Polymer Technology OTC Triglyceride Test Performance Data Insufficient
This article was originally published in The Gray Sheet
Executive Summary
Polymer Technology Systems, Inc., should generate data demonstrating that its MTM BioScanner 2000 test strips intended for over-the-counter triglyceride testing comply with performance thresholds set by the National Cholesterol Education Project, FDA's Clinical Chemistry and Clinical Toxicology Devices Panel concluded at an Oct. 28 meeting.
You may also be interested in...
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.
Report Finds Digital Diabetes Tools Deliver No ‘Meaningful Clinical Benefits'
A new report from health economics group the Peterson Health Technology Institute found that apps to help patients manage their blood sugar levels delivered few of the promised benefits. However, a digital therapeutics industry association says PHTI’s research cast too narrow a net.