AAMI News August 2018, Volume 53, Issue 8
U.S. medical device manufacturers have found themselves in the middle of the escalating trade dispute with China.
A proposed rule by CMS that would tie interoperability, in terms of the electronic exchange of information, to funding has received a mixed reaction from industry groups.
As part of the FDA's ongoing effort to modernize the regulation of digital health technologies, the agency released a second draft of its Digital Health Software Precertification (Pre-Cert) Program framework earlier this summer.
A proposal by the FDA to “modernize” its approach to clearing moderate-risk devices by establishing an expanded version of the Abbreviated 510(k) program was met with a tepid response.
- News in Brief
- ACI Board Seeks Feedback on Possible Retirement of Three Certifications
- AAMI Standards Board Approves Development of Six Items
- A Biomed’s Mission Abroad Seeks Justice in Healthcare
- Postcards from the Field: Military BMET Training Program Is on the Frontlines of Technology
- Apps Could Help Detect Signs of Mental Health Issues
- FDA Approves First Glucose Monitoring System with Implantable Sensor, App
- Tech World: From IT to the OR, Biomed Shares Lesson Learned
- The Big Picture: AAMI University
- Asked & Answered: Biological Testing
- Career Center: Sterile Processing Expert Overcomes Fear to Find Success as Public Speaker
- One on One with Stephanie Domas
- AAMI All-Star: Karen Waninger
- Members on the Move
- Standards Spotlight: New TIR Focuses on Protecting Processing Professionals from Chemical Hazards
- Advertisers in this Issue