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<feedburner:origLink>https://insights.citeline.com/medtech-insight/device-area/diagnostics/flow-neuroscience-launches-at-home-fda-approved-brain-stimulation-device-for-depression-in-us-KOJN43L2DZCBHIECOBUKNPVT2E/</feedburner:origLink><title><![CDATA[Flow Neuroscience Launches At-Home, FDA-Approved Brain Stimulation Device For Depression In US]]></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/968989703/0/medtech">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/968989703/0/medtech~Flow-Neuroscience-Launches-AtHome-FDAApproved-Brain-Stimulation-Device-For-Depression-In-US/</link><guid isPermaLink="true">https://insights.citeline.com/medtech-insight/device-area/diagnostics/flow-neuroscience-launches-at-home-fda-approved-brain-stimulation-device-for-depression-in-us-KOJN43L2DZCBHIECOBUKNPVT2E/</guid><dc:creator><![CDATA[Marion Webb]]></dc:creator><description><![CDATA[Flow Neuroscience launched its FDA-approved at-home tDCS device FL-100 in the US this week at a patient cost of $2,200 for an initial 10-week course and $325 for every additional four weeks of treatment. <div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/r2fC4tcc4vpP8axxU53AX_z0PSY=/cloudfront-us-east-1.images.arcpublishing.com/norstella/KVK3FG3CAFBNDNW5RJNCFC3HD4.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/r2fC4tcc4vpP8axxU53AX_z0PSY=/cloudfront-us-east-1.images.arcpublishing.com/norstella/KVK3FG3CAFBNDNW5RJNCFC3HD4.jpg"/></a></div>
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</description><pubDate>Fri, 11 Sep 2026 22:33:44 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/r2fC4tcc4vpP8axxU53AX_z0PSY=/cloudfront-us-east-1.images.arcpublishing.com/norstella/KVK3FG3CAFBNDNW5RJNCFC3HD4.jpg" type="image/jpeg" height="4380" width="6570"><media:description type="plain"><![CDATA[This week, neurotech company Flow Neuroscience will introduce its prescription-based, home-use brain stimulation device for treating depression in the United States.]]></media:description></media:content></item>
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<feedburner:origLink>https://insights.citeline.com/medtech-insight/policy-and-regulation/us-fda/cdrh-moves-to-close-rare-disease-device-gap-with-new-initiative-and-device-list-WGRSKWKBJRHETGBAJU6NVIHH2M/</feedburner:origLink><title><![CDATA[CDRH Moves To Close Rare Disease Device Gap With New Initiative And Device List ]]></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/968985767/0/medtech">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/968985767/0/medtech~CDRH-Moves-To-Close-Rare-Disease-Device-Gap-With-New-Initiative-And-Device-List/</link><guid isPermaLink="true">https://insights.citeline.com/medtech-insight/policy-and-regulation/us-fda/cdrh-moves-to-close-rare-disease-device-gap-with-new-initiative-and-device-list-WGRSKWKBJRHETGBAJU6NVIHH2M/</guid><dc:creator><![CDATA[Brian Bossetta]]></dc:creator><description><![CDATA[CDRH’s Rare Disease Impact Initiative seeks to advance the development and authorization of devices to treat rare diseases. The effort aims to address development challenges, identify unmet device needs, strengthen collaboration, and provide resources including a Rare Disease Medical Device List.<div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/pP_w49__KiUCJiBQRs9OSyo4y3I=/cloudfront-us-east-1.images.arcpublishing.com/norstella/2NHUL2QSSFAKTM5F3P75ZTKMCA.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/pP_w49__KiUCJiBQRs9OSyo4y3I=/cloudfront-us-east-1.images.arcpublishing.com/norstella/2NHUL2QSSFAKTM5F3P75ZTKMCA.jpg"/></a></div>
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</description><pubDate>Fri, 11 Sep 2026 20:07:26 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/pP_w49__KiUCJiBQRs9OSyo4y3I=/cloudfront-us-east-1.images.arcpublishing.com/norstella/2NHUL2QSSFAKTM5F3P75ZTKMCA.jpg" type="image/jpeg" height="675" width="1200"/></item>
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<feedburner:origLink>https://insights.citeline.com/medtech-insight/policy-and-regulation/approvals/fda-approval-in-hand-implantica-prepares-to-launch-mechanical-gerd-fix-in-us-IEEZJR7UTBCAVBLTCJ3ZR27ZDU/</feedburner:origLink><title><![CDATA[FDA Approval In Hand, Implantica Prepares To Launch Mechanical GERD Fix In US ]]></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/968983448/0/medtech">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/968983448/0/medtech~FDA-Approval-In-Hand-Implantica-Prepares-To-Launch-Mechanical-GERD-Fix-In-US/</link><guid isPermaLink="true">https://insights.citeline.com/medtech-insight/policy-and-regulation/approvals/fda-approval-in-hand-implantica-prepares-to-launch-mechanical-gerd-fix-in-us-IEEZJR7UTBCAVBLTCJ3ZR27ZDU/</guid><dc:creator><![CDATA[Elizabeth Orr]]></dc:creator><description><![CDATA[Implantica is launching RefluxStop in the US after a PMA approval that was based entirely on European trial data. A Medicare pass-through decision is expected in six to 12 months.<div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/nK17PeZF2nDGj3fA1fD6k7pkjAA=/cloudfront-us-east-1.images.arcpublishing.com/norstella/F3PVGGUG6ZCPRCR4ZK7XF6R3UQ.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/nK17PeZF2nDGj3fA1fD6k7pkjAA=/cloudfront-us-east-1.images.arcpublishing.com/norstella/F3PVGGUG6ZCPRCR4ZK7XF6R3UQ.jpg"/></a></div>
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</description><pubDate>Fri, 11 Sep 2026 18:17:24 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/nK17PeZF2nDGj3fA1fD6k7pkjAA=/cloudfront-us-east-1.images.arcpublishing.com/norstella/F3PVGGUG6ZCPRCR4ZK7XF6R3UQ.jpg" type="image/jpeg" height="675" width="1200"><media:description type="plain"><![CDATA[Implantica's RefluxStop takes a mechanical approach to the treatment of acid reflux.]]></media:description><media:credit role="author" scheme="urn:ebu">Panchenko Vladimir</media:credit></media:content></item>
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<feedburner:origLink>https://insights.citeline.com/medtech-insight/geography/europe/germany/german-industry-assesses-reimbursement-and-health-reform-challenges-as-bundestag-resumes-RZTOHKHE5ZAJHFUM2WSF4LPY74/</feedburner:origLink><title><![CDATA[German Industry Assesses Reimbursement And Health Reform Challenges As Bundestag Resumes ]]></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/968985188/0/medtech">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/968985188/0/medtech~German-Industry-Assesses-Reimbursement-And-Health-Reform-Challenges-As-Bundestag-Resumes/</link><guid isPermaLink="true">https://insights.citeline.com/medtech-insight/geography/europe/germany/german-industry-assesses-reimbursement-and-health-reform-challenges-as-bundestag-resumes-RZTOHKHE5ZAJHFUM2WSF4LPY74/</guid><dc:creator><![CDATA[Ashley Yeo]]></dc:creator><description><![CDATA[The German health system is broaching self-pay for certain diagnostics in certain settings. On one hand, it widens access, but on the other, patients’ inability or reluctance to pay might become a stumbling block.<div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/b1MXGusHTv6oiDrOMQMPmcc1YVs=/cloudfront-us-east-1.images.arcpublishing.com/norstella/24K2S7HNL5DUFBDMME4XLZZTKE.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/b1MXGusHTv6oiDrOMQMPmcc1YVs=/cloudfront-us-east-1.images.arcpublishing.com/norstella/24K2S7HNL5DUFBDMME4XLZZTKE.jpg"/></a></div>
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</description><pubDate>Fri, 11 Sep 2026 20:00:46 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/b1MXGusHTv6oiDrOMQMPmcc1YVs=/cloudfront-us-east-1.images.arcpublishing.com/norstella/24K2S7HNL5DUFBDMME4XLZZTKE.jpg" type="image/jpeg" height="4016" width="6016"><media:description type="plain"><![CDATA[No healthcare stakeholder will be spared the impact of the government's cost-containment measures]]></media:description></media:content></item>
<item>
<feedburner:origLink>https://insights.citeline.com/medtech-insight/leadership/interviews/bridge-to-lifes-110m-bet-on-making-hypothermic-perfusion-and-viability-testing-standard-of-care-2J3POHJXJVDVREOJ2TFD3J77MQ/</feedburner:origLink><title><![CDATA[Bridge To Life’s $110m Bet On Making Hypothermic Perfusion —And Viability Testing— Standard Of Care]]></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/968974220/0/medtech">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/968974220/0/medtech~Bridge-To-Life%e2%80%99s-m-Bet-On-Making-Hypothermic-Perfusion-%e2%80%94And-Viability-Testing%e2%80%94-Standard-Of-Care/</link><guid isPermaLink="true">https://insights.citeline.com/medtech-insight/leadership/interviews/bridge-to-lifes-110m-bet-on-making-hypothermic-perfusion-and-viability-testing-standard-of-care-2J3POHJXJVDVREOJ2TFD3J77MQ/</guid><dc:creator><![CDATA[Phalguni  Deswal]]></dc:creator><description><![CDATA[Bridge to Life closed a $110m Series C to fund a US commercial push for VitaSmart, its cold HOPE perfusion system, betting a simpler, cheaper workflow undercuts NMP rivals — with an FMN viability diagnostic, still in validation, as the intended moat.<div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/rkUe1qoZMzjggzwu2pL718LpYe8=/cloudfront-us-east-1.images.arcpublishing.com/norstella/NCNLYET4ZRGVPPP3Y7LAGRLYDU.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/rkUe1qoZMzjggzwu2pL718LpYe8=/cloudfront-us-east-1.images.arcpublishing.com/norstella/NCNLYET4ZRGVPPP3Y7LAGRLYDU.jpg"/></a></div>
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</description><pubDate>Fri, 11 Sep 2026 14:28:50 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/rkUe1qoZMzjggzwu2pL718LpYe8=/cloudfront-us-east-1.images.arcpublishing.com/norstella/NCNLYET4ZRGVPPP3Y7LAGRLYDU.jpg" type="image/jpeg" height="664" width="1000"><media:description type="plain"><![CDATA[VitaSmart received FDA De Novo clearance in January 2026 — the first US authorization for a cold (hypothermic) machine-perfusion device in liver transplantation, and a new device classification. ]]></media:description></media:content></item>
<item>
<feedburner:origLink>https://insights.citeline.com/medtech-insight/business/financing/plaque-plus-physiology-elucids-55m-series-d-funds-a-two-front-coronary-ai-push-ODFGPM5XURDGXJEGSI45VDE2YM/</feedburner:origLink><title><![CDATA[Plaque Plus Physiology: Elucid’s $55m Series D Funds A Two-Front Coronary AI Push]]></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/968965463/0/medtech">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/968965463/0/medtech~Plaque-Plus-Physiology-Elucid%e2%80%99s-m-Series-D-Funds-A-TwoFront-Coronary-AI-Push/</link><guid isPermaLink="true">https://insights.citeline.com/medtech-insight/business/financing/plaque-plus-physiology-elucids-55m-series-d-funds-a-two-front-coronary-ai-push-ODFGPM5XURDGXJEGSI45VDE2YM/</guid><dc:creator><![CDATA[Shubham Singh]]></dc:creator><description><![CDATA[Elucid has closed a $55m Series D to back a two-product platform strategy in coronary CT analysis — one tool measuring plaque already cleared, one measuring blood flow still under FDA review.<div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/vywahOp9oQgmESlWtSot40NUi30=/cloudfront-us-east-1.images.arcpublishing.com/norstella/A5POXUFXVFCK7FFD26PQVXR5IA.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/vywahOp9oQgmESlWtSot40NUi30=/cloudfront-us-east-1.images.arcpublishing.com/norstella/A5POXUFXVFCK7FFD26PQVXR5IA.jpg"/></a></div>
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</description><pubDate>Fri, 11 Sep 2026 12:45:01 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/vywahOp9oQgmESlWtSot40NUi30=/cloudfront-us-east-1.images.arcpublishing.com/norstella/A5POXUFXVFCK7FFD26PQVXR5IA.jpg" type="image/jpeg" height="675" width="1200"><media:description type="plain"><![CDATA[Plaque-IQ, cleared by the US Food and Drug Administration in 2024, converts coronary CT angiography scans into 3D models that classify plaque type and volume in coronary and carotid arteries, with accuracy validated against histopathology rather than CT attenuation thresholds alone. Picture Courtesy: Elucid]]></media:description></media:content></item>
<item>
<feedburner:origLink>https://insights.citeline.com/medtech-insight/geography/europe/germany/diagnostics-firms-expect-german-health-minister-to-deliver-on-market-access-and-dialog-agenda-GF2VZDWR5ZDNHAZTI36RADAVOE/</feedburner:origLink><title><![CDATA[Diagnostics Firms Expect German Health Minister To Deliver On Market Access And ‘Dialog’ Agenda ]]></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/968959841/0/medtech">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/968959841/0/medtech~Diagnostics-Firms-Expect-German-Health-Minister-To-Deliver-On-Market-Access-And-%e2%80%98Dialog%e2%80%99-Agenda/</link><guid isPermaLink="true">https://insights.citeline.com/medtech-insight/geography/europe/germany/diagnostics-firms-expect-german-health-minister-to-deliver-on-market-access-and-dialog-agenda-GF2VZDWR5ZDNHAZTI36RADAVOE/</guid><dc:creator><![CDATA[Ashley Yeo]]></dc:creator><description><![CDATA[Martin Walger sees change ahead for the German diagnostics industry, whose interests he has represented as head of the VDGH industry association since 2009. In a series of interviews, he describes an industry coping with financial realities, the EU IVDR, and first, adjusting to a new health minister<div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/ATCksCPWUTrB7__nmQvZPr-86Qc=/cloudfront-us-east-1.images.arcpublishing.com/norstella/H4T3QB3X5ZGIJED335JCF3LTCM.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/ATCksCPWUTrB7__nmQvZPr-86Qc=/cloudfront-us-east-1.images.arcpublishing.com/norstella/H4T3QB3X5ZGIJED335JCF3LTCM.jpg"/></a></div>
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</description><pubDate>Fri, 11 Sep 2026 09:30:11 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/ATCksCPWUTrB7__nmQvZPr-86Qc=/cloudfront-us-east-1.images.arcpublishing.com/norstella/H4T3QB3X5ZGIJED335JCF3LTCM.jpg" type="image/jpeg" height="667" width="1000"><media:description type="plain"><![CDATA[The German diagnostics industry is ready to work with policy stakeholders to secure positive change]]></media:description></media:content></item>
<item>
<feedburner:origLink>https://insights.citeline.com/medtech-insight/policy-and-regulation/legalandip/ex-us-fda-chief-counsel-mark-raza-joins-hogan-lovells-cadwalader-ZZ4DHGLI3ZFFDOUFXPS5I47IFE/</feedburner:origLink><title><![CDATA[Ex-US FDA Chief Counsel Mark Raza Joins Hogan Lovells Cadwalader]]></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/968939501/0/medtech">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/968939501/0/medtech~ExUS-FDA-Chief-Counsel-Mark-Raza-Joins-Hogan-Lovells-Cadwalader/</link><guid isPermaLink="true">https://insights.citeline.com/medtech-insight/policy-and-regulation/legalandip/ex-us-fda-chief-counsel-mark-raza-joins-hogan-lovells-cadwalader-ZZ4DHGLI3ZFFDOUFXPS5I47IFE/</guid><dc:creator><![CDATA[Sue Sutter]]></dc:creator><description><![CDATA[Raza spent more than 35 years at the FDA, including four years as chief counsel, before retiring from the agency in spring 2025.<div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/gcR_ljpIkpk0XBD0wkcHlKoHuAE=/cloudfront-us-east-1.images.arcpublishing.com/norstella/YKPCP5I6FNFGNGZZMLGYPDZVGU.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/gcR_ljpIkpk0XBD0wkcHlKoHuAE=/cloudfront-us-east-1.images.arcpublishing.com/norstella/YKPCP5I6FNFGNGZZMLGYPDZVGU.jpg"/></a></div>
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</description><pubDate>Thu, 10 Sep 2026 20:05:28 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/gcR_ljpIkpk0XBD0wkcHlKoHuAE=/cloudfront-us-east-1.images.arcpublishing.com/norstella/YKPCP5I6FNFGNGZZMLGYPDZVGU.jpg" type="image/jpeg" height="2843" width="3990"><media:description type="plain"><![CDATA[Mark Raza is the second former agency official to join Hogan Lovells Cadwalader in the past month.]]></media:description><media:credit role="author" scheme="urn:ebu">Billion Photos</media:credit></media:content></item>
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<feedburner:origLink>https://insights.citeline.com/medtech-insight/device-area/surgery/robotic-surgery/xcath-robotics-receives-fda-breakthrough-device-designation-for-endovascular-robot-YXQ5FFS36FED7ANM6JLEGBGMZ4/</feedburner:origLink><title><![CDATA[XCath Robotics Receives FDA Breakthrough Device Designation For Endovascular Robot]]></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/968933336/0/medtech">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/968933336/0/medtech~XCath-Robotics-Receives-FDA-Breakthrough-Device-Designation-For-Endovascular-Robot/</link><guid isPermaLink="true">https://insights.citeline.com/medtech-insight/device-area/surgery/robotic-surgery/xcath-robotics-receives-fda-breakthrough-device-designation-for-endovascular-robot-YXQ5FFS36FED7ANM6JLEGBGMZ4/</guid><dc:creator><![CDATA[Marion Webb]]></dc:creator><description><![CDATA[XCath Robotics has received FDA breakthrough device designation for its Iris Surgical Robotic System. The product is the only endovascular robotic system under development to achieve intracranial navigation for neurointerventional treatments such as stroke and aneurysm care.<div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/zhhfXBD1vKQN_jGaVYUxkOlrhH8=/cloudfront-us-east-1.images.arcpublishing.com/norstella/ZB75NU6H2BE2XB2XJTUTO6QAVA.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/zhhfXBD1vKQN_jGaVYUxkOlrhH8=/cloudfront-us-east-1.images.arcpublishing.com/norstella/ZB75NU6H2BE2XB2XJTUTO6QAVA.jpg"/></a></div>
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</description><pubDate>Thu, 10 Sep 2026 15:59:45 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/zhhfXBD1vKQN_jGaVYUxkOlrhH8=/cloudfront-us-east-1.images.arcpublishing.com/norstella/ZB75NU6H2BE2XB2XJTUTO6QAVA.jpg" type="image/jpeg" height="4320" width="7680"><media:description type="plain"><![CDATA[XCath Robotics announced it received FDA breakthrough device designation for its endovascular robotic system. This comes after it successfully completed the world’s first telerobotic stroke procedure using the investigational Iris system.]]></media:description></media:content></item>
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<feedburner:origLink>https://insights.citeline.com/medtech-insight/leadership/execs-on-the-move-august-31september-4-2026-D3M3KXYS3ZBDDPE3QHN6MOKBYM/</feedburner:origLink><title><![CDATA[Execs On The Move: August 31–September 4, 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/968928767/0/medtech">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/968928767/0/medtech~Execs-On-The-Move-August-%e2%80%93September/</link><guid isPermaLink="true">https://insights.citeline.com/medtech-insight/leadership/execs-on-the-move-august-31september-4-2026-D3M3KXYS3ZBDDPE3QHN6MOKBYM/</guid><dc:creator><![CDATA[Medtech Insight Team]]></dc:creator><description><![CDATA[An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.<div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/h4fVGgwOIyO4RzeYcyFoc_E91Qo=/cloudfront-us-east-1.images.arcpublishing.com/norstella/QSTAM7SGMJOYTGEBU2RZSDKLYA.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/h4fVGgwOIyO4RzeYcyFoc_E91Qo=/cloudfront-us-east-1.images.arcpublishing.com/norstella/QSTAM7SGMJOYTGEBU2RZSDKLYA.jpg"/></a></div>
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</description><pubDate>Thu, 10 Sep 2026 13:50:13 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/h4fVGgwOIyO4RzeYcyFoc_E91Qo=/cloudfront-us-east-1.images.arcpublishing.com/norstella/QSTAM7SGMJOYTGEBU2RZSDKLYA.jpg" type="image/jpeg" height="675" width="1200"><media:credit role="author" scheme="urn:ebu"></media:credit></media:content></item>
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<feedburner:origLink>https://insights.citeline.com/medtech-insight/digital-technologies/ai/ai-devices-could-get-faster-uk-regulation-in-exchange-for-lifelong-monitoring-73RLATSAUFC2BMX7JSD2JS657A/</feedburner:origLink><title><![CDATA[AI Devices Could Get Faster UK Regulation – In Exchange For Lifelong Monitoring]]></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/968918093/0/medtech">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/968918093/0/medtech~AI-Devices-Could-Get-Faster-UK-Regulation-%e2%80%93-In-Exchange-For-Lifelong-Monitoring/</link><guid isPermaLink="true">https://insights.citeline.com/medtech-insight/digital-technologies/ai/ai-devices-could-get-faster-uk-regulation-in-exchange-for-lifelong-monitoring-73RLATSAUFC2BMX7JSD2JS657A/</guid><dc:creator><![CDATA[George Underwood]]></dc:creator><description><![CDATA[Independent commission asks MHRA to introduce staged authorization, continuous monitoring and tougher enforcement for AI medtech in the UK. <div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/c2SpjUcnYYHAZzJS7yi8UR2U8E4=/cloudfront-us-east-1.images.arcpublishing.com/norstella/C426PC7MVBOMZINMADIFYQEWVI.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/c2SpjUcnYYHAZzJS7yi8UR2U8E4=/cloudfront-us-east-1.images.arcpublishing.com/norstella/C426PC7MVBOMZINMADIFYQEWVI.jpg"/></a></div>
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</description><pubDate>Thu, 10 Sep 2026 11:36:57 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/c2SpjUcnYYHAZzJS7yi8UR2U8E4=/cloudfront-us-east-1.images.arcpublishing.com/norstella/C426PC7MVBOMZINMADIFYQEWVI.jpg" type="image/jpeg" height="348" width="620"/></item>
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<feedburner:origLink>https://insights.citeline.com/medtech-insight/device-area/neurology/smartphones-could-detect-alzheimers-symptoms-to-improve-screening-blood-tests-OIPFUSDBKFFEZDT3FTFATAPXYM/</feedburner:origLink><title><![CDATA[Smartphones Could Detect Alzheimer’s Symptoms To Improve Screening, Blood Tests]]></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/968910869/0/medtech">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/968910869/0/medtech~Smartphones-Could-Detect-Alzheimer%e2%80%99s-Symptoms-To-Improve-Screening-Blood-Tests/</link><guid isPermaLink="true">https://insights.citeline.com/medtech-insight/device-area/neurology/smartphones-could-detect-alzheimers-symptoms-to-improve-screening-blood-tests-OIPFUSDBKFFEZDT3FTFATAPXYM/</guid><dc:creator><![CDATA[George Underwood]]></dc:creator><description><![CDATA[Evidence is growing for digital measures of cognitive decline including speech tracking, eye movements and spatial navigation – but pharma skepticism remains. <div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/xEgbhgr-SRWY9dh1MNYmwMb8iEU=/cloudfront-us-east-1.images.arcpublishing.com/norstella/U3RG4W4BJBGRFE2TSGXAOEC2S4.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/xEgbhgr-SRWY9dh1MNYmwMb8iEU=/cloudfront-us-east-1.images.arcpublishing.com/norstella/U3RG4W4BJBGRFE2TSGXAOEC2S4.jpg"/></a></div>
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</description><pubDate>Thu, 10 Sep 2026 08:19:25 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/xEgbhgr-SRWY9dh1MNYmwMb8iEU=/cloudfront-us-east-1.images.arcpublishing.com/norstella/U3RG4W4BJBGRFE2TSGXAOEC2S4.jpg" type="image/jpeg" height="4672" width="7008"/></item>
<item>
<feedburner:origLink>https://insights.citeline.com/medtech-insight/digital-technologies/ai/seehafer-selection-as-first-deputy-commissioner-of-technology-and-ai-draws-praise-questions-EJD764DHONDR5HZMPZMMU5AOHQ/</feedburner:origLink><title><![CDATA[Seehafer Selection As First Deputy Commissioner Of Technology And AI Draws Praise, Questions ]]></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/968894348/0/medtech">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/968894348/0/medtech~Seehafer-Selection-As-First-Deputy-Commissioner-Of-Technology-And-AI-Draws-Praise-Questions/</link><guid isPermaLink="true">https://insights.citeline.com/medtech-insight/digital-technologies/ai/seehafer-selection-as-first-deputy-commissioner-of-technology-and-ai-draws-praise-questions-EJD764DHONDR5HZMPZMMU5AOHQ/</guid><dc:creator><![CDATA[Brian Bossetta]]></dc:creator><description><![CDATA[The FDA’s appointment of Jared Seehafer as its first deputy commissioner for technology and AI is attracting a mixed bag of approval and caution. Supporters cite his regulatory and technology experience, while some question his investment background. <div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/QTDl6oDDmIpghSIoPusPZq6N-uo=/cloudfront-us-east-1.images.arcpublishing.com/norstella/ULX4GVYJ4ZDUPHKA7OK7XTRWWY.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/QTDl6oDDmIpghSIoPusPZq6N-uo=/cloudfront-us-east-1.images.arcpublishing.com/norstella/ULX4GVYJ4ZDUPHKA7OK7XTRWWY.jpg"/></a></div>
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</description><pubDate>Wed, 09 Sep 2026 21:17:52 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/QTDl6oDDmIpghSIoPusPZq6N-uo=/cloudfront-us-east-1.images.arcpublishing.com/norstella/ULX4GVYJ4ZDUPHKA7OK7XTRWWY.jpg" type="image/jpeg" height="675" width="1200"/></item>
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<feedburner:origLink>https://insights.citeline.com/medtech-insight/policy-and-regulation/fda-opens-510k-pathway-for-eight-device-types-AXCEYCPSYNGIJC63XAMXQV32MY/</feedburner:origLink><title><![CDATA[FDA Opens 510(k) Pathway for Eight Device Types]]></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/968889518/0/medtech">
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</contentRestrictions><link>https://feeds.feedblitz.com/~/968889518/0/medtech~FDA-Opens-k-Pathway-for-Eight-Device-Types/</link><guid isPermaLink="true">https://insights.citeline.com/medtech-insight/policy-and-regulation/fda-opens-510k-pathway-for-eight-device-types-AXCEYCPSYNGIJC63XAMXQV32MY/</guid><dc:creator><![CDATA[Elizabeth Orr]]></dc:creator><description><![CDATA[The latest batch of FDA classification orders includes foam that protects reproductive organs during radiation therapy, an ENT robotic platform, and an implant to treat urinary incontinence.<div class="fbz_enclosure" style="clear:left"><a href="https://insights.citeline.com/resizer/G70tdZO5-NGuJCsgxS6BrPYwuvg=/cloudfront-us-east-1.images.arcpublishing.com/norstella/5KEXZOADLZCDDI4IQZJNOTSP5U.jpg" title="View image"><img border="0" style="max-width:100%" src="https://insights.citeline.com/resizer/G70tdZO5-NGuJCsgxS6BrPYwuvg=/cloudfront-us-east-1.images.arcpublishing.com/norstella/5KEXZOADLZCDDI4IQZJNOTSP5U.jpg"/></a></div>
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</description><pubDate>Wed, 09 Sep 2026 18:23:30 +0000</pubDate><media:content url="https://insights.citeline.com/resizer/G70tdZO5-NGuJCsgxS6BrPYwuvg=/cloudfront-us-east-1.images.arcpublishing.com/norstella/5KEXZOADLZCDDI4IQZJNOTSP5U.jpg" type="image/jpeg" height="666" width="1000"><media:description type="plain"><![CDATA[Devices from manufacturers including Galen Robotics, Laminate Medical and Xenex Disinfection Services received Class II status.]]></media:description></media:content></item>
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