Mereteck Diagnostics
This article was originally published in The Gray Sheet
Executive Summary
FDA grants 510(k) clearance for BreathTek UbiT breath test kit for diagnosis of active Helicobacter pylori infection, the primary cause of peptic ulcer disease, the firm announces Feb. 4. Enhancements over the firm's previous-generation UBT and UBT Lite breath tests include using the UbiT IR 300 infra-red spectrophotometer instead of a gas isotope ratio mass spectrometer. Shipments will commence immediately...
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.