration" border="0" loading="lazy" src="https://www.bioworld.com/ext/resources/Stock-images/Misc/Health-care-politics-illustration.png?height=488&t=1598472218&width=650" /></a></div> <div class="article-summary__details has-image"> <h2 class="headline article-summary__headline"><a href="https://www.bioworld.com/blogs/2-bioworld-medtech-perspectives/post/497103-us-politicking-threatens-public-trust-in-the-fda-and-cdc">U.S. politicking threatens public trust in the FDA and CDC</a></h2> <div class="post-meta"> <div class="date article-summary__post-date">Aug. 26, 2020</div> <div class="author article-summary__author">By <a href="/authors/4-mari-serebrov">Mari Serebrov</a></div> </div> <div class="abstract article-summary__teaser">The truth that every action has a reaction is being proven again in the public square of the U.S. as the shrill, endless clamor of politicians hoping to score against their opponents via health care issues or accomplishments threatens to undermine confidence in the FDA, the products it approves and even the guidance offered by the Centers for Disease Control and Protection (CDC). In the past, politicians from both parties blamed “greedy” biopharma companies and self-appointed social influencers for patients refusing to fill prescriptions, get tested or be immunized. Now they have themselves to blame.<br /></div><a title="U.S. politicking threatens public trust in the FDA and CDC" class="more" href="https://www.bioworld.com/blogs/2-bioworld-medtech-perspectives/post/497103-us-politicking-threatens-public-trust-in-the-fda-and-cdc">Read More</a> </div> </article> <article class="record article-summary "> <div class="image"><a title="The demise of the device tax and other fun med-tech stories" class="url" rel="" target="" href="https://www.bioworld.com/blogs/2-bioworld-medtech-perspectives/post/432211-the-demise-of-the-device-tax-and-other-fun-med-tech-stories"><img width="650" height="488" alt="Speech bubbles" title="Speech bubbles" border="0" loading="lazy" src="https://www.bioworld.com/ext/resources/Stock-images/Misc/Speech-bubble-pic.png?height=488&t=1588286276&width=650" /></a></div> <div class="article-summary__details has-image"> <h2 class="headline article-summary__headline"><a href="https://www.bioworld.com/blogs/2-bioworld-medtech-perspectives/post/432211-the-demise-of-the-device-tax-and-other-fun-med-tech-stories">The demise of the device tax and other fun med-tech stories</a></h2> <div class="post-meta"> <div class="date article-summary__post-date">Jan. 7, 2020</div> <div class="author article-summary__author">By <a href="/authors/21-mark-mccarty">Mark McCarty</a></div> </div> <div class="abstract article-summary__teaser">It’s mighty tempting to run a little play on words with regard to eyesight in this new year, but I need reading glasses, so far be it from me to pepper a blog with wisecracks about 20-20 vision in 2020. Still, there are a few things to look forward to in this new year, including some great expectations and one or two desperate hopes.<br /></div><a title="The demise of the device tax and other fun med-tech stories" class="more" href="https://www.bioworld.com/blogs/2-bioworld-medtech-perspectives/post/432211-the-demise-of-the-device-tax-and-other-fun-med-tech-stories">Read More</a> </div> </article> <article class="record article-summary "> <div class="image"><a title="Missed Opportunity: The epidemic of poor sleep" class="url" rel="" target="" href="https://www.bioworld.com/blogs/2-bioworld-medtech-perspectives/post/430562-missed-opportunity-the-epidemic-of-poor-sleep"><img width="560" height="392" alt="awake in bed illustration" title="1900_The_Awakening70.jpg" border="0" loading="lazy" src="https://www.bioworld.com/ext/resources/wp-content/blogs.dir/16/files/2019/1900_The_Awakening70.jpg?height=488&t=1572386982&width=650" /></a></div> <div class="article-summary__details has-image"> <h2 class="headline article-summary__headline"><a href="https://www.bioworld.com/blogs/2-bioworld-medtech-perspectives/post/430562-missed-opportunity-the-epidemic-of-poor-sleep">Missed Opportunity: The epidemic of poor sleep</a></h2> <div class="post-meta"> <div class="date article-summary__post-date">Sep. 19, 2019</div> <div class="author article-summary__author">By <a href="/authors/21-mark-mccarty">Mark McCarty</a></div> </div> <div class="abstract article-summary__teaser">There are a lot of ways to save money without going bankrupt in the process, but health care in the U.S. certainly has not lent itself to that sort of thing. Still, there’s a big opportunity to do just that if one demonstrates an interest in sleep, a subject about which there is little evident interest in Washington, D.C., or in the boardrooms of med tech firms. According to a study by the Rand Corporation, data from five OECD nations suggest that those who sleep...<br /></div><a title="Missed Opportunity: The epidemic of poor sleep" class="more" href="https://www.bioworld.com/blogs/2-bioworld-medtech-perspectives/post/430562-missed-opportunity-the-epidemic-of-poor-sleep">Read More</a> </div> </article> <article class="record article-summary "> <div class="article-summary__details "> <h2 class="headline article-summary__headline"><a href="https://www.bioworld.com/blogs/2-bioworld-medtech-perspectives/post/430561-next-up-for-tavr-bicuspid-valve">Next up for TAVR: bicuspid valve</a></h2> <div class="post-meta"> <div class="date article-summary__post-date">Aug. 27, 2019</div> <div class="author article-summary__author">By <a href="/authors/21-mark-mccarty">Mark McCarty</a></div> </div> <div class="abstract article-summary__teaser">Now that the existing inventory of FDA-approved transcatheter aortic valve replacement (TAVR) devices has received a green light for patients at low surgical risk, it’s tempting to think this device type has pretty much conquered all that lay before it. That’s not the case, however, as the question of bicuspid valve might be answered in a way that gives Edwards Lifesciences and Medtronic another sizeable patient population for their TAVR offerings. As is widely known, the FDA recently approved two TAVR devices each by Medtronic...<br /></div><a title="Next up for TAVR: bicuspid valve" class="more" href="https://www.bioworld.com/blogs/2-bioworld-medtech-perspectives/post/430561-next-up-for-tavr-bicuspid-valve">Read More</a> </div> </article> <article class="record article-summary "> <div class="image"><a title="Cabanas and commissioners; med tech in the news" class="url" rel="" target="" href="https://www.bioworld.com/blogs/2-bioworld-medtech-perspectives/post/430560-cabanas-and-commissioners-med-tech-in-the-news"><img width="448" height="301" alt="cabana hut" title="Cabana35.jpg" border="0" loading="lazy" src="https://www.bioworld.com/ext/resources/wp-content/blogs.dir/16/files/2019/Cabana35.jpg?height=488&t=1572385972&width=650" /></a></div> <div class="article-summary__details has-image"> <h2 class="headline article-summary__headline"><a href="https://www.bioworld.com/blogs/2-bioworld-medtech-perspectives/post/430560-cabanas-and-commissioners-med-tech-in-the-news">Cabanas and commissioners; med tech in the news</a></h2> <div class="post-meta"> <div class="date article-summary__post-date">May 30, 2019</div> <div class="author article-summary__author">By <a href="/authors/21-mark-mccarty">Mark McCarty</a></div> </div> <div class="abstract article-summary__teaser">We who write about medical devices rarely suffer for content, but the month of May was unusually cooperative even by our standards. Following are two stories about medical devices that either emerged or resurfaced in the merry month of May, each of which involves a cardiologist and what some of us now think of as not-so-social media. Cabana and the case for catheter ablation We’ve all heard at least a little of the noise about catheter ablation for atrial fibrillation over the years, including assertions...<br /></div><a title="Cabanas and commissioners; med tech in the news" class="more" href="https://www.bioworld.com/blogs/2-bioworld-medtech-perspectives/post/430560-cabanas-and-commissioners-med-tech-in-the-news">Read More</a> </div> </article> <article class="record article-summary "> <div class="image"><a title="FDA’s new man of regulatory mystery" class="url" rel="" target="" href="https://www.bioworld.com/blogs/2-bioworld-medtech-perspectives/post/430559-fdas-new-man-of-regulatory-mystery"><img width="338" height="338" alt="sharpless headshot" title="sharpless50x75.jpg" border="0" loading="lazy" src="https://www.bioworld.com/ext/resources/wp-content/blogs.dir/16/files/2019/sharpless50x75.jpg?height=488&t=1572386554&width=650" /></a></div> <div class="article-summary__details has-image"> <h2 class="headline article-summary__headline"><a href="https://www.bioworld.com/blogs/2-bioworld-medtech-perspectives/post/430559-fdas-new-man-of-regulatory-mystery">FDA’s new man of regulatory mystery</a></h2> <div class="post-meta"> <div class="date article-summary__post-date">April 30, 2019</div> <div class="author article-summary__author">By <a href="/authors/21-mark-mccarty">Mark McCarty</a></div> </div> <div class="abstract article-summary__teaser">Life has a lot of unknowns, and one of the big unknowns for 2019 is what the FDA will look like now that Scott Gottlieb has returned to the American Enterprise Institute. Norm Sharpless of the National Cancer Institute has been named the acting FDA commissioner – which by itself doesn’t mean a whole lot, other than that he has to be considered a lead candidate for the job – but the difficulty in knowing where the agency would go in terms of policy under...<br /></div><a title="FDA’s new man of regulatory mystery" class="more" href="https://www.bioworld.com/blogs/2-bioworld-medtech-perspectives/post/430559-fdas-new-man-of-regulatory-mystery">Read More</a> </div> </article> <article class="record article-summary "> <div class="image"><a title="Scott Gottlieb and the FDA’s revolving door problem" class="url" rel="" target="" href="https://www.bioworld.com/blogs/2-bioworld-medtech-perspectives/post/430558-scott-gottlieb-and-the-fdas-revolving-door-problem"><img width="320" height="240" alt="revolving door sign" title="RevolvingSmall.jpg" border="0" loading="lazy" src="https://www.bioworld.com/ext/resources/wp-content/blogs.dir/16/files/2019/RevolvingSmall.jpg?height=488&t=1572385703&width=650" /></a></div> <div class="article-summary__details has-image"> <h2 class="headline article-summary__headline"><a href="https://www.bioworld.com/blogs/2-bioworld-medtech-perspectives/post/430558-scott-gottlieb-and-the-fdas-revolving-door-problem">Scott Gottlieb and the FDA’s revolving door problem</a></h2> <div class="post-meta"> <div class="date article-summary__post-date">March 7, 2019</div> <div class="author article-summary__author">By <a href="/authors/21-mark-mccarty">Mark McCarty</a></div> </div> <div class="abstract article-summary__teaser">Now that the dust is still swirling over the news that Scott Gottlieb will leave the FDA, it’s time to conduct a hasty post-mortem on his tenure at the agency, or perhaps more to the point, his lack of tenure. While it’s tempting to frame the question that way, it might be more salient to ask about the nature of the FDA commissioner’s job and whether it is still sufficiently politically insulated to do what is asked of it. Gottlieb had been on the job...<br /></div><a title="Scott Gottlieb and the FDA’s revolving door problem" class="more" href="https://www.bioworld.com/blogs/2-bioworld-medtech-perspectives/post/430558-scott-gottlieb-and-the-fdas-revolving-door-problem">Read More</a> </div> </article> <article class="record article-summary "> <div class="image"><a title="Four “Spooky” ways to fix the 510(k) dilemma" class="url" rel="" target="" href="https://www.bioworld.com/blogs/2-bioworld-medtech-perspectives/post/748-four-spooky-ways-to-fix-the-510-k-dilemma"><img width="341" height="488" title="510K" border="0" loading="lazy" src="https://www.bioworld.com/ext/resources/wp-content/blogs.dir/16/files/2018/12/510K.gif?height=488&t=1556314384&width=650" /></a></div> <div class="article-summary__details has-image"> <h2 class="headline article-summary__headline"><a href="https://www.bioworld.com/blogs/2-bioworld-medtech-perspectives/post/748-four-spooky-ways-to-fix-the-510-k-dilemma">Four “Spooky” ways to fix the 510(k) dilemma</a></h2> <div class="post-meta"> <div class="date article-summary__post-date">Dec. 13, 2018</div> <div class="author article-summary__author">By <a href="/authors/21-mark-mccarty">Mark McCarty</a></div> <div class="comment-count article-summary__comment-count"><a title="Four “Spooky” ways to fix the 510(k) dilemma" class="more" href="https://www.bioworld.com/blogs/2-bioworld-medtech-perspectives/post/748-four-spooky-ways-to-fix-the-510-k-dilemma#comments-container">No Comments</a></div> </div> <div class="abstract article-summary__teaser">A now-little known band called the Classics IV made a big splash in 1968 when their Hallowe’en love song “Spooky” charted at #3 on the U.S. Billboard Hot 100, and eerie though it may sound, there might be a lesson in there for the FDA half a century later. Sound preposterous? Read on and decide for yourself. House (and Senate) on Haunted Hill As we’ve all seen, the FDA has proposed to pull the substantial equivalence standard for 510(k) filings, but the agency also acknowledged that these 510(k) submissions have ballooned over the past decade or so. Some of that...<br /></div><a title="Four “Spooky” ways to fix the 510(k) dilemma" class="more" href="https://www.bioworld.com/blogs/2-bioworld-medtech-perspectives/post/748-four-spooky-ways-to-fix-the-510-k-dilemma">Read More</a> </div> </article> </section> </div> <div class="pager"> <div role="navigation" aria-label="Pagination" class="pagination"><span class="previous_page disabled" aria-disabled="true">Previous</span> <em class="current" aria-label="Page 1" aria-current="page">1</em> <a rel="next" aria-label="Page 2" href="/blogs/2-bioworld-medtech-perspectives?page=2">2</a> <a aria-label="Page 3" href="/blogs/2-bioworld-medtech-perspectives?page=3">3</a> <a aria-label="Page 4" href="/blogs/2-bioworld-medtech-perspectives?page=4">4</a> <a aria-label="Page 5" href="/blogs/2-bioworld-medtech-perspectives?page=5">5</a> <a aria-label="Page 6" href="/blogs/2-bioworld-medtech-perspectives?page=6">6</a> <a aria-label="Page 7" href="/blogs/2-bioworld-medtech-perspectives?page=7">7</a> <a aria-label="Page 8" href="/blogs/2-bioworld-medtech-perspectives?page=8">8</a> <a aria-label="Page 9" href="/blogs/2-bioworld-medtech-perspectives?page=9">9</a> <span class="gap">…</span> <a aria-label="Page 50" href="/blogs/2-bioworld-medtech-perspectives?page=50">50</a> <a aria-label="Page 51" href="/blogs/2-bioworld-medtech-perspectives?page=51">51</a> <a class="next_page" rel="next" href="/blogs/2-bioworld-medtech-perspectives?page=2">Next</a></div> </div> </div> </div> <aside class="main-interior-sidebar"><div class="main-interior-sidebar__column"><div id="article-recommendations"></div> </div><div class="main-interior-sidebar__column"><section class="popular-stories "> <h1 class="popular-stories__title">Popular Stories</h1><ul class="popular-stories__items"> <li class="popular-stories__item"> <article class="popular-stories__article popular-stories--article"><div class="popular-stories__details popular-stories__details-1"><h1 class="popular-stories__headline"><a class="popular-stories__article-title-link" href="https://www.bioworld.com/articles/432891-todays-news-in-brief">Today's news in brief</a></h1><div class="popular-stories__topics"><a class="popular-stories__topic-link" href="/topics/84-bioworld">BioWorld</a></div><div class="popular-stories__teaser"><em>BioWorld</em> briefs for Nov. 22, 2024.</div></div></article> </li> <li class="popular-stories__item"> <article class="popular-stories__article popular-stories--article"><div class="popular-stories__details popular-stories__details-1"><h1 class="popular-stories__headline"><a class="popular-stories__article-title-link" href="https://www.bioworld.com/articles/699574-todays-news-in-brief">Today's news in brief</a></h1><div class="popular-stories__topics"><a class="popular-stories__topic-link" href="/topics/85-bioworld-medtech">BioWorld MedTech</a></div><div class="popular-stories__teaser"><em>BioWorld MedTech</em> briefs for November 21, 2024.</div></div></article> </li> <li class="popular-stories__item"> <article class="popular-stories__article -has-image popular-stories--article"><figure class="popular-stories__image"><a class="popular-stories__thumbnail-link" data-eventname="popular-stories" data-eventcategory="click" data-eventaction="popular-stories-image" data-eventlabel="https://www.bioworld.com/articles/714048-j-and-js-ottava-robotic-system-approved-for-us-pivotal-trial" href="https://www.bioworld.com/articles/714048-j-and-js-ottava-robotic-system-approved-for-us-pivotal-trial"><img class="popular-stories__image-thumb" alt="Da Vinci Xi robot - Intuitive Surgical" title="Da Vinci Xi robot - Intuitive Surgical" width="640" height="355" loading="lazy" src="https://www.bioworld.com/ext/resources/BMT-source/2023/1-26--Da-Vinci-Xi-robot-Intuitive-Surgical.png?height=355&t=1699482891&width=640" /></a></figure><div class="popular-stories__details popular-stories__details-1"><h1 class="popular-stories__headline"><a class="popular-stories__article-title-link" href="https://www.bioworld.com/articles/714048-j-and-js-ottava-robotic-system-approved-for-us-pivotal-trial">J&J’s Ottava robotic system approved for US pivotal trial</a></h1><div class="popular-stories__topics"><a class="popular-stories__topic-link" href="/topics/85-bioworld-medtech">BioWorld MedTech</a></div><div class="popular-stories__teaser">Johnson & Johnson received U.S. FDA investigational device exemption to begin the pivotal clinical trial for the Ottava robotic surgical system. 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