FDA clears Provalis' POC (point-of-care) diabetes monitor:
This article was originally published in Clinica
UK company Provalis has received US FDA 510(k) clearance to market its point-of-care diabetes monitor. Glycosal, a simple four-minute test for glycated haemoglobin, can be used to help monitor the severity of diabetes and the effectiveness of long-term therapy. The device measures a diabetic's average level of glucose over the last three months by measuring a specific fraction of the patient's haemoglobin called HbA1c. Deeside-based Provalis said that the product is already available in over 20 markets in Europe, South America and the Far East. It will now apply for a CLIA waiver to bring the testing device to a larger market in the US.