Association for the Advancement of Medical Instrumentation News Releases

AAMI Surveys Cardiac Health Professionals on Battery Longevity Management of Pacemakers

Tue, 28 Jul 2026 08:50:00 -0400

Arlington, Virginia--(Newsfile Corp. - July 28, 2026) - The Association for the Advancement of Medical Instrumentation (AAMI) officially announces the publication of a new guidance document on battery longevity management for implantable cardiac pacemakers and related devices. Given the limits of existing industry standards for cardiovascular implantable electronic device safety, there is significant variation among devices and in how manufacturers convey longevity information to clinicians.A...

AAMI Updates Standard for Manufacturers of Medtech Steam Sterilization Systems

Tue, 14 Jul 2026 08:55:00 -0400

Arlington, Virginia--(Newsfile Corp. - July 14, 2026) - The Association for the Advancement of Medical Instrumentation (AAMI) today announces the revision to its American National Standard that establishes safety and performance requirements for steam sterilization units used to process reusable medical devices in hospitals and other healthcare delivery organizations. ANSI/AAMI ST8:2026; Hospital steam sterilizers provides minimum labeling, safety, performance, and testing requirements to help...

AAMI Returns to Costa Rica with Advanced QMSR Course for Medical Device Professionals

Thu, 25 Jun 2026 08:50:00 -0400

Arlington, Virginia--(Newsfile Corp. - June 25, 2026) - Building on a partnership launched five years ago to strengthen the region's world-class medical device sector, the Association for the Advancement of Medical Instrumentation (AAMI) is returning to Costa Rica this August with a three-day course on FDA's Quality Management System Regulation."Design and Development - Navigating and Implementing QMSR" will be held from August 25-27, 2026, offering medical device industry professionals...

Food and Drug Administration Adds AAMI Cybersecurity Guidance to Recognized Consensus Standards Database

Tue, 24 Mar 2026 10:06:00 -0400

Arlington, Virginia--(Newsfile Corp. - March 24, 2026) - The Food and Drug Administration (FDA) recently added the Association for the Advancement of Medical Instrumentation's primary guidance document on cybersecurity for artificial intelligence (AI) or machine learning (ML)-enabled medical devices to its database of recognized consensus standards. AAMI CR515:2025; Cybersecurity considerations unique to machine learning-enabled medical devices was released in 2025 to fill existing gaps in...

FDA Leadership Headlines at AAMI neXus 2026 Medtech Conference

Wed, 04 Mar 2026 08:50:00 -0500

Arlington, Virginia--(Newsfile Corp. - March 4, 2026) - The Association for the Advancement of Medical Instrumentation (AAMI) officially welcomes speakers from the U.S. Food and Drug Administration (FDA) to its upcoming medical device standards conference, AAMI neXus 2026.Dr. Michelle Tarver, Director of FDA's Center for Devices and Radiological Health (CDRH), will deliver a keynote at the conference. Attendees will join Tarver on Friday, April 17, 2026, to learn about "The Intersecting Roles of...

15,000 Professionals Take Part in Association for the Advancement of Medical Instrumentation

Wed, 18 Feb 2026 08:51:00 -0500

Arlington, Virginia--(Newsfile Corp. - February 18, 2026) - More than 15,000 health technology professionals and organizations are now leveraging the advantages of being a member of the Association for the Advancement of Medical Instrumentation (AAMI). This is a major milestone for the member organization's representation of the health technology field. AAMI recently crossed the threshold of 15,000 members throughout its core constituencies of the medical device industry, the industrial...

The State of HTM, 2025: Report Signals Changing Health Tech Workforce

Tue, 13 Jan 2026 09:41:00 -0500

Biomedical Engineers, Clinical Engineers, Others Weigh in on State of the Health Care Industry Arlington, Virginia--(Newsfile Corp. - January 13, 2026) - Approximately 1000 healthcare technology management (HTM) professionals across North America have participated in an expansive survey of their field. The insights of these essential healthcare personnel —including BMETs, clinical engineers, and management staff— resulted in the publicly available AAMI and TechNation 2025 State of HTM Report,...

AAMI Foundation Launches Michael Scholla Packaging Engineering Scholarship Fund

Wed, 10 Dec 2025 13:00:00 -0500

Calls for Contributions to Support Future Medical Device & Pharmaceutical Packaging Leaders Arlington, Virginia--(Newsfile Corp. - December 10, 2025) - The AAMI Foundation is pleased to announce the launch of the Michael Scholla Packaging Engineering Scholarship Fund, a new philanthropic initiative created to support students pursuing packaging engineering.The Foundation invites individuals, companies, and partners across the packaging and life sciences communities to contribute to the fund and...

AAMI Updates Medical Device Design Standard for First Time Since 2009

Tue, 18 Nov 2025 08:54:00 -0500

Association for the Advancement of Medical Instrumentation Brings Human Factors Guidance up to Date Arlington, Virginia--(Newsfile Corp. - November 18, 2025) - How medical professionals interact with medical devices is an increasingly vital consideration for the manufacturers who design those medical devices. The Association for the Advancement of Medical Instrumentation (AAMI) has updated its primary human factors engineering guidance for the medical device industry for the first time in over...