Abbott gets FDA clearance to bring FreeStyle Libre Pro CGM to US

By Jonah Comstock
01:19 pm

Abbott has received FDA Clearance for its FreeStyle Libre Pro system, a key milestone in bringing the company's unique take on the continuous glucose monitor to the United States. In Europe, where the system has had CE Mark clearance since September 2014, there is both a prescription and over-the-counter version available and the latter is smartphone compatible.

"FreeStyle Libre Pro transforms how doctors assess their patients' diabetes," Jared Watkin, senior vice president of diabetes care at Abbott, said in a statement. "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."

The FreeStyle Libre system is notable because it doesn't require fingersticks to calibrate and it has a lower cost than other CGMs on the market. The user wears a tiny insertable sensor and a patch on their arm for up to 14 days. The patch records glucose data every 15 minutes and uses NFC technology to transmit the data.

For the FreeStyle Libre Pro, which just got US clearance, the doctor uses a special NFC reader at the end of the monitoring period. And while the doctor recieves 14 days of continuous monitoring data, they don't have access to that data until the end of the monitoring period. But for the European version -- and likely for future US versions -- the consumer can read the data with either a special reader device or with their smartphone. European users have access to a Libre Link app as well as a new feature in mySugr.

Abbott is currently pursuing FDA clearance for the consumer version, according to the release. Though the company didn't specifically mention smartphone compatibility, it seems likely that the technology will follow a similar trajectory in the US that it did in Europe.


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