510(k) for Genzyme Diagnostics:
This article was originally published in Clinica
Genzyme Diagnostics has received FDA 510(k) clearance to market its GlyPro assay for monitoring blood glucose levels in diabetic patients. By measuring the level of glycated serum proteins, commonly known as fructosamine, the test presents doctors with a representative measurement of the average blood glucose levels from the previous two to three weeks. This offers a cost-effective way of measuring glucose control over time, said the Cambridge, Massachusetts-based company.
You may also be interested in...
The addition of the question “Was this device serviced by a third party servicer?” to adverse event reports filed through the US FDA’s electronic Medical Device Reporting system could prove helpful for the agency and device makers, experts tell Medtech Insight. Industry has long complained about poor work performed by servicers – and loudly groused that they’re not regulated.
Attorneys tell Medtech Insight a recent proposal to review regulations every 10 years could lift some burdens from the medical device industry, but warned that the full effects may not be seen for some time.
A nasal spray formulated using compounds already approved by regulatory bodies in Europe and the US can “prevent and slow” transmission of COVID-19, according to UK researchers who are now seeking a partner to commercialize the product.