Abbott wins FDA nod for Freestyle Libre Pro

Abbott (NYSE:ABT) said today it won FDA premarket approval for the FreeStyle Libre Pro continuous glucose monitoring system designed for use by healthcare professionals to treat patients with diabetes.

The FreeStyle Libre Pro professional use device uses a patient-worn sensor to track blood glucose levels for up to 14 days. The sensor is applied by a healthcare provider to the back of the upper arm, measuring glucose levels every 15 minutes in interstitial fluid via a small filament inserted just under the skin, the Abbott Park, Ill.-based company said.

“FreeStyle Libre Pro transforms how doctors assess their patients’ diabetes. This novel technology provides a solution to the ongoing challenge of the need for complete and dependable glucose data. This data is imperative for not only the doctor, but also for the patient to help them achieve optimal health,” diabetes care senior veep Jared Watkin said in a press release.

Data from the FreeStyle Libre Pro Flash can be wirelessly downloaded at the provider’s office in about 5 seconds,. Abbott said. The system is the 2nd in Abbott’s Flash glucose monitoring line, following a personal-use version called FreeStyle Libre that launched in Europe last fall.

The device eliminates the need for fingerstick calibration, and patients are not required to interact with the device during use. The FreeStyle Libre system records glucose levels every 15 minutes, with up to 1,340 readings over its 14 day monitoring period.

After 14 days, healthcare professionals are provided with a detailed report – an ambulatory glucose profile – to aid in making informed care decisions.

“My patients are often out of range, due to inconsistent self-monitoring and insufficient data from traditional glucose meters that are unable to provide a full view of their glucose levels. This technology is groundbreaking because continuous glucose monitoring systems for professional use have been long considered a niche, cumbersome, and expensive technology for mostly Type 1 patients. The FreeStyle Libre Pro system changes this paradigm not only because of the unique technology but because it doesn’t require fingerstick calibration, is easier to use, more affordable, and is more accessible to people with diabetes,” Dr. Eugene Wright of Fayetteville, N.C.’s Duke Southern Regional Area Health Education Center said in prepared remarks.

In April, regulators in India approved the FreeStyle Libre Pro Flash, which Abbott touted as the 1st approval of the novel diabetes care device.

The company said it planned to launch the device in 6 Indian cities including Mumbai, Delhi, Chennai, Bangalore, Pune and Trivandrum. Abbott diabetes care senior vice president Robert Ford said India carries 20% of the global burden of diabetes, citing the “immense need” there for better management tools for patients.

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