|Abbott's FreeStyle Libre Flash--Courtesy of Abbott|
Abbott ($ABT) has already made strides with its finger-stick free glucose monitoring system, snagging a CE mark for the product in 2014. Now the company is building on that success after the device recently won European approval for use in children, a feather in the company's cap as it aims for similar regulatory blessings in the U.S.
The Illinois-based company's FreeStyle Libre Flash glucose monitoring system got a green light for kids aged 4- to 17-years-old with diabetes. The system includes a sensor worn on the back of the arm for 14 days that monitors glucose levels through a tiny filament. Unlike other continuous glucose monitors, the device doesn't require a twice-daily finger-stick blood glucose measurement or finger-prick calibration, perks that Abbott is quick to crow about.
A recent accuracy study of the system in children showed that it was "accurate, stable and consistent" without finger-prick calibration, the company said in a statement. And almost all of the children and teens included in the study said that the device is easier to use than finger-prick testing.
"Children and teens with diabetes and their families have to navigate many challenges in their daily lives as they care for this complex condition," Abbott's SVP of Diabetes Care Jared Watkin said in a statement. "The scientists and engineers at Abbott have made it their life's work to provide the most innovative technology to help people with diabetes improve their diabetes management and ultimately, live happier and healthier lives."
The latest approval builds on the system's previous success in Europe. In 2014, FreeStyle Libre Flash got a CE mark for adult patients. The device "fulfills a major need for people living with diabetes," as patients look for other options to avoid "the pain, inconvenience and indiscretion of finger pricking," Abbott's former SVP of Diabetes Care Robert Ford said at the time,
Now, with two European regulatory blessings in tow, Abbott is setting its sights on stateside approval for its device. FreeStyle Libre Flash "has been exceptionally well received in Europe" and the "diabetic community in the United States wants this product," Abbott's VP of Investor Relations Scott Leinenweber told investors during the company's Q4 earnings call. Even though a typically slower regulatory process in the U.S. could throw down some obstacles for Abbott, the company is staying positive about approval for FreeStyle Libre Flash.
"I'm one of those superstitious people that no matter what I tell, I'm going to be wrong. And so I don't want to jinx anything. So I'll say, I would optimistically hope toward (approval) this year, but I don't know," Leinenweber said.
- here's the statement
- check out the transcript at Seeking Alpha