FDA okays Powerheart for use outside hospitals:
This article was originally published in Clinica
Executive Summary
Cardiac Science says it has received a notification from the FDA that allows it to sell its fully automated Powerheart defibrillator-monitor for out-of-hospital applications in the US. The system, which was cleared by the FDA for hospital-use last year, prophylactically monitors cardiac patients for the detection of life-threatening heart rhythms and delivers defibrilliation shocks within seconds without human intervention. It can now be used in outpatient or doctors' office settings, says the Irvine, California company.
You may also be interested in...
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.
EU Parliament Stricter Than Council On Medicines And Medical Devices Packaging
The EU Parliament's Environment, Public Health and Food Safety committee takes a compromise position with regards to the Packaging and Packaging Waste Directive. Medicines and medical devices should be exempt, but only until 2035, at which point the European Commission should check whether the development of materials and the recycling process have progressed, and may adjust this exemption accordingly.
Stay Or Exit? Global Health Players Ponder New China Trajectory
It's again the time of year when global CEOs descend on China's capital to discuss strategies. This year, however, the mood is different.