Abbott wins FDA approval for diabetes device that doesn't require routine finger pricks
The U.S. Food and Drug Administration approved Abbott’s FreeStyle Libre Flash Glucose Monitoring System for adults, which already is sold in 41 other countries.
Abbott Laboratories has gained clearance to start selling in the U.S. the first continuous glucose monitor that does not require people with diabetes to routinely prick their fingers.
The U.S. Food and Drug Administration on Wednesday approved Abbott’s FreeStyle Libre Flash Glucose Monitoring System for adults, which already is sold in 41 other countries.
The device consists of a small sensor, about the size of a quarter, that’s worn on the back of the upper arm to continuously track glucose levels. The sensor, unlike other wearable sensors, does not require patients to prick their fingers for calibration. Patients can place a hand-held reader near the device to see their current glucose levels, trends, patterns and where those levels might be headed. They can then use those readings to figure out how much insulin to take to manage their diabetes.
The device has not yet been approved for use by children in the U.S. but Abbott hopes to gain approval from the FDA.
The company is not disclosing pricing information until it gets closer to launching the product in the U.S., which will likely be before the end of the year, said Abbott spokeswoman Vicky Assardo. But she said in an email the price will be “very similar” to the price in Europe, where the reader costs about $69, and each sensor, which lasts about 14 days, also costs about $69, before insurance. In the U.S., the sensor will last about 10 days.
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