Abbott Earns CE Mark For FreeStyle Libre Bloodless Glucose Monitor
This article was originally published in The Gray Sheet
FreeStyle Libre reads glucose levels through a interstitial fluid sensor on the back of the patient’s arm, but unlike current continuous glucose monitors does not require finger-stick calibrations.
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The FreeStyle Libre Pro is intended to provide health-care providers with an easy-to-read visual summary of a diabetic patient's glucose data. Abbott has also filed for approval with FDA for a consumer-targeted version of the device.
The quest to bring an artificial pancreas to market has taken some giant steps forward recently, as major players continue to produce impressive data from clinical studies that measure the use of various insulin pumps, continuous glucose monitors (CGMs), and algorithms. Improvements in CGM sensor technology have helped move AP research, and competition is proving to be a driving force on the road to producing a commercial product that could be within two or three years from reaching the market.
Johnson & Johnson and Abbott Laboratories each reported massive double-digit revenue drops for their U.S. diabetes product divisions in earnings reports this week, citing the impact of the national Medicare competitive bidding program for diabetes supplies. Roche had better-looking results for the most recent quarter, but also has taken a big hit from massive reimbursement cuts resulting from nationwide bidding.