The Latest News from AAMI


  • AAMI News, November 2020, Vol.55, No.11
    Issue Highlights
    • New Law Expands Telehealth for Veteran’s Mental Health Treatment
    • Study: Many De Novo Classified Devices Short on Effectiveness Data
    • Industry Examines Ways to Satisfy Need for Rapid Regulatory Response
    • Experts Address Roadblocks to Harmonization of EU Medical Device Standards
    Focus on Sterilization
  • AAMI News, October 2020, Vol.55, No.10

    Issue Highlights

    • 'Astronomical' FDA Research on Early Biomarkers
    • CMS Proposes Payment Pathway for Breakthrough
    • IoT Medical Devices Increasingly Vulnerable to Hacking
    • Telepsychiatry Holds Promise for COVID-19 Challenges
    • Deep-Brain Simulation Technology Uses AI
    • 3D Printing Helps Offset PPE Gap
    • Novel Standards for Unregulated Health Software
    • Sterilization Leaders Pool Knowledge in Unprecedented Collaboration

    Focus on Emerging Technologies

  • AAMI News, September 2020, Vol.55, No.9
    emergency equipment

    Issue Highlights

    • FDA Issues Second EUA for Heart Pump
    • A Full Slate of HTM Learning Events this Fall
    • Behind the Scenes at the FDA: MRI Safety Guidance
    • Just Published! AAMI HTM Succession Guide
    • Pediatric Device Competition Highlights COVID-19 Innovations
    • FDA Increases User Fees for 2021
    • In Memoriam: Zachary Collins
    • COVID-19 Medical Device Shortage List Posted by FDA

    Focus on Risk Management

  • AAMI News, August 2020, Vol.55, No.8
    hospital device with monitor

    Issue Highlights

    • FDA Delays UDI Enforcement
    • AAMI Foundation Establishes Kilmer Scholarship Fund Committee
    • AAMI Partners with Amplifire to Bring Cognitive Science, Analytics to Training
    • Looking for a Job or a Candidate? AAMI Career Center Can Help
    • “Must-Have” TIR24971 Complements Risk Management Standard

    Focus on: Service and Repair

  • AAMI News, July 2020, Vol.55, No.7
    human factors abstract

    Issue Highlights

    • AAMI Statement Against Racism and Intolerance
    • With Human Factors, Words Matter
    • AAMI’s Human Factors Webinar Series
    • Classifying Human Factors Issues for MAUDE and Recall Databases
    • AAMI Mourns Loss of Noted Clinical Engineer George Panagiotopoulos
    • What Can Amazon Teach Us About Defibrillators?
    • Understanding the Stages of ACI Certification
    • Demystifying Standards: A Journey into New Sterilization Standards

    Focus on: Human Factors

  • AAMI News, June 2020, Vol. 55, No. 6

    ANews_Home_June2020Issue Highlights

    • Manufacturers Reinvent Playbook for COVID-19
    • The Pros and Cons of N95 Mask Decontamination Methods
    • FDA Issues Final Guidance on Requesting Nonbinding Feedback 
    • Sterile Processing Department Takes on Vital New Role in COVID-19 Hot Spot
    Focus On: Healthcare Technology Appreciation
  • AAMI News, May 2020, Vol. 55, No. 5

    ANews_Home_MayIssue Highlights

    • Collaborative COVID-19 Response Brings Out the Best in HTM
    • AAMI, BSI Recommendations for Machine Learning
    • Potential Implications of the MDR Delay 
    • Upcoming Efforts to Improve Healthcare Cybersecurity
    Focus On: Cybersecurity
  • AAMI News, April 2020, Vol. 55, Issue 4

    Issue Highlights

    • AAMI Coronavirus Resources
    • FDA Pilots eSTART Program for Premarket Submissions
    • AAMI Education Rethinks the Education Experience
    • Olympus and Amplifire Team Up for Endoscope Processing
    Focus On: Sterilization
  • AAMI News, March 2020, Vol. 55, Issue 3
    Virtual Reality

    Issue Highlights

    • HTM Professionals Build and Implement VR Training Programs
    • FDA Reclassifies Medical Image Analyzers
    • AAMI Nominates Members for Board of Directors
    • Tech World: The Potential of Wearable Health Technology Devices

    Focus On: Medical Alarms

  • AAMI News, February 2020, Vol. 55, Issue 2
    Soft SkillsIssue Highlights
    • What You Need to Know About the New MDS2
    •  Medical Device Community Braces for Brexit
    • First Fully Disposable Duodenoscope Receives FDA Clearance
    • Health Technology Alliance: New Energy, New Activities
    Focus On: Soft Skills
  • AAMI News, January 2020, Vol. 55, Issue 1
    Robotic Assisted SurgeryIssue Highlights
    • Navigating E.U. Regulatory Reorganization under MDR
    • Recruiting the Next Generation with 'HTM in a Box'
    • A Call for More Detailed Metal Implant Labeling
    • More Innovators Enter the Robotic Space
    Focus On: Robotics
  • AAMI News, December 2019, Vol. 54, No. 12
    2019 in ReviewIssue Highlights
    • 2019—The Year in Review
    • FDA to Focus on Lowering Ethylene Oxide Emissions
    • CDRH Quality Pilot Expands to Noncompliant Manufacturers
    • AAMI's Healthcare Technology Collection Puts Innovation on Display
    Focus on: The Year in Review
  • AAMI News, November 2019, Vol. 54, No. 11

    Issue HighlightsAugmented Reality

    • FDA Outlines Details of Proposed ASCA Pilot Program
    • Ambulatory Surgery Centers: A Growing Medical Device Market
    • FDA Encourages Patient Engagement in Device Development
    • New Augmented Reality Imaging Tool Helps Guide Surgeons

    Focus On: Imaging

  • AAMI News, October 2019, Volume 54, Issue 10
    SterilizationIssue Highlights
    • What Does It Mean to Design for Failure?
    • AAMI Foundation Embarks on New Direction
    • FDA Guidance Considers Uncertainty in Benefit-Risk Determination
    • AAMI, ISO Publish Sterilization Standards for Packaging

    Focus On: Sterilization

  • AAMI News September 2019, Volume 54, Issue 9

    Hurricane SeasonIn this issue:

    • For Hurricane Season, FDA Offers Safety Tips for Medical Devices
    • New Type of AAMI Resource Aims to Address Need for Rapid Guidance
    • FDA Announces Two Innovation Challenges for Ethylene Oxide Sterilization Alternatives
    • AAMI Nominee Wins IEC Young Professionals Competition
    Focus On: HTM Education and Development