{"id":7952,"date":"2026-05-19T16:00:00","date_gmt":"2026-05-19T14:00:00","guid":{"rendered":"http:\/\/stocks-future.com\/?guid=666822c0d3d90caf47cbedf45104cc3c"},"modified":"2026-05-19T16:00:00","modified_gmt":"2026-05-19T14:00:00","slug":"intersystems-intellicare-becomes-the-first-ai-native-ehr-to-achieve-eu-medical-device-regulation-certification","status":"publish","type":"post","link":"https:\/\/stocks-future.com\/?p=7952","title":{"rendered":"InterSystems IntelliCare Becomes the First AI-Native EHR to Achieve EU Medical Device Regulation Certification"},"content":{"rendered":"

\nRegulatory milestone reaffirms InterSystems as a leading provider of enterprise-grade AI applications<\/p>

BOSTON--(BUSINESS WIRE)--InterSystems<\/a>, a creative data technology provider powering more than one billion health records globally, today announced that its electronic health record (EHR) solutions have been certified as Class IIa Medical Devices under Regulation (MDR) certification under Regulation (EU) 2017\/745. This approval marks the first fully unified AI-native EHR to achieve MDR Class IIa certification in the European Union.<\/p><\/a><\/a><\/a><\/a>

\nThis certification demonstrates that InterSystems AI-native EHR meets stringent EU safety and quality standards. This key milestone has significant implications for how healthcare organizations can responsibly scale AI while building confidence among healthcare providers and regulators.<\/p>

\nInterSystems has secured MDR certification for InterSystems IntelliCare<\/a>\u2122, a next-generation EHR architected with native artificial intelligence capabilities, and InterSystems TrakCare\u00ae,<\/a> a unified healthcare information system used by leading healthcare systems globally. Built on TrakCare's proven interoperability foundation, InterSystems IntelliCare differentiates itself by delivering AI capabilities that are fundamentally designed into the platform's data layer, rather than bolted on as third-party applications.<\/p>

\n\u201cHealthcare organizations are rightfully demanding that AI be more than just an experimental add-on,\u201d said Don Woodlock, President, InterSystems. \u201cBy securing the EU\u2019s first MDR certification for an AI-native EHR, we are establishing a standard that AI should be at the core of all healthcare applications.\u201d<\/p>

\nBy moving beyond fragmented AI add-ons, InterSystems IntelliCare provides organizations with simplified oversight for their own governance, and clinicians with tools designed to reduce workload and burnout. The platform delivers instant patient summaries, AI\u2011driven clinical documentation, full chat experiences and intelligent workflows that maintain a critical \"human-in-the-loop\" safeguard. Features such as ambient clinical orchestration automatically capture, structure and save clinical data in real-time and suggest clinical documentation and orders for clinician approval. InterSystems IntelliCare also seamlessly connects with existing health IT infrastructures, leveraging InterSystems deep history in integration and data management capabilities.<\/p>

\nAbout InterSystems\n<\/b>InterSystems, a creative data technology provider, delivers a unified foundation for next-generation applications for healthcare, finance, manufacturing, and supply chain customers in more than 80 countries. Our data platforms solve interoperability, speed, and scalability problems for large organizations around the globe to unlock the power of data and allow people to perceive data in imaginative ways. Established in 1978, InterSystems is committed to excellence through its award-winning, 24\u00d77 support for customers and partners around the world. Privately held and headquartered in Boston, Massachusetts, InterSystems has 38 offices in 28 countries worldwide. For more information, please visit InterSystems.com<\/a>.<\/p> Contacts<\/b>

\nInterSystems PR Contact:<\/b>Zach Keating\npr@intersystems.com<\/a>617-551-5158<\/p>","protected":false},"excerpt":{"rendered":"

Regulatory milestone reaffirms InterSystems as a leading provider of enterprise-grade AI applicationsBOSTON–(BUSINESS WIRE)–InterSystems, a creative data technology provider powering more than one billion health records globally, today announced tha…<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-7952","post","type-post","status-publish","format-standard","hentry","category-infos-businesswire"],"_links":{"self":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/7952","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=7952"}],"version-history":[{"count":1,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/7952\/revisions"}],"predecessor-version":[{"id":7953,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/7952\/revisions\/7953"}],"wp:attachment":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=7952"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=7952"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=7952"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}