ABBOTT GETS CLEARANCE TO MARKET FREESTYLE SYSTEM
Abbott Diabetes Care has received 510(k) clearance from the FDA to market its FreeStyle Connect blood glucose monitoring system in the point-of-care setting (hospitals and medical clinics).
The FreeStyle Connect measures glucose levels using a very small blood sample size (0.3 micro liter) and provides results within an average of 15 seconds. The technology employed by FreeStyle Connect ensures reliable results under real-world conditions, with accuracy independent of blood oxygen levels. Further, many common substances -- namely aspirin, acetaminophen, gentisic acid, uric acid, vitamins, and many over-the-counter drugs -- do not affect results.
FreeStyle Connect also uses a technology based on coulometric measurement that measures virtually all of the available glucose in the blood sample, making it ideal for measuring a small sample size. The company intends to launch the FreeStyle Connect blood glucose monitoring systems this month.