Are Investors Growing Impatient for FDA Approval of Abbott & #039;s Libre 2 iCGM?

Abbott Laboratories has been wildly successful with its FreeStyle Libre continuous glucose monitor (CGM) since winning FDA approval two years ago, but some investors may be getting restless as the U.S. market waits for the second-generation of the blockbuster technology. Abbott won CE mark approval to launch the Libre 2 system in Europe in October 2018. The second-generation system offers optional customizable glucose alarms for patients who need them, using Bluetooth technology. The system can be set up to alert the user if their glucose is low or high, for example, or if there is a signal loss between the sensor and the reader. The user continues to be able to scan their sensor as often as desired to see their glucose reading, trends and patterns, and eight-hour history. The company filed for FDA approval of Libre 2 as an interoperable continuous glucose monitoring (iCGM) system, meaning it will need to meet the special controls established by FDA when the agency authorized the Dexcom G6 iCGM in May 2018. Abbott's management team has previously assured investors that the company would not have submitted Libre 2 as an iCGM had it not clearly met the standards set by FDA. In fact, the company said it was encouraged by the agency to file Libre 2 as an iCGM. But analysts and investors are beginning to get antsy, and Morgan Stanley's David Lewis mentioned during Abbott's third-quarter earnings ca...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news