{"id":1307,"date":"2026-11-09T11:13:54","date_gmt":"2026-11-09T12:13:54","guid":{"rendered":"https:\/\/pechealthcare.com\/news-and-events\/"},"modified":"2026-11-09T12:12:38","modified_gmt":"2026-11-09T13:12:38","slug":"news-and-events","status":"publish","type":"page","link":"https:\/\/pechealthcare.com\/news-and-events\/","title":{"rendered":"News and events"},"content":{"rendered":"<style>#pn{width:min(1240px,94vw);max-width:none;margin:0 0 0 calc(50% - min(1240px,94vw)\/2);padding:10px 0 40px;font-family:inherit}#pn .pn-imgw{position:relative}#pn .pn-credit{position:absolute;left:8px;bottom:8px;z-index:4;max-width:calc(100% - 16px);font-size:10.5px;line-height:1.3;color:#fff;background:rgba(0,0,0,.55);padding:2px 8px;border-radius:4px;text-decoration:none;opacity:.85}#pn .pn-credit:hover{opacity:1;color:#fff}#pn .pn-intro{max-width:720px;color:#5b6770;margin:0 0 24px;font-size:16px;line-height:1.6}#pn .pn-f{display:flex;flex-wrap:wrap;gap:8px;margin:0 0 28px}#pn .pn-f button{border:1px solid #d5dde2;background:#fff;color:#33424d;border-radius:999px;padding:8px 18px;font-size:14px;cursor:pointer}#pn .pn-f button.on{background:#1fb5a8;border-color:#1fb5a8;color:#fff}#pn .pn-grid{display:grid;grid-template-columns:repeat(3,1fr);gap:24px;padding:6px}#pn .pn-card{position:relative;background:#fff;border:1px solid #e3e9ed;border-radius:12px;overflow:hidden;display:flex;flex-direction:column;box-shadow:0 1px 3px rgba(20,40,50,.05);transition:transform .25s ease,box-shadow .25s ease;will-change:transform}#pn .pn-card:hover,#pn .pn-card:focus-within{transform:scale(1.035);box-shadow:0 16px 34px rgba(20,40,50,.16);z-index:3}#pn .pn-imgw{aspect-ratio:16\/9;overflow:hidden;background:#e8f1f4}#pn .pn-img{width:100%;height:100%;object-fit:cover;display:block;margin:0;max-width:none}#pn .pn-body{padding:20px 22px 22px;display:flex;flex-direction:column;flex:1}#pn .pn-top{grid-column:1\/-1;display:grid;grid-template-columns:1.1fr 1fr;background:#f3fbfa;border-color:#bfe8e3}#pn .pn-top .pn-imgw{aspect-ratio:auto;min-height:260px}#pn .pn-top:hover,#pn .pn-top:focus-within{transform:scale(1.015)}#pn .pn-top .pn-body{padding:30px;justify-content:center}#pn .pn-top h3{font-size:24px}#pn .pn-meta{display:flex;gap:8px;align-items:center;margin-bottom:12px}#pn .pn-tag{color:#fff;font-size:11px;letter-spacing:.06em;text-transform:uppercase;border-radius:4px;padding:3px 9px;font-weight:600}#pn .pn-badge{font-size:11px;letter-spacing:.06em;text-transform:uppercase;color:#1a8f85;font-weight:600}#pn h3{font-size:17px;line-height:1.35;margin:0 0 10px;text-transform:none;font-weight:600;letter-spacing:0}#pn h3 a{color:#14232c;text-decoration:none}#pn h3 a:hover{color:#1a8f85}#pn h3 a:after{content:\"\";position:absolute;left:0;top:0;right:0;bottom:0;z-index:1}#pn .pn-ex{color:#53616b;font-size:15px;line-height:1.55;margin:0 0 14px}#pn .pn-foot{display:flex;flex-wrap:wrap;gap:6px 14px;font-size:12.5px;color:#7a8791;margin-top:auto;padding-top:10px}#pn .pn-more{margin-top:12px;font-weight:600;color:#1a8f85;text-decoration:none;font-size:14px}#pn .pn-cta{margin-top:40px;background:#14232c;color:#fff;border-radius:12px;padding:30px;text-align:center}#pn .pn-cta h3{color:#fff;margin:0 0 8px;font-size:20px}#pn .pn-cta p{color:#c5d2d9;margin:0 0 16px}#pn .pn-cta a{display:inline-block;background:#1fb5a8;color:#fff;border-radius:6px;padding:11px 24px;text-decoration:none;font-weight:600}@media(max-width:900px){#pn .pn-grid{grid-template-columns:repeat(2,1fr)}#pn .pn-top{grid-template-columns:1fr}#pn .pn-top .pn-imgw{aspect-ratio:16\/9;min-height:0}}@media(max-width:600px){#pn .pn-grid{grid-template-columns:1fr}#pn .pn-top h3{font-size:21px}}@media(prefers-reduced-motion:reduce){#pn .pn-card{transition:none}#pn .pn-card:hover,#pn .pn-card:focus-within{transform:none}}#pn .pn-cta p,#pn .pn-cta h3{color:#fff!important}#pn .pn-cta p{opacity:1}#pn{direction:ltr}<\/style>\n<div id=\"pn\">\n<p class=\"pn-intro\">Regulation, safety alerts, standards and technology from the world of anesthesia, infusion and respiratory equipment, including how artificial intelligence is changing medical devices. Each story is summarised in plain language with a link to the original source.<\/p>\n<div class=\"pn-f\"><button class=\"on\" data-c=\"all\">All news<\/button><button data-c=\"6\">Regulatory<\/button><button data-c=\"7\">Safety Alert<\/button><button data-c=\"8\">Technology<\/button><button data-c=\"9\">Market<\/button><\/div>\n<div class=\"pn-grid\">\n<article class=\"pn-card pn-top\" data-c=\"8\">\n<div class=\"pn-imgw\"><img decoding=\"async\" class=\"pn-img\" loading=\"lazy\" alt=\"Close-up of a microchip die under magnification\" src=\"https:\/\/pechealthcare.com\/wp-content\/uploads\/2026\/11\/pec-news-chip.jpg\" style=\"object-position:center 50%\"><span class=\"pn-credit\">Photo: FritzchensFritz (CC0)<\/span><\/div>\n<div class=\"pn-body\">\n<div class=\"pn-meta\"><span class=\"pn-tag\" style=\"background:#0d9aa8\">Technology<\/span><span class=\"pn-badge\">Top story<\/span><\/div>\n<h3><a href=\"https:\/\/pechealthcare.com\/one-third-of-fda-cleared-ai-devices-received-algorithm-updates-most-without-reported-clinical-benefit\/\">One-Third of FDA-Cleared AI Devices Received Algorithm Updates, Most Without Reported Clinical Benefit<\/a><\/h3>\n<p class=\"pn-ex\">A JAMA Network Open research letter reviewed 163 AI devices cleared between 2015 and 2021 and found that most updates reported no clinical or organizational benefit.<\/p>\n<div class=\"pn-foot\"><span>November 7, 2026<\/span><span>2 min read<\/span><span>Medical Daily, reporting on JAMA Network Open<\/span><\/div>\n<p><a class=\"pn-more\" href=\"https:\/\/pechealthcare.com\/one-third-of-fda-cleared-ai-devices-received-algorithm-updates-most-without-reported-clinical-benefit\/\">Read the summary &rarr;<\/a><\/div>\n<\/article>\n<article class=\"pn-card\" data-c=\"6\">\n<div class=\"pn-imgw\"><img decoding=\"async\" class=\"pn-img\" loading=\"lazy\" alt=\"Modern FDA office building against a blue sky\" src=\"https:\/\/pechealthcare.com\/wp-content\/uploads\/2026\/11\/pec-news-gen.jpg\" style=\"object-position:center 55%\"><span class=\"pn-credit\">Photo: The U.S. Food and Drug Administration (Public domain)<\/span><\/div>\n<div class=\"pn-body\">\n<div class=\"pn-meta\"><span class=\"pn-tag\" style=\"background:#6d5bd0\">Regulatory<\/span><\/div>\n<h3><a href=\"https:\/\/pechealthcare.com\/industry-and-clinicians-split-on-how-fda-should-regulate-generative-ai-in-medical-devices\/\">Industry and Clinicians Split on How FDA Should Regulate Generative AI in Medical Devices<\/a><\/h3>\n<p class=\"pn-ex\">More than 500 comments reached the FDA on its August discussion paper. Manufacturers want to build on current rules; patient and physician groups want stronger postmarket monitoring.<\/p>\n<div class=\"pn-foot\"><span>November 3, 2026<\/span><span>2 min read<\/span><span>Healthcare Dive<\/span><\/div>\n<p><a class=\"pn-more\" href=\"https:\/\/pechealthcare.com\/industry-and-clinicians-split-on-how-fda-should-regulate-generative-ai-in-medical-devices\/\">Read the summary &rarr;<\/a><\/div>\n<\/article>\n<article class=\"pn-card\" data-c=\"7\">\n<div class=\"pn-imgw\"><img decoding=\"async\" class=\"pn-img\" loading=\"lazy\" alt=\"Clinician loading an infusion set into a modular infusion pump\" src=\"https:\/\/pechealthcare.com\/wp-content\/uploads\/2026\/11\/pec-news-alaris.jpg\" style=\"object-position:center 42%\"><span class=\"pn-credit\">Photo: Senior Airman Andrea Posey\/U.S. Air Force (Public domain)<\/span><\/div>\n<div class=\"pn-body\">\n<div class=\"pn-meta\"><span class=\"pn-tag\" style=\"background:#d64545\">Safety Alert<\/span><\/div>\n<h3><a href=\"https:\/\/pechealthcare.com\/bd-alaris-infusion-sets-removed-after-flow-accuracy-was-found-overestimated-at-low-rates\/\">BD Alaris Infusion Sets Removed After Flow Accuracy Was Found Overestimated at Low Rates<\/a><\/h3>\n<p class=\"pn-ex\">Certain sets used with the Alaris Pump Module 8100 may deviate from programmed flow below 1 mL\/h and at small bolus volumes, with delayed occlusion alarms.<\/p>\n<div class=\"pn-foot\"><span>October 14, 2026<\/span><span>2 min read<\/span><span>U.S. Food and Drug Administration<\/span><\/div>\n<p><a class=\"pn-more\" href=\"https:\/\/pechealthcare.com\/bd-alaris-infusion-sets-removed-after-flow-accuracy-was-found-overestimated-at-low-rates\/\">Read the summary &rarr;<\/a><\/div>\n<\/article>\n<article class=\"pn-card\" data-c=\"8\">\n<div class=\"pn-imgw\"><img decoding=\"async\" class=\"pn-img\" loading=\"lazy\" alt=\"Volumetric infusion pump with display and keypad\" src=\"https:\/\/pechealthcare.com\/wp-content\/uploads\/2026\/11\/pec-news-aipump.jpg\" style=\"object-position:center 38%\"><a class=\"pn-credit\" href=\"https:\/\/commons.wikimedia.org\/wiki\/File:Baxter_Colleague_CX_infusion_pump.JPG\" target=\"_blank\" rel=\"noopener noreferrer\">Photo: BrokenSphere (CC BY-SA 3.0)<\/a><\/div>\n<div class=\"pn-body\">\n<div class=\"pn-meta\"><span class=\"pn-tag\" style=\"background:#0d9aa8\">Technology<\/span><\/div>\n<h3><a href=\"https:\/\/pechealthcare.com\/review-ai-in-iv-infusion-systems-is-still-mostly-at-the-prototype-stage\/\">Review: AI in IV Infusion Systems Is Still Mostly at the Prototype Stage<\/a><\/h3>\n<p class=\"pn-ex\">A new review in npj Digital Medicine finds that closed-loop control is rare, interoperability is weak and data security is inconsistent in AI-enabled infusion systems.<\/p>\n<div class=\"pn-foot\"><span>October 14, 2026<\/span><span>2 min read<\/span><span>npj Digital Medicine (Nature Portfolio)<\/span><\/div>\n<p><a class=\"pn-more\" href=\"https:\/\/pechealthcare.com\/review-ai-in-iv-infusion-systems-is-still-mostly-at-the-prototype-stage\/\">Read the summary &rarr;<\/a><\/div>\n<\/article>\n<article class=\"pn-card\" data-c=\"9\">\n<div class=\"pn-imgw\"><img decoding=\"async\" class=\"pn-img\" loading=\"lazy\" alt=\"Stack of syringe pumps mounted on a pole in a hospital\" src=\"https:\/\/pechealthcare.com\/wp-content\/uploads\/2026\/11\/pec-news-market.jpg\" style=\"object-position:center 28%\"><span class=\"pn-credit\">Photo: Stefan Bellini (CC0)<\/span><\/div>\n<div class=\"pn-body\">\n<div class=\"pn-meta\"><span class=\"pn-tag\" style=\"background:#d9882a\">Market<\/span><\/div>\n<h3><a href=\"https:\/\/pechealthcare.com\/infusion-pump-market-estimated-at-usd-14-87-billion-in-2026-with-smart-and-connected-pumps-driving-growth\/\">Infusion Pump Market Estimated at USD 14.87 Billion in 2026, With Smart and Connected Pumps Driving Growth<\/a><\/h3>\n<p class=\"pn-ex\">A Research and Markets report projects the market to reach USD 25.39 billion by 2035, with AI, IoT connectivity and EHR integration cited as growth drivers.<\/p>\n<div class=\"pn-foot\"><span>September 7, 2026<\/span><span>2 min read<\/span><span>GlobeNewswire (Research and Markets)<\/span><\/div>\n<p><a class=\"pn-more\" href=\"https:\/\/pechealthcare.com\/infusion-pump-market-estimated-at-usd-14-87-billion-in-2026-with-smart-and-connected-pumps-driving-growth\/\">Read the summary &rarr;<\/a><\/div>\n<\/article>\n<article class=\"pn-card\" data-c=\"6\">\n<div class=\"pn-imgw\"><img decoding=\"async\" class=\"pn-img\" loading=\"lazy\" alt=\"European Commission Berlaymont building in Brussels with an EU flag\" src=\"https:\/\/pechealthcare.com\/wp-content\/uploads\/2026\/11\/pec-news-eu.jpg\" style=\"object-position:center 45%\"><span class=\"pn-credit\">Photo: almathias (CC0)<\/span><\/div>\n<div class=\"pn-body\">\n<div class=\"pn-meta\"><span class=\"pn-tag\" style=\"background:#6d5bd0\">Regulatory<\/span><\/div>\n<h3><a href=\"https:\/\/pechealthcare.com\/eu-ai-act-high-risk-deadline-for-ai-embedded-in-medical-devices-moves-to-august-2028\/\">EU AI Act: High-Risk Deadline for AI Embedded in Medical Devices Moves to August 2028<\/a><\/h3>\n<p class=\"pn-ex\">Under the Digital Omnibus agreement, AI built into regulated products such as medical devices gets an extra year, while the risk tiers and obligations stay the same.<\/p>\n<div class=\"pn-foot\"><span>July 4, 2026<\/span><span>2 min read<\/span><span>Reading the Evidence<\/span><\/div>\n<p><a class=\"pn-more\" href=\"https:\/\/pechealthcare.com\/eu-ai-act-high-risk-deadline-for-ai-embedded-in-medical-devices-moves-to-august-2028\/\">Read the summary &rarr;<\/a><\/div>\n<\/article>\n<article class=\"pn-card\" data-c=\"7\">\n<div class=\"pn-imgw\"><img decoding=\"async\" class=\"pn-img\" loading=\"lazy\" alt=\"Operating room with an anesthesia machine beside the operating table\" src=\"https:\/\/pechealthcare.com\/wp-content\/uploads\/2026\/11\/pec-news-atlan-1.jpg\" style=\"object-position:center 60%\"><a class=\"pn-credit\" href=\"https:\/\/commons.wikimedia.org\/wiki\/File:Operating_room_anesthetic_station.jpg\" target=\"_blank\" rel=\"noopener noreferrer\">Photo: Coronation Dental Specialty Group (CC BY-SA 3.0)<\/a><\/div>\n<div class=\"pn-body\">\n<div class=\"pn-meta\"><span class=\"pn-tag\" style=\"background:#d64545\">Safety Alert<\/span><\/div>\n<h3><a href=\"https:\/\/pechealthcare.com\/fda-classifies-drager-atlan-a350-anesthesia-machine-correction-as-class-i\/\">FDA Classifies Dr\u00e4ger Atlan A350 Anesthesia Machine Correction as Class I<\/a><\/h3>\n<p class=\"pn-ex\">A manufacturing error may cause the piston ventilator in Atlan A350 and A350 XL machines to fail before or during a procedure. Dr\u00e4ger is replacing the ventilator motor assembly.<\/p>\n<div class=\"pn-foot\"><span>June 15, 2026<\/span><span>2 min read<\/span><span>U.S. Food and Drug Administration<\/span><\/div>\n<p><a class=\"pn-more\" href=\"https:\/\/pechealthcare.com\/fda-classifies-drager-atlan-a350-anesthesia-machine-correction-as-class-i\/\">Read the summary &rarr;<\/a><\/div>\n<\/article>\n<article class=\"pn-card\" data-c=\"7\">\n<div class=\"pn-imgw\"><img decoding=\"async\" class=\"pn-img\" loading=\"lazy\" alt=\"Anesthesia machine with breathing circuit and monitors in an operating theatre\" src=\"https:\/\/pechealthcare.com\/wp-content\/uploads\/2026\/11\/pec-news-care-1.jpg\" style=\"object-position:center 55%\"><a class=\"pn-credit\" href=\"https:\/\/commons.wikimedia.org\/wiki\/File:Maquet_Flow-I_anesthesia_machine.jpg\" target=\"_blank\" rel=\"noopener noreferrer\">Photo: DiverDave (CC BY-SA 3.0)<\/a><\/div>\n<div class=\"pn-body\">\n<div class=\"pn-meta\"><span class=\"pn-tag\" style=\"background:#d64545\">Safety Alert<\/span><\/div>\n<h3><a href=\"https:\/\/pechealthcare.com\/ge-healthcare-corrects-carestation-anesthesia-systems-at-risk-of-ineffective-ventilation-in-volume-control-mode\/\">GE HealthCare Corrects Carestation Anesthesia Systems at Risk of Ineffective Ventilation in Volume Control Mode<\/a><\/h3>\n<p class=\"pn-ex\">Certain Carestation 620, 650 and 750 series machines may not ventilate effectively in Volume Control Ventilation mode, which could lead to hypoxia.<\/p>\n<div class=\"pn-foot\"><span>June 5, 2026<\/span><span>2 min read<\/span><span>U.S. Food and Drug Administration<\/span><\/div>\n<p><a class=\"pn-more\" href=\"https:\/\/pechealthcare.com\/ge-healthcare-corrects-carestation-anesthesia-systems-at-risk-of-ineffective-ventilation-in-volume-control-mode\/\">Read the summary &rarr;<\/a><\/div>\n<\/article>\n<article class=\"pn-card\" data-c=\"7\">\n<div class=\"pn-imgw\"><img decoding=\"async\" class=\"pn-img\" loading=\"lazy\" alt=\"IV pole with a fluid bag, drip chamber and administration set\" src=\"https:\/\/pechealthcare.com\/wp-content\/uploads\/2026\/11\/pec-news-ivenix.jpg\" style=\"object-position:center 30%\"><a class=\"pn-credit\" href=\"https:\/\/commons.wikimedia.org\/wiki\/File:IV_pole_top_portion.JPG\" target=\"_blank\" rel=\"noopener noreferrer\">Photo: BrokenSphere (CC BY-SA 3.0)<\/a><\/div>\n<div class=\"pn-body\">\n<div class=\"pn-meta\"><span class=\"pn-tag\" style=\"background:#d64545\">Safety Alert<\/span><\/div>\n<h3><a href=\"https:\/\/pechealthcare.com\/fda-assigns-class-i-to-ivenix-infusion-set-recall-after-a-misassembly-defect\/\">FDA Assigns Class I to Ivenix Infusion Set Recall After a Misassembly Defect<\/a><\/h3>\n<p class=\"pn-ex\">A single lot of Ivenix large volume pump administration sets was assembled with the drip chamber and Luer lock reversed, which can cause reverse flow.<\/p>\n<div class=\"pn-foot\"><span>January 5, 2026<\/span><span>2 min read<\/span><span>U.S. Food and Drug Administration<\/span><\/div>\n<p><a class=\"pn-more\" href=\"https:\/\/pechealthcare.com\/fda-assigns-class-i-to-ivenix-infusion-set-recall-after-a-misassembly-defect\/\">Read the summary &rarr;<\/a><\/div>\n<\/article>\n<\/div>\n<div class=\"pn-cta\">\n<h3>Not sure how these changes affect your equipment?<\/h3>\n<p>Tell us what you run and we will tell you what it means for your verification and service plan.<\/p>\n<p><a href=\"\/contact-us\/\">Talk to our team<\/a><\/div>\n<\/div>\n<p><script>(function(){var CATS={\"6\":[\"Regulatory\",\"#6d5bd0\"],\"7\":[\"Safety Alert\",\"#d64545\"],\"8\":[\"Technology\",\"#0d9aa8\"],\"9\":[\"Market\",\"#d9882a\"]};var w=document.getElementById(\"pn\");if(!w){return;}var g=w.querySelector(\".pn-grid\");var bs=w.querySelectorAll(\".pn-f button\");function apply(c){var k=w.querySelectorAll(\".pn-card\");for(var i=0;k.length>i;i++){k[i].style.display=(c===\"all\"||k[i].getAttribute(\"data-c\")===c)?\"\":\"none\";}}function 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Each story is summarised in plain language with a link to the original source. All newsRegulatorySafety AlertTechnologyMarket Photo: FritzchensFritz (CC0) TechnologyTop story One-Third of FDA-Cleared AI Devices Received Algorithm Updates, Most Without [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-1307","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/pechealthcare.com\/api\/wp\/v2\/pages\/1307","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pechealthcare.com\/api\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/pechealthcare.com\/api\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/pechealthcare.com\/api\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/pechealthcare.com\/api\/wp\/v2\/comments?post=1307"}],"version-history":[{"count":10,"href":"https:\/\/pechealthcare.com\/api\/wp\/v2\/pages\/1307\/revisions"}],"predecessor-version":[{"id":1331,"href":"https:\/\/pechealthcare.com\/api\/wp\/v2\/pages\/1307\/revisions\/1331"}],"wp:attachment":[{"href":"https:\/\/pechealthcare.com\/api\/wp\/v2\/media?parent=1307"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}