Dexcom Scores Nod for First Interoperable CGM

Dexcom is once again shaking up in the continuous glucose monitoring (CGM) market. The San Diego-based company has received the green light from the FDA to market the Dexcom G6 CGM System, a device that is interoperable with other automated insulin dosing  systems. FDA said this is the first device that has been given approval to work with other compatible technologies. The agency also said its decision classifies Dexcom’s CGM as a less stringent medical device and enables a speedier review for similar future systems. “The ability of this device to work with different types of compatible devices gives patients the flexibility to tailor their diabetes management tools to best meet personal preferences,” said Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health, in a release. “In addition, FDA has taken steps to expedite the review process for similar, integrated CGMs and make these types of systems available to patients as quickly as possible while also helping to ensure their safety and reliability.” Join us at the BIOMEDevice Boston Expo,  April 18–19, 2018. Use promo code "MDDI" for 20% off conference registration and free expo access.   Dexcom said the CGM also removes the need for fingerstick blood testing for people with diabetes. The Dexcom G6 is a patch device, about the size of a quarter, that is applied to the skin of the abdomen and contains a small sens...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news