The Latest News from AAMI
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AAMI News, January 2021, Vol.56, No.1
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AAMI News, December 2020, Vol.55, No.12
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AAMI News Special Standards Issue
Learn what's going on in the world of standards, and get introduced to AAMI's new and longtime standards staff in this special edition of AAMI News!
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AAMI News, November 2020, Vol.55, No.11
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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
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AAMI News, September 2020, Vol.55, No.9
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
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AAMI News, August 2020, Vol.55, No.8
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
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AAMI News, July 2020, Vol.55, No.7
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
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AAMI News, June 2020, Vol. 55, No. 6
Issue 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
- Manufacturers Reinvent Playbook for COVID-19
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AAMI News, May 2020, Vol. 55, No. 5
Issue 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
- Collaborative COVID-19 Response Brings Out the Best in HTM
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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
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AAMI News, March 2020, Vol. 55, Issue 3
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
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AAMI News, February 2020, Vol. 55, Issue 2
Issue 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
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AAMI News, January 2020, Vol. 55, Issue 1
Issue 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
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AAMI News, December 2019, Vol. 54, No. 12
Issue 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
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AAMI News, November 2019, Vol. 54, No. 11
Issue Highlights
- 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
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AAMI News, October 2019, Volume 54, Issue 10
Issue 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
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AAMI News September 2019, Volume 54, Issue 9
In 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