The first two months of 2022 have been chock full of huge developments in the diabetes corner of medtech. Tandem Diabetes Care is the latest company to achieve a significant milestone by winning FDA clearance of bolus insulin dosing on the t:slim X2 insulin pump using the t:connect mobile app.
The San Diego, CA-based company said this represents the first-ever FDA-cleared smartphone application capable of initiating insulin delivery on both iOS and Android operating systems.
Tandem said it intends to roll out the mobile bolus feature update throughout the spring in a series of limited launch groups, followed by an expanded launch later this summer. Limited launch participants have already been selected.
“This FDA clearance further validates our commitment to innovation and the diabetes community by providing one of the most requested feature enhancements,” said John Sheridan, president and CEO of Tandem Diabetes Care. “With the improvements in diabetes management provided by Tandem’s Control-IQ technology, giving a meal bolus is now the most common reason a person interacts with their pump, and the ability to do so using a smartphone app offers a convenient and discrete solution.”
Diabetes management has been hot in 2022, and we’re only two months in. January saw Acton, MA-based Insulet winning FDA clearance of Omnipod 5 Automated Insulin Delivery System, the first tubeless system with smartphone control.
As the month began to wind down the action in the space did not. Glooko made medtech headlines by dipping into the field of artificial intelligence to boost its diabetes offerings. To do this, the Palo Alto, CA-based company acquired xbird, a firm that has developed technologies to support patients and providers in predicting behavior and managing diabetes.
The biggest news in the space (so far), occurred earlier this month when Senseonics won FDA approval for the next generation Eversense 180-day continuous glucose monitoring system. The device was one of the 10 most anticipated new medical devices of 2021, but an FDA backlog delayed the approval timing. Originally, the Germantown, MD-based company submitted for FDA approval in October of 2020.
There are still more developments expected before the year is over. Arguably, one of the biggest announcements in the space could come from Senseonics’s rival Dexcom. The San Diego, CA-based company said its G7 CGM could obtain CE mark soon. Dexcom said it submitted to FDA but did not communicate a timeline of when the device could potentially win a nod.