Abbott Laboratories received FDA clearance for its Freestyle Libre 3 continuous glucose monitoring system (CGM) just before the kickoff of the American Diabetes Association (ADA) annual meeting June 3 followed by breakthrough device designation for a combined CGM and continuous ketone monitoring system.
Insulet Corp. received FDA clearance for its Omnipod 5 closed-loop automated insulin delivery (AID) system for patients aged six and older who have type 1 diabetes on Friday, Jan. 28, making it the first tubeless “artificial pancreas” system to get the FDA greenlight. The Omnipod 5 works with Dexcom Inc.’s widely used G6 continuous glucose monitor (CGM) to self-adjust insulin dosing using its Smartadjust algorithm.
SAN FRANCISCO – Insulet Corp. aims to get an FDA approval this year and launch its first interoperable device, the cord-free, wearable insulin device Omnipod Horizon. It is designed to be compatible with the Dexcom G6 and is the result of a partnership between the two companies. In combination, the devices will operate as a closed loop system to automatically adjust insulin dosage over time in response to blood glucose levels.
SAN FRANCISCO – Dexcom Inc. is working hard to take its business to the next level. Wall Street has been rewarding it heavily, doubling its market cap to about $21 billion since the end of 2018. But investors pulled back a tad on the company’s presentation at the J.P. Morgan (JPM) Healthcare Conference in San Francisco, sending shares down about 4% despite beating analyst expectations.
Diabetes management company Dexcom Inc. trounced Wall Street forecasts for the third quarter of 2019, with the company reporting worldwide sales of $396.3 million, up 49% from $266.7 million in the same period of 2018. Dexcom officials attributed the surge to volume growth plus new patient additions as providers and consumers become more aware of the benefits of real-time continuous glucose monitoring (CGM), where Dexcom's G6 has seen steady demand since launching in June 2018.