Despite industry confusion and concerns, the FDA has unveiled a long-anticipated final rule designed to create consistent, complete postmarket safety reporting requirements for combination products.

Diabetes patients have scored a big win after San Diego's Dexcom Inc. announced Tuesday the expanded approval of its G5 mobile continuous glucose monitoring (CGM) system to guide treatment decisions. Dexcom said its offering will be the first CGM system allowing for treatment decisions without finger pricking, instead requiring only two finger pricks a day for calibration purposes. G5 includes wireless Bluetooth technology that sends glucose data to a user's smartphone. It had already picked up FDA approval for the adjunctive use of the system to complement finger sticks.

With an eye toward promoting minimally invasive procedures and treating colorectal disease within a patient's intestine, Westport, Conn.-based Lumendi LLC has scored a win at the U.S. FDA with its new device.