COVID-19: New Emergency Guidance From AAMI Targets Remote-Controlled Devices
Executive Summary
Consensus report CR511 from the Association for the Advancement of Medical Instrumentation highlights common system elements for engineers, and outlines safety and risk-control measures that manufacturers and caregivers should consider.
You may also be interested in...
COVID-19: FDA Expands List Of Remote Monitoring Devices That Don’t Need Premarket Notification
The US agency has added gaseous-phase carbon-dioxide gas analyzers to its list of products that – during the coronavirus pandemic – will not require a new premarket notification to be marketed for remote monitoring.
Speaking Of Medtech, Ep. 10: FDA’s TAP Pilot
In this FINAL EPISODE of Speaking Of Medtech: The US FDA got something it desperately wanted in its latest user-fee package with industry: a Total Product Lifecycle Advisory Program pilot, or TAP. The agency says TAP will allow for earlier and more frequent engagement with developers – but is it needed?
Thumbs Up: FDA Authorizes Weight Loss Suturing Systems From Apollo Endosurgery
People with obesity now have new tools to help them lose weight, thanks to the US agency’s de novo authorization.