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Medical Design and Outsourcing
<?xml version="1.0" encoding="UTF-8"?><rss version="2.0" xmlns:content="http://purl.org/rss/1.0/modules/content/" xmlns:wfw="http://wellformedweb.org/CommentAPI/" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:atom="http://www.w3.org/2005/Atom" xmlns:sy="http://purl.org/rss/1.0/modules/syndication/" xmlns:slash="http://purl.org/rss/1.0/modules/slash/" > <channel> <title>Medical Design and Outsourcing</title> <atom:link href="http://www.medicaldesignandoutsourcing.com/feed/" rel="self" type="application/rss+xml" /> <link>https://www.medicaldesignandoutsourcing.com/</link> <description>Design, development & contract manufacturing news coverage of medical devices & equipment</description> <lastBuildDate>Fri, 22 Nov 2024 23:12:24 +0000</lastBuildDate> <language>en-US</language> <sy:updatePeriod> hourly </sy:updatePeriod> <sy:updateFrequency> 1 </sy:updateFrequency> <generator>https://wordpress.org/?v=6.7</generator> <image> <url>https://www.medicaldesignandoutsourcing.com/wp-content/uploads/2019/02/cropped-MDO_favicon_2-19-32x32.jpg</url> <title>Medical Design and Outsourcing</title> <link>https://www.medicaldesignandoutsourcing.com/</link> <width>32</width> <height>32</height> </image> <item> <title>Faster breakthrough device coverage might be on the way</title> <link>https://www.medicaldesignandoutsourcing.com/faster-fda-breakthrough-device-coverage-medicare-legislation/</link> <comments>https://www.medicaldesignandoutsourcing.com/faster-fda-breakthrough-device-coverage-medicare-legislation/#respond</comments> <dc:creator><![CDATA[Jim Hammerand]]></dc:creator> <pubDate>Fri, 22 Nov 2024 17:15:29 +0000</pubDate> <category><![CDATA[FDA]]></category> <category><![CDATA[News]]></category> <category><![CDATA[Regulatory]]></category> <category><![CDATA[Reimbursement]]></category> <category><![CDATA[advamed]]></category> <guid isPermaLink="false">https://www.medicaldesignandoutsourcing.com/?p=274224</guid> <description><![CDATA[<p>Medical devices and diagnostics tests with FDA breakthrough designation would get faster Medicare coverage if new federal legislation becomes law. Two U.S. senators — Indiana Republican Todd Young and California Democrat Alex Padilla — have introduced the latest version of the Ensuring Patient Access to Critical Breakthrough Products Act of 2024, following the U.S. House…</p> <p>The post <a href="https://www.medicaldesignandoutsourcing.com/faster-fda-breakthrough-device-coverage-medicare-legislation/">Faster breakthrough device coverage might be on the way</a> appeared first on <a href="https://www.medicaldesignandoutsourcing.com">Medical Design and Outsourcing</a>.</p> ]]></description> <wfw:commentRss>https://www.medicaldesignandoutsourcing.com/faster-fda-breakthrough-device-coverage-medicare-legislation/feed/</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>Researchers develop wearable ultrasound patch for continuous noninvasive blood pressure monitoring</title> <link>https://www.medicaldesignandoutsourcing.com/researchers-develop-ultrasound-blood-pressure-monitoring-patch/</link> <comments>https://www.medicaldesignandoutsourcing.com/researchers-develop-ultrasound-blood-pressure-monitoring-patch/#respond</comments> <dc:creator><![CDATA[Sean Whooley]]></dc:creator> <pubDate>Fri, 22 Nov 2024 15:44:54 +0000</pubDate> <category><![CDATA[News]]></category> <category><![CDATA[ucsd]]></category> <category><![CDATA[University of California San Diego]]></category> <guid isPermaLink="false">https://www.medicaldesignandoutsourcing.com/?p=274221</guid> <description><![CDATA[<p>Researchers at the University of California San Diego say they developed a new, improved wearable ultrasound patch for monitoring blood pressure. The researchers say it’s the first wearable ultrasound blood pressure sensor to undergo rigorous and comprehensive clinical validation on over 100 patients. According to the researchers, the patch could improve the quality of cardiovascular…</p> <p>The post <a href="https://www.medicaldesignandoutsourcing.com/researchers-develop-ultrasound-blood-pressure-monitoring-patch/">Researchers develop wearable ultrasound patch for continuous noninvasive blood pressure monitoring</a> appeared first on <a href="https://www.medicaldesignandoutsourcing.com">Medical Design and Outsourcing</a>.</p> ]]></description> <wfw:commentRss>https://www.medicaldesignandoutsourcing.com/researchers-develop-ultrasound-blood-pressure-monitoring-patch/feed/</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>Syensqo expands medtech polymer production capacity</title> <link>https://www.medicaldesignandoutsourcing.com/syensqo-expands-udel-polysulfone-polymer-production-capacity/</link> <comments>https://www.medicaldesignandoutsourcing.com/syensqo-expands-udel-polysulfone-polymer-production-capacity/#respond</comments> <dc:creator><![CDATA[MDO Staff]]></dc:creator> <pubDate>Thu, 21 Nov 2024 22:50:58 +0000</pubDate> <category><![CDATA[Manufacturing]]></category> <category><![CDATA[News]]></category> <category><![CDATA[Polymers]]></category> <category><![CDATA[Syensqo]]></category> <guid isPermaLink="false">https://www.medicaldesignandoutsourcing.com/?p=274218</guid> <description><![CDATA[<p>NEWS RELEASE: Syensqo expands polymer production capacity for life-saving and life-supporting applications Boosted U.S. production addresses rising demand for high-performance materials in healthcare, water filtration, and renewable energy markets Alpharetta, Georgia — Syensqo, a global leader in high-performance materials, has significantly increased its U.S. production capacity for advanced polymers used in critical health, water, and…</p> <p>The post <a href="https://www.medicaldesignandoutsourcing.com/syensqo-expands-udel-polysulfone-polymer-production-capacity/">Syensqo expands medtech polymer production capacity</a> appeared first on <a href="https://www.medicaldesignandoutsourcing.com">Medical Design and Outsourcing</a>.</p> ]]></description> <wfw:commentRss>https://www.medicaldesignandoutsourcing.com/syensqo-expands-udel-polysulfone-polymer-production-capacity/feed/</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>Can Maryland make Baltimore the next medtech hub?</title> <link>https://www.medicaldesignandoutsourcing.com/can-maryland-make-baltimore-the-next-medtech-hub/</link> <comments>https://www.medicaldesignandoutsourcing.com/can-maryland-make-baltimore-the-next-medtech-hub/#respond</comments> <dc:creator><![CDATA[Jim Hammerand]]></dc:creator> <pubDate>Thu, 21 Nov 2024 22:00:23 +0000</pubDate> <category><![CDATA[FDA]]></category> <category><![CDATA[Funding]]></category> <category><![CDATA[Manufacturing]]></category> <category><![CDATA[Medical Device Business]]></category> <category><![CDATA[News]]></category> <category><![CDATA[Regulatory]]></category> <category><![CDATA[Reimbursement]]></category> <category><![CDATA[Centers for Medicare and Medicaid Services (CMS)]]></category> <category><![CDATA[CMS]]></category> <category><![CDATA[Department of Defense]]></category> <category><![CDATA[fda]]></category> <category><![CDATA[Howard University]]></category> <category><![CDATA[Johns Hopkins University]]></category> <category><![CDATA[maryland department of commerce]]></category> <category><![CDATA[National Cancer Institute]]></category> <category><![CDATA[nih]]></category> <category><![CDATA[University of Maryland]]></category> <guid isPermaLink="false">https://www.medicaldesignandoutsourcing.com/?p=274191</guid> <description><![CDATA[<p>If you’re a medical device manufacturer with plans to expand or a medtech founder looking for somewhere to get started, the Maryland Department of Commerce would like to have a word about Baltimore. They’re hoping Maryland’s largest city and the surrounding regions can join Boston, Minneapolis and the San Francisco Bay Area as a medtech…</p> <p>The post <a href="https://www.medicaldesignandoutsourcing.com/can-maryland-make-baltimore-the-next-medtech-hub/">Can Maryland make Baltimore the next medtech hub?</a> appeared first on <a href="https://www.medicaldesignandoutsourcing.com">Medical Design and Outsourcing</a>.</p> ]]></description> <wfw:commentRss>https://www.medicaldesignandoutsourcing.com/can-maryland-make-baltimore-the-next-medtech-hub/feed/</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>Merz Therapeutics and S3 Connected Health launch iFlexo</title> <link>https://www.medicaldesignandoutsourcing.com/merz-therapeutics-and-s3-connected-health-launch-iflexo/</link> <comments>https://www.medicaldesignandoutsourcing.com/merz-therapeutics-and-s3-connected-health-launch-iflexo/#respond</comments> <dc:creator><![CDATA[MDO Staff]]></dc:creator> <pubDate>Thu, 21 Nov 2024 18:47:36 +0000</pubDate> <category><![CDATA[Devices]]></category> <category><![CDATA[Digital health]]></category> <category><![CDATA[News]]></category> <category><![CDATA[Merz Therapeutics]]></category> <category><![CDATA[S3 Connected Health]]></category> <guid isPermaLink="false">https://www.medicaldesignandoutsourcing.com/?p=274209</guid> <description><![CDATA[<p>NEWS RELEASE: Merz Therapeutics and S3 Connected Health Pioneer New Digital Health Solution, iFlexo, for People Living with Post-Stroke Spasticity Dublin/Frankfurt — Merz Therapeutics launches iFlexo, a personalized digital solution aimed at enhancing rehabilitation for people with post-stroke spasticity as part of its ongoing commitment to supporting stroke survivors. The app, developed in collaboration with…</p> <p>The post <a href="https://www.medicaldesignandoutsourcing.com/merz-therapeutics-and-s3-connected-health-launch-iflexo/">Merz Therapeutics and S3 Connected Health launch iFlexo</a> appeared first on <a href="https://www.medicaldesignandoutsourcing.com">Medical Design and Outsourcing</a>.</p> ]]></description> <wfw:commentRss>https://www.medicaldesignandoutsourcing.com/merz-therapeutics-and-s3-connected-health-launch-iflexo/feed/</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>Perimeter Medical Imaging AI announces pivotal study results for B-Series OCT with ImgAssist AI 2.0</title> <link>https://www.medicaldesignandoutsourcing.com/perimeter-medical-imaging-ai-pivotal-study-results-b-series-oct-imgassist-2/</link> <comments>https://www.medicaldesignandoutsourcing.com/perimeter-medical-imaging-ai-pivotal-study-results-b-series-oct-imgassist-2/#respond</comments> <dc:creator><![CDATA[MDO Staff]]></dc:creator> <pubDate>Thu, 21 Nov 2024 17:09:28 +0000</pubDate> <category><![CDATA[Artificial intelligence]]></category> <category><![CDATA[Clinical Trials]]></category> <category><![CDATA[Imaging]]></category> <category><![CDATA[News]]></category> <category><![CDATA[Perimeter Medical Imaging AI]]></category> <guid isPermaLink="false">https://www.medicaldesignandoutsourcing.com/?p=274205</guid> <description><![CDATA[<p>NEWS RELEASE: Perimeter B-Series OCT with ImgAssist AI 2.0 Demonstrates Super-Superiority Compared to Standard-of-Care in Pivotal Clinical Trial Intraoperative margin assessment during BCS using Perimeter B-Series OCT with ImgAssist AI 2.0 enabled surgeons to more effectively address residual cancer at the surgical margin as compared to current standard methods Primary endpoint met with statistically significant…</p> <p>The post <a href="https://www.medicaldesignandoutsourcing.com/perimeter-medical-imaging-ai-pivotal-study-results-b-series-oct-imgassist-2/">Perimeter Medical Imaging AI announces pivotal study results for B-Series OCT with ImgAssist AI 2.0</a> appeared first on <a href="https://www.medicaldesignandoutsourcing.com">Medical Design and Outsourcing</a>.</p> ]]></description> <wfw:commentRss>https://www.medicaldesignandoutsourcing.com/perimeter-medical-imaging-ai-pivotal-study-results-b-series-oct-imgassist-2/feed/</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>Weiss-Aug Group expands manufacturing capabilities with Precision Tech</title> <link>https://www.medicaldesignandoutsourcing.com/weiss-aug-grou-precision-tech-machining/</link> <comments>https://www.medicaldesignandoutsourcing.com/weiss-aug-grou-precision-tech-machining/#respond</comments> <dc:creator><![CDATA[MDO Staff]]></dc:creator> <pubDate>Wed, 20 Nov 2024 22:20:37 +0000</pubDate> <category><![CDATA[Contract Manufacturing]]></category> <category><![CDATA[Machining]]></category> <category><![CDATA[News]]></category> <category><![CDATA[Precision Tech]]></category> <category><![CDATA[Weiss-Aug Group]]></category> <guid isPermaLink="false">https://www.medicaldesignandoutsourcing.com/?p=274197</guid> <description><![CDATA[<p>NEWS RELEASE: Weiss-Aug Group Expands Manufacturing Capabilities with Precision Tech, its New Precision Machining Center of Excellence Precision Tech specializes in machining of high-precision components on multi-axis CNC machining centers and multi-spindle Swiss screw machines. NEW KENSINGTON, PA — Weiss-Aug Group, an industry leader with 50 years of expertise in precision metal stamping, injection molding,…</p> <p>The post <a href="https://www.medicaldesignandoutsourcing.com/weiss-aug-grou-precision-tech-machining/">Weiss-Aug Group expands manufacturing capabilities with Precision Tech</a> appeared first on <a href="https://www.medicaldesignandoutsourcing.com">Medical Design and Outsourcing</a>.</p> ]]></description> <wfw:commentRss>https://www.medicaldesignandoutsourcing.com/weiss-aug-grou-precision-tech-machining/feed/</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>Abbott expands Diversity in Clinical Trials initiative with new recommendations and partnerships</title> <link>https://www.medicaldesignandoutsourcing.com/abbott-expands-diversity-clinical-trials-initiative/</link> <comments>https://www.medicaldesignandoutsourcing.com/abbott-expands-diversity-clinical-trials-initiative/#respond</comments> <dc:creator><![CDATA[Danielle Kirsh]]></dc:creator> <pubDate>Wed, 20 Nov 2024 22:13:38 +0000</pubDate> <category><![CDATA[Clinical Trials]]></category> <category><![CDATA[Regulatory]]></category> <category><![CDATA[Abbott]]></category> <guid isPermaLink="false">https://www.medicaldesignandoutsourcing.com/?p=274200</guid> <description><![CDATA[<p>Abbott has released a report, Advancing Diversity in Clinical Trials, outlining strategies to address key barriers to diverse participation in clinical research, including lack of trust, transparency, access and common language. The report marks the third year of Abbott’s multimillion-dollar Diversity in Clinical Trials initiative. The report offers actionable recommendations and insights from nearly 100 experts, including…</p> <p>The post <a href="https://www.medicaldesignandoutsourcing.com/abbott-expands-diversity-clinical-trials-initiative/">Abbott expands Diversity in Clinical Trials initiative with new recommendations and partnerships</a> appeared first on <a href="https://www.medicaldesignandoutsourcing.com">Medical Design and Outsourcing</a>.</p> ]]></description> <wfw:commentRss>https://www.medicaldesignandoutsourcing.com/abbott-expands-diversity-clinical-trials-initiative/feed/</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>Medtronic launches study to address health disparities in structural heart disease</title> <link>https://www.medicaldesignandoutsourcing.com/medtronic-launches-study-to-address-health-disparities-in-structural-heart-disease/</link> <comments>https://www.medicaldesignandoutsourcing.com/medtronic-launches-study-to-address-health-disparities-in-structural-heart-disease/#respond</comments> <dc:creator><![CDATA[Danielle Kirsh]]></dc:creator> <pubDate>Wed, 20 Nov 2024 21:18:32 +0000</pubDate> <category><![CDATA[Artificial intelligence]]></category> <category><![CDATA[Cardiovascular]]></category> <category><![CDATA[Clinical Trials]]></category> <category><![CDATA[Research & Development]]></category> <category><![CDATA[Health equity]]></category> <category><![CDATA[medtronic]]></category> <guid isPermaLink="false">https://www.medicaldesignandoutsourcing.com/?p=274195</guid> <description><![CDATA[<p>Medtronic has announced the launch of a study to address racial, ethnic, gender and geographic disparities in heart disease treatment. The study, called ALERT (for “Addressing undertreatment and heaLth Equity in aortic stenosis and mitral regurgitation using an integrated ehR plaTform”) and sponsored by health technology company Tempus, will use AI to identify patients with…</p> <p>The post <a href="https://www.medicaldesignandoutsourcing.com/medtronic-launches-study-to-address-health-disparities-in-structural-heart-disease/">Medtronic launches study to address health disparities in structural heart disease</a> appeared first on <a href="https://www.medicaldesignandoutsourcing.com">Medical Design and Outsourcing</a>.</p> ]]></description> <wfw:commentRss>https://www.medicaldesignandoutsourcing.com/medtronic-launches-study-to-address-health-disparities-in-structural-heart-disease/feed/</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>FDA to address regulatory challenges for generative AI in medtech</title> <link>https://www.medicaldesignandoutsourcing.com/fda-to-address-regulatory-challenges-for-generative-ai-in-medtech/</link> <comments>https://www.medicaldesignandoutsourcing.com/fda-to-address-regulatory-challenges-for-generative-ai-in-medtech/#respond</comments> <dc:creator><![CDATA[Danielle Kirsh]]></dc:creator> <pubDate>Wed, 20 Nov 2024 17:27:43 +0000</pubDate> <category><![CDATA[Artificial intelligence]]></category> <category><![CDATA[FDA]]></category> <category><![CDATA[Medical Device Business]]></category> <category><![CDATA[Regulatory]]></category> <category><![CDATA[fda]]></category> <category><![CDATA[generative AI]]></category> <guid isPermaLink="false">https://www.medicaldesignandoutsourcing.com/?p=274192</guid> <description><![CDATA[<p>The FDA will discuss a new framework for regulating generative-AI-enabled devices during a Digital Health Advisory Committee meeting this week. The advisory committee is meeting Nov. 20–21 to address the balance between encouraging innovation and ensuring safety for this emerging technology that is reshaping the medical device industry. According to the FDA, generative artificial intelligence…</p> <p>The post <a href="https://www.medicaldesignandoutsourcing.com/fda-to-address-regulatory-challenges-for-generative-ai-in-medtech/">FDA to address regulatory challenges for generative AI in medtech</a> appeared first on <a href="https://www.medicaldesignandoutsourcing.com">Medical Design and Outsourcing</a>.</p> ]]></description> <wfw:commentRss>https://www.medicaldesignandoutsourcing.com/fda-to-address-regulatory-challenges-for-generative-ai-in-medtech/feed/</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>Precision Machining for Complex Geometries</title> <link>https://www.medicaldesignandoutsourcing.com/precision-machining-for-complex-geometries/</link> <comments>https://www.medicaldesignandoutsourcing.com/precision-machining-for-complex-geometries/#respond</comments> <dc:creator><![CDATA[Sponsored Content]]></dc:creator> <pubDate>Wed, 20 Nov 2024 15:01:05 +0000</pubDate> <category><![CDATA[Sponsored Content]]></category> <category><![CDATA[Vantedge Medical]]></category> <guid isPermaLink="false">https://www.medicaldesignandoutsourcing.com/?p=274081</guid> <description><![CDATA[<p>By Shawn Murphy, Director of Advanced Technology, Hobson & Motzer, LLC, a Vantedge Medical Company In today’s dynamic medical device manufacturing sector, precision is everything. Instruments used by surgeons, as well as devices that improve patient outcomes, often rely on intricate designs and flawless finishes. Manufacturers must ensure that every component produced for medical use…</p> <p>The post <a href="https://www.medicaldesignandoutsourcing.com/precision-machining-for-complex-geometries/">Precision Machining for Complex Geometries</a> appeared first on <a href="https://www.medicaldesignandoutsourcing.com">Medical Design and Outsourcing</a>.</p> ]]></description> <wfw:commentRss>https://www.medicaldesignandoutsourcing.com/precision-machining-for-complex-geometries/feed/</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>What is nitinol and where is it used?</title> <link>https://www.medicaldesignandoutsourcing.com/what-is-nitinol-and-where-is-it-used/</link> <comments>https://www.medicaldesignandoutsourcing.com/what-is-nitinol-and-where-is-it-used/#comments</comments> <dc:creator><![CDATA[Jim Hammerand]]></dc:creator> <pubDate>Wed, 20 Nov 2024 13:33:02 +0000</pubDate> <category><![CDATA[Advanced Materials]]></category> <category><![CDATA[Cardiovascular]]></category> <category><![CDATA[Implantables]]></category> <category><![CDATA[Materials]]></category> <category><![CDATA[Metals]]></category> <category><![CDATA[Orthopedic]]></category> <category><![CDATA[Surgical]]></category> <category><![CDATA[Abbott]]></category> <category><![CDATA[Ablative Solutions]]></category> <category><![CDATA[Affera]]></category> <category><![CDATA[Biosense Webster]]></category> <category><![CDATA[Boston Scientific]]></category> <category><![CDATA[fda]]></category> <category><![CDATA[medtronic]]></category> <category><![CDATA[nitinol]]></category> <category><![CDATA[synchron]]></category> <guid isPermaLink="false">http://www.medicaldesignandoutsourcing.com/?p=206050</guid> <description><![CDATA[<p>Nitinol is a nearly equiatomic metal alloy of nickel and titanium with unique properties, including superelasticity (also called pseudoelasticity) and shape memory. Superelasticity/pseudoelasticity means medical-grade nitinol shows great elasticity under stress and can snap back to its original shape when pressure is released. Nitinol’s superelastic properties allow medical devices using it to compress to a lower…</p> <p>The post <a href="https://www.medicaldesignandoutsourcing.com/what-is-nitinol-and-where-is-it-used/">What is nitinol and where is it used?</a> appeared first on <a href="https://www.medicaldesignandoutsourcing.com">Medical Design and Outsourcing</a>.</p> ]]></description> <wfw:commentRss>https://www.medicaldesignandoutsourcing.com/what-is-nitinol-and-where-is-it-used/feed/</wfw:commentRss> <slash:comments>1</slash:comments> </item> <item> <title>A surgical robotics co-founder offers lessons from the de novo pathway</title> <link>https://www.medicaldesignandoutsourcing.com/cmr-surgical-mark-slack-fda-de-novo-advice-versius-surgical-robot/</link> <comments>https://www.medicaldesignandoutsourcing.com/cmr-surgical-mark-slack-fda-de-novo-advice-versius-surgical-robot/#respond</comments> <dc:creator><![CDATA[Jim Hammerand]]></dc:creator> <pubDate>Tue, 19 Nov 2024 21:53:40 +0000</pubDate> <category><![CDATA[Clinical Trials]]></category> <category><![CDATA[Cybersecurity]]></category> <category><![CDATA[Data]]></category> <category><![CDATA[FDA]]></category> <category><![CDATA[News]]></category> <category><![CDATA[Regulatory]]></category> <category><![CDATA[CMR Surgical]]></category> <category><![CDATA[de novo]]></category> <category><![CDATA[real-world data]]></category> <category><![CDATA[real-world evidence]]></category> <category><![CDATA[surgical robot]]></category> <category><![CDATA[surgical robotics]]></category> <guid isPermaLink="false">https://www.medicaldesignandoutsourcing.com/?p=274177</guid> <description><![CDATA[<p>Just more than a decade after CMR Surgical‘s founding, the surgical robotics developer won FDA de novo authorization for its multi-port, soft tissue Versius platform in October 2024. When announcing the regulatory milestone, CMR Surgical said Versius (which had a CE mark since 2019) was already the world’s second-most-utilized surgical robotic system, with more than…</p> <p>The post <a href="https://www.medicaldesignandoutsourcing.com/cmr-surgical-mark-slack-fda-de-novo-advice-versius-surgical-robot/">A surgical robotics co-founder offers lessons from the de novo pathway</a> appeared first on <a href="https://www.medicaldesignandoutsourcing.com">Medical Design and Outsourcing</a>.</p> ]]></description> <wfw:commentRss>https://www.medicaldesignandoutsourcing.com/cmr-surgical-mark-slack-fda-de-novo-advice-versius-surgical-robot/feed/</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>Boston Micro Fabrication opens lab for Zirconia UltraThineer Veneers</title> <link>https://www.medicaldesignandoutsourcing.com/boston-micro-fabrication-opens-lab-for-zirconia-ultrathineer-veneers/</link> <comments>https://www.medicaldesignandoutsourcing.com/boston-micro-fabrication-opens-lab-for-zirconia-ultrathineer-veneers/#respond</comments> <dc:creator><![CDATA[MDO Staff]]></dc:creator> <pubDate>Tue, 19 Nov 2024 19:44:34 +0000</pubDate> <category><![CDATA[Dental]]></category> <category><![CDATA[Manufacturing]]></category> <category><![CDATA[News]]></category> <category><![CDATA[Boston Micro Fabrication]]></category> <guid isPermaLink="false">https://www.medicaldesignandoutsourcing.com/?p=274173</guid> <description><![CDATA[<p>NEWS RELEASE: Boston Micro Fabrication Opens Lab to Support Testing, Manufacturing and Sales of Zirconia UltraThineer Veneers Expanded service enables dentists to more easily offer world’s thinnest cosmetic dental veneers across the United States Maynard, Massachusetts — Boston Micro Fabrication (BMF), a leader in advanced manufacturing solutions for ultra-high precision applications, today opened the UltraThineer™…</p> <p>The post <a href="https://www.medicaldesignandoutsourcing.com/boston-micro-fabrication-opens-lab-for-zirconia-ultrathineer-veneers/">Boston Micro Fabrication opens lab for Zirconia UltraThineer Veneers</a> appeared first on <a href="https://www.medicaldesignandoutsourcing.com">Medical Design and Outsourcing</a>.</p> ]]></description> <wfw:commentRss>https://www.medicaldesignandoutsourcing.com/boston-micro-fabrication-opens-lab-for-zirconia-ultrathineer-veneers/feed/</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>Medtronic CEO Geoff Martha talks Trump import taxes and supply chain</title> <link>https://www.medicaldesignandoutsourcing.com/medtronic-ceo-geoff-martha-trump-import-taxes-tariffs-supply-chain/</link> <comments>https://www.medicaldesignandoutsourcing.com/medtronic-ceo-geoff-martha-trump-import-taxes-tariffs-supply-chain/#respond</comments> <dc:creator><![CDATA[Jim Hammerand]]></dc:creator> <pubDate>Tue, 19 Nov 2024 17:25:06 +0000</pubDate> <category><![CDATA[Manufacturing]]></category> <category><![CDATA[News]]></category> <category><![CDATA[Original Equipment Manufacturing (OEM)]]></category> <category><![CDATA[imports]]></category> <category><![CDATA[medtronic]]></category> <category><![CDATA[tariffs]]></category> <category><![CDATA[taxes]]></category> <guid isPermaLink="false">https://www.medicaldesignandoutsourcing.com/?p=274166</guid> <description><![CDATA[<p>Medtronic — the world’s largest medical device company — is preparing for the impact of new import taxes and other policy changes under President-elect Donald Trump, CEO and Chair Geoff Martha said today. While he cautioned that “it’s still a bit early to speculate about different policies, whether it be health care policy or exactly…</p> <p>The post <a href="https://www.medicaldesignandoutsourcing.com/medtronic-ceo-geoff-martha-trump-import-taxes-tariffs-supply-chain/">Medtronic CEO Geoff Martha talks Trump import taxes and supply chain</a> appeared first on <a href="https://www.medicaldesignandoutsourcing.com">Medical Design and Outsourcing</a>.</p> ]]></description> <wfw:commentRss>https://www.medicaldesignandoutsourcing.com/medtronic-ceo-geoff-martha-trump-import-taxes-tariffs-supply-chain/feed/</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>A new standard to address growing cyber threats to medical devices</title> <link>https://www.medicaldesignandoutsourcing.com/a-new-standard-to-address-growing-cyber-threats-to-medical-devices/</link> <comments>https://www.medicaldesignandoutsourcing.com/a-new-standard-to-address-growing-cyber-threats-to-medical-devices/#respond</comments> <dc:creator><![CDATA[MDO Staff]]></dc:creator> <pubDate>Tue, 19 Nov 2024 00:02:18 +0000</pubDate> <category><![CDATA[Cybersecurity]]></category> <category><![CDATA[News]]></category> <category><![CDATA[Standards]]></category> <category><![CDATA[ibm]]></category> <category><![CDATA[IEEE Standards Association]]></category> <guid isPermaLink="false">https://www.medicaldesignandoutsourcing.com/?p=274159</guid> <description><![CDATA[<p>The former CTO of IBM explains IEEE 2933, a new healthcare cybersecurity standard from the IEEE Standards Association. By Florence Hudson, IEEE SA The rapid integration of Internet of Things (IoT) and artificial intelligence (AI) technology into medical devices has revolutionized healthcare, enabling seamless communication between devices and improving patient care. However, this ongoing digital…</p> <p>The post <a href="https://www.medicaldesignandoutsourcing.com/a-new-standard-to-address-growing-cyber-threats-to-medical-devices/">A new standard to address growing cyber threats to medical devices</a> appeared first on <a href="https://www.medicaldesignandoutsourcing.com">Medical Design and Outsourcing</a>.</p> ]]></description> <wfw:commentRss>https://www.medicaldesignandoutsourcing.com/a-new-standard-to-address-growing-cyber-threats-to-medical-devices/feed/</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>Jupiter Endovascular may have solved a critical catheter challenge</title> <link>https://www.medicaldesignandoutsourcing.com/jupiter-endovascular-vertex-pe-catheter-challenge-stiffness-flexibility/</link> <comments>https://www.medicaldesignandoutsourcing.com/jupiter-endovascular-vertex-pe-catheter-challenge-stiffness-flexibility/#respond</comments> <dc:creator><![CDATA[Jim Hammerand]]></dc:creator> <pubDate>Mon, 18 Nov 2024 17:56:25 +0000</pubDate> <category><![CDATA[Catheters]]></category> <category><![CDATA[Clinical Trials]]></category> <category><![CDATA[Devices]]></category> <category><![CDATA[Innovation]]></category> <category><![CDATA[Interventional cardiology]]></category> <category><![CDATA[Metals]]></category> <category><![CDATA[News]]></category> <category><![CDATA[Polymers]]></category> <category><![CDATA[Jupiter Endovascular]]></category> <category><![CDATA[minimally invasive]]></category> <category><![CDATA[Neptune Medical]]></category> <category><![CDATA[pulmonary embolectomy]]></category> <category><![CDATA[pulmonary embolism]]></category> <category><![CDATA[stainless]]></category> <guid isPermaLink="false">https://www.medicaldesignandoutsourcing.com/?p=274148</guid> <description><![CDATA[<p>Balancing catheter flexibility and stiffness has long vexed device designers and engineers trying to access the human anatomy’s innermost reaches. The solution might be a promising new technology originally developed for endoscopy at Neptune Medical, founded by Alex Tilson in 2014. His first hire was Garret Gomes, who’s now VP of product development at Jupiter…</p> <p>The post <a href="https://www.medicaldesignandoutsourcing.com/jupiter-endovascular-vertex-pe-catheter-challenge-stiffness-flexibility/">Jupiter Endovascular may have solved a critical catheter challenge</a> appeared first on <a href="https://www.medicaldesignandoutsourcing.com">Medical Design and Outsourcing</a>.</p> ]]></description> <wfw:commentRss>https://www.medicaldesignandoutsourcing.com/jupiter-endovascular-vertex-pe-catheter-challenge-stiffness-flexibility/feed/</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>Westpak opens device testing facility near San Jose</title> <link>https://www.medicaldesignandoutsourcing.com/westpak-device-packaging-testing-facility-union-city-california/</link> <dc:creator><![CDATA[MDO Staff]]></dc:creator> <pubDate>Fri, 15 Nov 2024 00:20:13 +0000</pubDate> <category><![CDATA[Corporate Expansion]]></category> <category><![CDATA[Laboratory]]></category> <category><![CDATA[News]]></category> <category><![CDATA[Packaging]]></category> <category><![CDATA[Test & Measurement]]></category> <category><![CDATA[Westpak]]></category> <guid isPermaLink="false">https://www.medicaldesignandoutsourcing.com/?p=274115</guid> <description><![CDATA[<p>NEWS RELEASE: New Testing Facility Opens to Improve Product Safety and Deliverability WESTPAK’s new laboratory in Union City, CA, expands capacity and testing capabilities San Jose, CA – WESTPAK, Inc., a leading 3rd-party laboratory providing trusted testing solutions for the medical device, pharmaceutical, and high-tech industries, officially opens its new state-of-the-art laboratory in Union City,…</p> <p>The post <a href="https://www.medicaldesignandoutsourcing.com/westpak-device-packaging-testing-facility-union-city-california/">Westpak opens device testing facility near San Jose</a> appeared first on <a href="https://www.medicaldesignandoutsourcing.com">Medical Design and Outsourcing</a>.</p> ]]></description> </item> <item> <title>Polymer Medical announces ISO 13485 certification</title> <link>https://www.medicaldesignandoutsourcing.com/polymer-medical-iso-13485-qms-device-manufacturing/</link> <dc:creator><![CDATA[MDO Staff]]></dc:creator> <pubDate>Thu, 14 Nov 2024 22:42:31 +0000</pubDate> <category><![CDATA[Certification]]></category> <category><![CDATA[News]]></category> <category><![CDATA[Quality]]></category> <category><![CDATA[Polymer Medical]]></category> <guid isPermaLink="false">https://www.medicaldesignandoutsourcing.com/?p=274108</guid> <description><![CDATA[<p>NEWS RELEASE: Polymer Medical Earns ISO 13485 Medical Devices Quality Management Systems Certification ORCHARD PARK, N.Y. – Polymer Medical has achieved ISO 13485:2016 certification from NSF-ISR, an NSF company, distinguishing its quality management system, or QMS, for manufacturing medical devices. ISO 13485 is the standard for QMS in the medical device industry. “Many of our products directly touch…</p> <p>The post <a href="https://www.medicaldesignandoutsourcing.com/polymer-medical-iso-13485-qms-device-manufacturing/">Polymer Medical announces ISO 13485 certification</a> appeared first on <a href="https://www.medicaldesignandoutsourcing.com">Medical Design and Outsourcing</a>.</p> ]]></description> </item> <item> <title>Researchers develop new coating to make medical devices safer</title> <link>https://www.medicaldesignandoutsourcing.com/ubc-researchers-coating-medical-devices-safer/</link> <dc:creator><![CDATA[Sean Whooley]]></dc:creator> <pubDate>Thu, 14 Nov 2024 20:55:21 +0000</pubDate> <category><![CDATA[Applications]]></category> <category><![CDATA[Coatings]]></category> <category><![CDATA[Implantables]]></category> <category><![CDATA[Medical]]></category> <category><![CDATA[Medical Tubing & Extrusion]]></category> <category><![CDATA[Research]]></category> <category><![CDATA[Research & Development]]></category> <category><![CDATA[Tubing]]></category> <category><![CDATA[University of British Columbia]]></category> <category><![CDATA[universityofbritishcolumbia]]></category> <guid isPermaLink="false">https://www.medicaldesignandoutsourcing.com/?p=274105</guid> <description><![CDATA[<p>Researchers at The University of British Columbia (UBC) say they developed a new coating that could reduce risks associated with some medical devices. The researchers designed the material to mimic the natural behavior of blood vessels to allow for the safer use of blood-contacting devices. Those include catheters, stents, blood-oxygenation machines and dialysis machines. According…</p> <p>The post <a href="https://www.medicaldesignandoutsourcing.com/ubc-researchers-coating-medical-devices-safer/">Researchers develop new coating to make medical devices safer</a> appeared first on <a href="https://www.medicaldesignandoutsourcing.com">Medical Design and Outsourcing</a>.</p> ]]></description> </item> <item> <title>CDC taps Alveo for bird flu test development as H5N1 spreads</title> <link>https://www.medicaldesignandoutsourcing.com/cdc-h5n1-bird-flu-test-avian-influenza-development-alveo-ah5/</link> <dc:creator><![CDATA[Jim Hammerand]]></dc:creator> <pubDate>Thu, 14 Nov 2024 13:00:37 +0000</pubDate> <category><![CDATA[Diagnostics]]></category> <category><![CDATA[News]]></category> <category><![CDATA[Product Development]]></category> <category><![CDATA[Alveo Technologies]]></category> <category><![CDATA[avian flu]]></category> <category><![CDATA[bird flu]]></category> <category><![CDATA[CDC]]></category> <category><![CDATA[h5n1]]></category> <category><![CDATA[influenza]]></category> <guid isPermaLink="false">https://www.medicaldesignandoutsourcing.com/?p=274100</guid> <description><![CDATA[<p>Alveo Technologies has a deal with the CDC to develop a portable influenza test that detects and differentiates between the bird flu A(H5) virus and seasonal flu subtypes. Such a test would enable physicians to quickly identify and report patients with A(H5) infections as the avian flu spreads across North American bird populations, dairy cows…</p> <p>The post <a href="https://www.medicaldesignandoutsourcing.com/cdc-h5n1-bird-flu-test-avian-influenza-development-alveo-ah5/">CDC taps Alveo for bird flu test development as H5N1 spreads</a> appeared first on <a href="https://www.medicaldesignandoutsourcing.com">Medical Design and Outsourcing</a>.</p> ]]></description> </item> <item> <title>Resonetics VP Eric Veit on medical nitinol lead times, prices and ‘major changes’ in the works</title> <link>https://www.medicaldesignandoutsourcing.com/resonetics-nitinol-lead-times-prices-devices-components/</link> <dc:creator><![CDATA[Jim Hammerand]]></dc:creator> <pubDate>Wed, 13 Nov 2024 21:21:08 +0000</pubDate> <category><![CDATA[Components]]></category> <category><![CDATA[Contract Manufacturing]]></category> <category><![CDATA[Materials]]></category> <category><![CDATA[Metals]]></category> <category><![CDATA[News]]></category> <category><![CDATA[Prototyping]]></category> <category><![CDATA[Tubing]]></category> <category><![CDATA[Tubing Components]]></category> <category><![CDATA[Confluent Medical Technologies]]></category> <category><![CDATA[nitinol]]></category> <category><![CDATA[Resonetics]]></category> <guid isPermaLink="false">https://www.medicaldesignandoutsourcing.com/?p=274073</guid> <description><![CDATA[<p>To help medical device developers and manufacturers take full advantage of the unique properties of nitinol for cardiovascular devices, surgical robotics and other minimally invasive technologies, Medical Design & Outsourcing is diving deep into the supply chain with leading nitinol suppliers. Our latest interview is with Resonetics Nitinol Business Development VP Eric Veit, who discussed…</p> <p>The post <a href="https://www.medicaldesignandoutsourcing.com/resonetics-nitinol-lead-times-prices-devices-components/">Resonetics VP Eric Veit on medical nitinol lead times, prices and ‘major changes’ in the works</a> appeared first on <a href="https://www.medicaldesignandoutsourcing.com">Medical Design and Outsourcing</a>.</p> ]]></description> </item> <item> <title>November 2024 edition: The Medical Device Handbook</title> <link>https://www.medicaldesignandoutsourcing.com/november-2024-edition-medical-device-handbook/</link> <dc:creator><![CDATA[Jim Hammerand]]></dc:creator> <pubDate>Wed, 13 Nov 2024 18:09:20 +0000</pubDate> <category><![CDATA[Digital Editions]]></category> <category><![CDATA[Handbooks]]></category> <category><![CDATA[Medical Device Business]]></category> <category><![CDATA[Boston Scientific]]></category> <guid isPermaLink="false">https://www.medicaldesignandoutsourcing.com/?p=274063</guid> <description><![CDATA[<p> Medtech expertise you can trust in the 2024 Medical Device Handbook It’s never easy in medtech. Device design, development and manufacturing is hard enough even without the industry’s new laws and regulations, supply chain shocks and economic challenges. We’re here to help with the 2024 Medical Design & Outsourcing Medical Device Handbook. It’s the…</p> <p>The post <a href="https://www.medicaldesignandoutsourcing.com/november-2024-edition-medical-device-handbook/">November 2024 edition: The Medical Device Handbook</a> appeared first on <a href="https://www.medicaldesignandoutsourcing.com">Medical Design and Outsourcing</a>.</p> ]]></description> </item> <item> <title>Steris discloses hundreds of ethylene oxide lawsuits over device sterilization plant</title> <link>https://www.medicaldesignandoutsourcing.com/steris-ethylene-oxide-eto-lawsuits-isomedix-waukegan-illinois/</link> <dc:creator><![CDATA[Jim Hammerand]]></dc:creator> <pubDate>Tue, 12 Nov 2024 22:51:44 +0000</pubDate> <category><![CDATA[Medical Device Business]]></category> <category><![CDATA[News]]></category> <category><![CDATA[Regulatory]]></category> <category><![CDATA[Sterilization]]></category> <category><![CDATA[ethylene oxide]]></category> <category><![CDATA[ethylene oxide sterilization]]></category> <category><![CDATA[eto]]></category> <category><![CDATA[steris]]></category> <guid isPermaLink="false">https://www.medicaldesignandoutsourcing.com/?p=274060</guid> <description><![CDATA[<p>Steris faces hundreds of lawsuits alleging harm from emissions of ethylene oxide (EtO) used to sterilize medical devices. The medical device company — which provides contract sterilization for medical device manufacturers through its Applied Sterilization Technologies (AST) unit and makes sterile products for hospitals — disclosed the pending litigation last week. Around 275 people have…</p> <p>The post <a href="https://www.medicaldesignandoutsourcing.com/steris-ethylene-oxide-eto-lawsuits-isomedix-waukegan-illinois/">Steris discloses hundreds of ethylene oxide lawsuits over device sterilization plant</a> appeared first on <a href="https://www.medicaldesignandoutsourcing.com">Medical Design and Outsourcing</a>.</p> ]]></description> </item> <item> <title>Three strategies for unlocking the power of continuous integration/continuous deployment (CI/CD) for AI-powered medical devices</title> <link>https://www.medicaldesignandoutsourcing.com/continuous-integration-continuous-deployment-ci-cd-strategies-ai-ml-devices/</link> <dc:creator><![CDATA[MDO Contributors Network]]></dc:creator> <pubDate>Tue, 12 Nov 2024 17:30:03 +0000</pubDate> <category><![CDATA[Artificial intelligence]]></category> <category><![CDATA[Machine learning]]></category> <category><![CDATA[News]]></category> <category><![CDATA[Product Development]]></category> <category><![CDATA[Quality]]></category> <category><![CDATA[Software]]></category> <category><![CDATA[artificial intelligence]]></category> <category><![CDATA[Ketryx]]></category> <category><![CDATA[machine learning]]></category> <category><![CDATA[SaMD]]></category> <category><![CDATA[software as a medical device (SaMD)]]></category> <guid isPermaLink="false">https://www.medicaldesignandoutsourcing.com/?p=274052</guid> <description><![CDATA[<p>Continuous integration and deployment is essential for successful development of devices enabled by artificial intelligence and machine learning. By Erez Kaminski, Ketryx It’s no secret that AI-powered medical devices are revolutionizing healthcare, setting new standards for speed, precision, and accuracy in the diagnostics that drive better patient outcomes. Artificial intelligence (AI) and machine learning (ML)…</p> <p>The post <a href="https://www.medicaldesignandoutsourcing.com/continuous-integration-continuous-deployment-ci-cd-strategies-ai-ml-devices/">Three strategies for unlocking the power of continuous integration/continuous deployment (CI/CD) for AI-powered medical devices</a> appeared first on <a href="https://www.medicaldesignandoutsourcing.com">Medical Design and Outsourcing</a>.</p> ]]></description> </item> </channel> </rss>