The FDA’s device center reported the addition of four device types to the ranks of class II devices, including one each for de novo petitions by Apple Inc., of Cupertino, Calif., and Roche Molecular Systems Inc., of Pleasanton, Calif.
Diabetes care will continue to evolve in 2022. New digital offerings and advanced algorithms, along with new product launches in insulin pumps and continuous glucose monitoring (CGM) will power growth in the future, according to key analysts. While many medical device sectors have suffered during the COVID-19 pandemic, diabetes care has continued to grow.
Abbott Laboratories and Tandem Diabetes Care Inc. have finalized an agreement related to integrated diabetes solutions. Specifically, the duo is planning to combine Abbott's Freestyle Libre continuous glucose monitoring (CGM) technology with San Diego-based Tandem's insulin delivery systems, with an eye toward providing more options for diabetes management.
Over the last few years, Wall Street has fervently embraced the largest diabetes technology companies, particularly those behind continuous glucose monitors, insulin pumps, and the automated closed loop systems that incorporate both to work together.
San Diego-based Tandem Diabetes Care Inc. reported financial results for the third quarter of 2019, with worldwide pump shipments soaring 112% to 17,839 pumps from 8,434 pumps in the same period a year ago. Revenue rose 105% to $94.7 million, up from $46.3 million in the third quarter of 2018.
Abbott Laboratories and Tandem Diabetes Care Inc. said Tuesday that they plan to develop and commercialize a line of integrated diabetes products based on Abbott's glucose sending technology and Tandem's insulin delivery systems. The collaboration comes as the U.S. FDA is encouraging medical device manufacturers to consider the ability to share and use information safely and effectively in the development and design of connected devices.
