Pacific's Osteopatch enters US trial:
This article was originally published in Clinica
Executive Summary
Pacific Biometrics has completed pilot clinical studies of the Osteopatch skin patch, designed for management of osteoporotic disease. The non-invasive system consists of a patented transdermal sweat collection device, assays for bone loss markers in sweat and a proprietary method for laboratory analysis. A US trial in 300 patients will begin soon and will take three to four months to complete, after which the company will make a 510(k) filing. 28 million people in the US are at risk for osteoporosis, a number that the National Osteoporosis Foundation believes will grow to 41 million by 2015.
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.