The Manila Times on MSN1mon
Boost to medical device classification
The task force will help in solving the problems in the approval or registration of stakeholders for medical devices. The FDA will now be able to make the classifications based on the Asean ...
WebMD1mon
FDA-Cleared Medical Devices Lack Proper Vetting, Doctors Say
The FDA considers devices approved through this “501(k ... may be to blame for the lack of clinical evidence in most class I recalls, according to a commentary that came with the new study. “ ...
FDA Grants De Novo Authorization to OMRON Healthcare for New Blood Pressure Monitors with AI-Powered AFib Detection Feature
In a pivotal stride to address the growing AFib epidemic, OMRON Healthcare today announced the U.S. Food and Drug ...
ResMed product recall classified as most serious by FDA (update)
Update 03.16 PM EST: Adds comments from ResMed The U.S. Food and Drug Administration ... for its respiratory care devices, ...