Implantable CGM company Senseonics has received approval from the FDA for the non-adjunctive indication for its Eversense device.
Senseonics is only the third company to secure this indication, which allows a CGM to be used for insulin dosing in lieu of a fingerstick glucometer, though patients will still need to use fingersticks twice a day for calibration.
The company plans to go live with the...
For folks managing their diabetes with Dexcom, Siri can now answer one more question: What is my glucose level? This morning Dexcom announced a slew of new companion app features for the Dexcom G6 continuous glucose monitoring system, including the ability for Siri to read a user’s glucose level out loud and display graphs directly on the lock screen.
The app, which was released in 2018, will...
Dexcom held its Q4 2018 earnings call last week, reporting an overall very strong year, but also announcing outsourcing plans that will likely lead to layoffs in the US.
The company broke $1 billion in annual revenue in 2018, CEO Kevin Sayer said on the call, while increasing adoption, especially in Medicare and international markets, both of which are new to the company. And the company has set...
Researchers who use Fitabase to capture data from Fitbit and Garmin devices will soon be able to capture a new kind of data: continuous glucose monitoring data from Dexcom products.
The ability to capture glucose values, as well as calibrations, syncs, and alerts, from Dexcom CGMs will allow researchers to study the interplay between blood glucose and the activity, heart rate, and sleep — the...
This morning diabetes data management company Glooko announced that two soon-to-be released Novo Nordisk connected insulin pens will now be connected to the former’s diasend platform. The connected pens are expected to launch in early 2019, and will include Novo Nordisk’s NovoPen 6 and NovoPen Echo Plus.
As part of today’s announcement Glooko also revealed a new compatibility feature for the ...
On its third quarter earnings call last week, Dexcom recapped a busy Q3 — of note, one that included the acquisition of TypeZero Technologies for $11.3 million in August as well as two new FDA clearances in October and November. One of these clearances was for a new mobile app interface for the Dexcom G6 while the other was the Dexcom Pro Q CGM, a new disposable glucose monitoring device intended...
Shortly after launching its integrated continuous glucose monitoring system, Dexcom announced a 42 percent increase in year-over-year sales during its Q2 earnings call.
“Not only did we exceed our annual growth guidance for the second consecutive quarter but the business continues to accelerate,” Kevin Ronald Sayers, CEO of Dexcom, said during the call. “All of our key segments demonstrated...
Dexcom started out the year strong following the FDA clearance of its integrated continuous glucose monitor the G6. In its Q1 earnings call, the company reported a 30 percent increase in revenue compared to Q1 of 2017, bringing its total revenue to $184 million.
When the FDA gave Dexcom the nod for the G6 it became the first interoperable CGM to get the designation. According to the earnings call...
Fitbit has announced a slew of new digital health apps and clock faces that were born out of partnerships with major players such as Dexcom, Humana, and Walgreens. The apps, which were built on Fitbit’s software development kit, are aimed at helping people manage chronic conditions and improving overall health.
“Smartwatches provide a powerful platform to deliver important health tools that help...
In the last quarter the FDA gave the nod to 10 digital health devices. Innovations that aimed to help diabetes management were popular, ranging from the first integrated continuous glucose monitor, which was put out by Dexcom, to Glooko’s insulin titration tool.
Not all FDA news this quarter was good news. In February Roche’s Accu-Check Connect Diabetes Management App was recalled by the FDA for...
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