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<feedburner:origLink>https://insights.citeline.com/medtech-insight/market-intelligence/data-trackers/global-medtech-guidance-tracker/global-medtech-guidance-tracker-october-2026-N2GNM6NY2NHWVHYXTBHSHPGXVU/</feedburner:origLink><title><![CDATA[Global Medtech Guidance Tracker: October 2026]]></title><contentRestrictions><![CDATA[<p>premium</p><Img align="left" border="0" height="1" width="1" alt="" style="border:0;float:left;margin:0;padding:0;width:1px!important;height:1px!important;" hspace="0" src="https://feeds.feedblitz.com/~/i/972517484/0/medtech">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/972517484/0/medtech~Global-Medtech-Guidance-Tracker-October/</link><guid isPermaLink="true">https://insights.citeline.com/medtech-insight/market-intelligence/data-trackers/global-medtech-guidance-tracker/global-medtech-guidance-tracker-october-2026-N2GNM6NY2NHWVHYXTBHSHPGXVU/</guid><dc:creator><![CDATA[Elizabeth Orr]]></dc:creator><description><![CDATA[Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. More than 40 documents have been posted on the tracker since its last update.<div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/vRhPSxP7wnNSxe415ggCaUvEOgs=/cloudfront-us-east-1.images.arcpublishing.com/norstella/AEL73BZH6FABHBP7324VRZLIIQ.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/vRhPSxP7wnNSxe415ggCaUvEOgs=/cloudfront-us-east-1.images.arcpublishing.com/norstella/AEL73BZH6FABHBP7324VRZLIIQ.jpg"/></a></div>
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</description><pubDate>Fri, 06 Nov 2026 21:06:58 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/vRhPSxP7wnNSxe415ggCaUvEOgs=/cloudfront-us-east-1.images.arcpublishing.com/norstella/AEL73BZH6FABHBP7324VRZLIIQ.jpg" type="image/jpeg" height="667" width="1000"/></item>
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<feedburner:origLink>https://insights.citeline.com/medtech-insight/business/investor-eye/bd-growth-platforms-lead-fourth-quarter-as-alaris-comparison-weighs-on-fiscal-2027-VFSBSRFTX5GMJAA52XEYFKTOCE/</feedburner:origLink><title><![CDATA[BD Growth Platforms Lead Fourth Quarter As Alaris Comparison Weighs On Fiscal 2027 ]]></title><contentRestrictions><![CDATA[<p>premium</p><Img align="left" border="0" height="1" width="1" alt="" style="border:0;float:left;margin:0;padding:0;width:1px!important;height:1px!important;" hspace="0" src="https://feeds.feedblitz.com/~/i/972513383/0/medtech">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/972513383/0/medtech~BD-Growth-Platforms-Lead-Fourth-Quarter-As-Alaris-Comparison-Weighs-On-Fiscal/</link><guid isPermaLink="true">https://insights.citeline.com/medtech-insight/business/investor-eye/bd-growth-platforms-lead-fourth-quarter-as-alaris-comparison-weighs-on-fiscal-2027-VFSBSRFTX5GMJAA52XEYFKTOCE/</guid><dc:creator><![CDATA[Brian Bossetta]]></dc:creator><description><![CDATA[BD’s fiscal fourth-quarter revenue rose 5.6% on a currency-neutral basis to $5.27bn, and adjusted EPS climbed 27.3% to $4.15. The CEO said growth platforms led the quarter and that mid-single-digit revenue growth should return as the Alaris comparison eases. <div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/HOkBaU3puoYanzSIn7goceDAwB8=/cloudfront-us-east-1.images.arcpublishing.com/norstella/OPN2U7NP3BAARLK6NQXU24ZGKI.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/HOkBaU3puoYanzSIn7goceDAwB8=/cloudfront-us-east-1.images.arcpublishing.com/norstella/OPN2U7NP3BAARLK6NQXU24ZGKI.jpg"/></a></div>
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</description><pubDate>Fri, 06 Nov 2026 19:53:38 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/HOkBaU3puoYanzSIn7goceDAwB8=/cloudfront-us-east-1.images.arcpublishing.com/norstella/OPN2U7NP3BAARLK6NQXU24ZGKI.jpg" type="image/jpeg" height="675" width="1200"/></item>
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<feedburner:origLink>https://insights.citeline.com/medtech-insight/policy-and-regulation/us-fda/device-makers-should-start-preparing-for-fda-genai-oversight-now-methodsense-ceo-says-OZNYUUL4B5DIDA7J5ORTFYLCNA/</feedburner:origLink><title><![CDATA[Device Makers Should Start Preparing For FDA GenAI Oversight Now, MethodSense CEO Says]]></title><contentRestrictions><![CDATA[<p>free</p><Img align="left" border="0" height="1" width="1" alt="" style="border:0;float:left;margin:0;padding:0;width:1px!important;height:1px!important;" hspace="0" src="https://feeds.feedblitz.com/~/i/972505634/0/medtech">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/972505634/0/medtech~Device-Makers-Should-Start-Preparing-For-FDA-GenAI-Oversight-Now-MethodSense-CEO-Says/</link><guid isPermaLink="true">https://insights.citeline.com/medtech-insight/policy-and-regulation/us-fda/device-makers-should-start-preparing-for-fda-genai-oversight-now-methodsense-ceo-says-OZNYUUL4B5DIDA7J5ORTFYLCNA/</guid><dc:creator><![CDATA[Elizabeth Orr]]></dc:creator><description><![CDATA[MethodSense CEO Rita King says device makers need not wait for FDA guidance on generative AI to prepare. She expects a focus on risk management, human-factors testing and postmarket monitoring, and urges early testing, cross-functional teams and presubmission meetings.<div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/ZN43cNd_s_xDGyoYHU3Yd0XGRr8=/cloudfront-us-east-1.images.arcpublishing.com/norstella/KV5ODHWVVZDP5BICEE4546VTQQ.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/ZN43cNd_s_xDGyoYHU3Yd0XGRr8=/cloudfront-us-east-1.images.arcpublishing.com/norstella/KV5ODHWVVZDP5BICEE4546VTQQ.jpg"/></a></div>
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</description><pubDate>Fri, 06 Nov 2026 17:39:33 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/ZN43cNd_s_xDGyoYHU3Yd0XGRr8=/cloudfront-us-east-1.images.arcpublishing.com/norstella/KV5ODHWVVZDP5BICEE4546VTQQ.jpg" type="image/jpeg" height="675" width="1200"><media:description type="plain"><![CDATA[The FDA's GenAI policy should incorporate risk management, human factors testing and postmarket monitoring, consultant Rita King said.]]></media:description><media:credit role="author" scheme="urn:ebu">Katawaredokii</media:credit></media:content></item>
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<feedburner:origLink>https://insights.citeline.com/medtech-insight/business/earnings/cardinal-health-raises-fy2027-guidance-despite-28-profit-drop-in-medical-products-segment-6FBPUVGKRFEWZK7HL42LK375ZA/</feedburner:origLink><title><![CDATA[Cardinal Health Raises FY2027 Guidance Despite 28% Profit Drop In Medical Products Segment]]></title><contentRestrictions><![CDATA[<p>premium</p><Img align="left" border="0" height="1" width="1" alt="" style="border:0;float:left;margin:0;padding:0;width:1px!important;height:1px!important;" hspace="0" src="https://feeds.feedblitz.com/~/i/972501332/0/medtech">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/972501332/0/medtech~Cardinal-Health-Raises-FY-Guidance-Despite-Profit-Drop-In-Medical-Products-Segment/</link><guid isPermaLink="true">https://insights.citeline.com/medtech-insight/business/earnings/cardinal-health-raises-fy2027-guidance-despite-28-profit-drop-in-medical-products-segment-6FBPUVGKRFEWZK7HL42LK375ZA/</guid><dc:creator><![CDATA[Elizabeth Orr]]></dc:creator><description><![CDATA[Cardinal Health raised its fiscal 2027 non-GAAP EPS guidance to $12.80–$13 after first-quarter non-GAAP EPS rose to $3.26, even as medical products segment profit fell 28%. It also signed a binding letter of intent to renew its CVS pharmacy agreements through 2032.<div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/ghj3MCY2VpgvLWB367_UmLz8A2o=/cloudfront-us-east-1.images.arcpublishing.com/norstella/2SCEPCSNPVFNJF3PKJE54A5LQ4.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/ghj3MCY2VpgvLWB367_UmLz8A2o=/cloudfront-us-east-1.images.arcpublishing.com/norstella/2SCEPCSNPVFNJF3PKJE54A5LQ4.jpg"/></a></div>
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</description><pubDate>Fri, 06 Nov 2026 16:33:58 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/ghj3MCY2VpgvLWB367_UmLz8A2o=/cloudfront-us-east-1.images.arcpublishing.com/norstella/2SCEPCSNPVFNJF3PKJE54A5LQ4.jpg" type="image/jpeg" height="675" width="1200"><media:description type="plain"><![CDATA[Cardinal Health's quarterly operating income soared to $1bn in the company's latest earnings report.]]></media:description><media:credit role="author" scheme="urn:ebu">Sari ONeal</media:credit></media:content></item>
<item>
<feedburner:origLink>https://insights.citeline.com/medtech-insight/business/earnings/solventum-counts-on-penetration-not-market-growth-to-power-growth-after-his-exit-YQB2PM72OJCYZPJZLTTVAWLW6Y/</feedburner:origLink><title><![CDATA[Solventum Counts On Penetration, Not Market Growth, To Power Growth After HIS Exit]]></title><contentRestrictions><![CDATA[<p>premium</p><Img align="left" border="0" height="1" width="1" alt="" style="border:0;float:left;margin:0;padding:0;width:1px!important;height:1px!important;" hspace="0" src="https://feeds.feedblitz.com/~/i/972480512/0/medtech">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/972480512/0/medtech~Solventum-Counts-On-Penetration-Not-Market-Growth-To-Power-Growth-After-HIS-Exit/</link><guid isPermaLink="true">https://insights.citeline.com/medtech-insight/business/earnings/solventum-counts-on-penetration-not-market-growth-to-power-growth-after-his-exit-YQB2PM72OJCYZPJZLTTVAWLW6Y/</guid><dc:creator><![CDATA[Phalguni  Deswal]]></dc:creator><description><![CDATA[Solventum raised 2026 EPS guidance and says the 3M separation is more than 90% complete after its biggest ERP cutover. Exiting HIS would dilute operating margin by about 400 basis points, and management is counting on penetration, not market growth, to power the remaining company.<div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/i5eMygiEU5yOIs7ZukPh6BsD8As=/cloudfront-us-east-1.images.arcpublishing.com/norstella/PQGMXUPGSFGMTH53CVZTEMP2VE.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/i5eMygiEU5yOIs7ZukPh6BsD8As=/cloudfront-us-east-1.images.arcpublishing.com/norstella/PQGMXUPGSFGMTH53CVZTEMP2VE.jpg"/></a></div>
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</description><pubDate>Fri, 06 Nov 2026 12:26:58 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/i5eMygiEU5yOIs7ZukPh6BsD8As=/cloudfront-us-east-1.images.arcpublishing.com/norstella/PQGMXUPGSFGMTH53CVZTEMP2VE.jpg" type="image/jpeg" height="564" width="1000"><media:description type="plain"><![CDATA[Solventum said its separation from 3M is more than 90% complete]]></media:description></media:content></item>
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<feedburner:origLink>https://insights.citeline.com/medtech-insight/business/deals/reimbursement-before-approval-blue-arbors-strategy-to-avoid-a-common-device-trap-35ZNYLA6HJB37E2PAVS3AVBBBA/</feedburner:origLink><title><![CDATA[Reimbursement Before Approval: Blue Arbor’s Strategy To Avoid A Common Device Trap]]></title><contentRestrictions><![CDATA[<p>premium</p><Img align="left" border="0" height="1" width="1" alt="" style="border:0;float:left;margin:0;padding:0;width:1px!important;height:1px!important;" hspace="0" src="https://feeds.feedblitz.com/~/i/972483566/0/medtech">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/972483566/0/medtech~Reimbursement-Before-Approval-Blue-Arbor%e2%80%99s-Strategy-To-Avoid-A-Common-Device-Trap/</link><guid isPermaLink="true">https://insights.citeline.com/medtech-insight/business/deals/reimbursement-before-approval-blue-arbors-strategy-to-avoid-a-common-device-trap-35ZNYLA6HJB37E2PAVS3AVBBBA/</guid><dc:creator><![CDATA[Shubham Singh]]></dc:creator><description><![CDATA[Blue Arbor Technologies has closed a $10.5m Series A round led by Ottobock.  The four-person company is using an FDA pilot to shape its trials around data for future billing codes and will sell only the fully implantable version of its RESTORE nerve interface.<div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/iiUatI80CPO0dBI0Al5RtbPfWXw=/cloudfront-us-east-1.images.arcpublishing.com/norstella/UBQFVIE4MNEQPFMQWRNNR77DCM.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/iiUatI80CPO0dBI0Al5RtbPfWXw=/cloudfront-us-east-1.images.arcpublishing.com/norstella/UBQFVIE4MNEQPFMQWRNNR77DCM.jpg"/></a></div>
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</description><pubDate>Fri, 06 Nov 2026 13:18:09 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/iiUatI80CPO0dBI0Al5RtbPfWXw=/cloudfront-us-east-1.images.arcpublishing.com/norstella/UBQFVIE4MNEQPFMQWRNNR77DCM.jpg" type="image/jpeg" height="675" width="1200"><media:description type="plain"><![CDATA[The company said the funds will be used to complete feasibility studies and to pursue an FDA investigational device exemption to support US clinical studies of the RESTORE external sensing unit (ESU). Picture Courtesy: Blue Arbor]]></media:description></media:content></item>
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<feedburner:origLink>https://insights.citeline.com/medtech-insight/business/earnings/siemens-healthineers-announces-name-change-as-spin-off-looms-UCW6A2KNZJBNLKLPMTC6XLLBOM/</feedburner:origLink><title><![CDATA[Siemens Healthineers Announces Name Change As Spin-off Looms]]></title><contentRestrictions><![CDATA[<p>premium</p><Img align="left" border="0" height="1" width="1" alt="" style="border:0;float:left;margin:0;padding:0;width:1px!important;height:1px!important;" hspace="0" src="https://feeds.feedblitz.com/~/i/972462737/0/medtech">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/972462737/0/medtech~Siemens-Healthineers-Announces-Name-Change-As-Spinoff-Looms/</link><guid isPermaLink="true">https://insights.citeline.com/medtech-insight/business/earnings/siemens-healthineers-announces-name-change-as-spin-off-looms-UCW6A2KNZJBNLKLPMTC6XLLBOM/</guid><dc:creator><![CDATA[George Underwood]]></dc:creator><description><![CDATA[Diagnostics carve-out also gets a new name and predicted completion date of mid-2028 as company announces fiscal year 2026 results. <div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/-_9MeXa_BCs2JGXepZ8JlRQYtnM=/cloudfront-us-east-1.images.arcpublishing.com/norstella/U6EYYN3QXVGUJEDFK3IZ3UB4EU.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/-_9MeXa_BCs2JGXepZ8JlRQYtnM=/cloudfront-us-east-1.images.arcpublishing.com/norstella/U6EYYN3QXVGUJEDFK3IZ3UB4EU.jpg"/></a></div>
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</description><pubDate>Fri, 06 Nov 2026 08:23:48 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/-_9MeXa_BCs2JGXepZ8JlRQYtnM=/cloudfront-us-east-1.images.arcpublishing.com/norstella/U6EYYN3QXVGUJEDFK3IZ3UB4EU.jpg" type="image/jpeg" height="1081" width="1920"><media:description type="plain"><![CDATA[CEO Bernd Montag reveals Healthineers as his company's new name at a FY results press conference]]></media:description></media:content></item>
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<feedburner:origLink>https://insights.citeline.com/medtech-insight/business/earnings/edwards-raises-guidance-as-tmtt-sales-grow-over-40-ahead-of-pascal-tricuspid-approval-UWB7I3NXNFANRGZWSL3DA5Q64M/</feedburner:origLink><title><![CDATA[Edwards Raises Guidance As TMTT Sales Grow Over 40% Ahead Of PASCAL Tricuspid Approval]]></title><contentRestrictions><![CDATA[<p>premium</p><Img align="left" border="0" height="1" width="1" alt="" style="border:0;float:left;margin:0;padding:0;width:1px!important;height:1px!important;" hspace="0" src="https://feeds.feedblitz.com/~/i/972442763/0/medtech">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/972442763/0/medtech~Edwards-Raises-Guidance-As-TMTT-Sales-Grow-Over-Ahead-Of-PASCAL-Tricuspid-Approval/</link><guid isPermaLink="true">https://insights.citeline.com/medtech-insight/business/earnings/edwards-raises-guidance-as-tmtt-sales-grow-over-40-ahead-of-pascal-tricuspid-approval-UWB7I3NXNFANRGZWSL3DA5Q64M/</guid><dc:creator><![CDATA[Elizabeth Orr]]></dc:creator><description><![CDATA[Edwards Lifesciences reported 11.2% constant currency sales growth for the third quarter of 2026, bringing sales for the quarter to $1.72bn. TAVR grew 8.8%, while TMTT grew 45.6%. The company raised its 2026 sales and adjusted EPS guidance.<div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/nB4wmVvglFUeqgVsHPCW67op49I=/cloudfront-us-east-1.images.arcpublishing.com/norstella/V7TCYIJXJRBBJOJT4X5RE4LJJI.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/nB4wmVvglFUeqgVsHPCW67op49I=/cloudfront-us-east-1.images.arcpublishing.com/norstella/V7TCYIJXJRBBJOJT4X5RE4LJJI.jpg"/></a></div>
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</description><pubDate>Thu, 05 Nov 2026 23:22:28 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/nB4wmVvglFUeqgVsHPCW67op49I=/cloudfront-us-east-1.images.arcpublishing.com/norstella/V7TCYIJXJRBBJOJT4X5RE4LJJI.jpg" type="image/jpeg" height="522" width="1000"><media:description type="plain"><![CDATA[Edwards raised its 2026 sales, TAVR, TMTT and adjusted EPS guidance in a Nov. 4 3Q 2026 earnings report.]]></media:description></media:content></item>
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<feedburner:origLink>https://insights.citeline.com/medtech-insight/policy-and-regulation/us-fda/another-midterm-wave-coming-us-fda-chief-counsel-announces-departure-XVTD5Z6FAREO3EABZGBJZ75TQE/</feedburner:origLink><title><![CDATA[Another Midterm Wave Coming? US FDA Chief Counsel Announces Departure]]></title><contentRestrictions><![CDATA[<p>premium</p><Img align="left" border="0" height="1" width="1" alt="" style="border:0;float:left;margin:0;padding:0;width:1px!important;height:1px!important;" hspace="0" src="https://feeds.feedblitz.com/~/i/972442760/0/medtech">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/972442760/0/medtech~Another-Midterm-Wave-Coming-US-FDA-Chief-Counsel-Announces-Departure/</link><guid isPermaLink="true">https://insights.citeline.com/medtech-insight/policy-and-regulation/us-fda/another-midterm-wave-coming-us-fda-chief-counsel-announces-departure-XVTD5Z6FAREO3EABZGBJZ75TQE/</guid><dc:creator><![CDATA[Derrick Gingery]]></dc:creator><description><![CDATA[Sean Keveney agreed to stay in the job until a successor is found and a transition is completed, but he could be one of several political appointees to leave the agency.<div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/nA6pwuIgG6rCB6QP8OAzMziLxTY=/cloudfront-us-east-1.images.arcpublishing.com/norstella/LDBAB5WAOJBUDLGSFJN6KS5CNY.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/nA6pwuIgG6rCB6QP8OAzMziLxTY=/cloudfront-us-east-1.images.arcpublishing.com/norstella/LDBAB5WAOJBUDLGSFJN6KS5CNY.jpg"/></a></div>
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</description><pubDate>Thu, 05 Nov 2026 23:31:52 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/nA6pwuIgG6rCB6QP8OAzMziLxTY=/cloudfront-us-east-1.images.arcpublishing.com/norstella/LDBAB5WAOJBUDLGSFJN6KS5CNY.jpg" type="image/jpeg" height="675" width="1200"><media:description type="plain"><![CDATA[The “blue wave” saw big gains for Democrats in the US midterms.]]></media:description></media:content></item>
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