The Centers for Medicare and Medicaid Services will reverse a longstanding unpopular position on reimbursement for smartphone-connected continuous glucose monitors, CMS announced yesterday.
"CMS heard from numerous stakeholders who shared their concerns that Medicare’s CGM coverage policy limited their use of CGMs in conjunction with their smartphones, preventing them from sharing data with...
Yesterday Dexcom got the nod from the FDA to market their Dexcom G6, an integrated continuous glucose monitoring system (iCGM), making it the first interoperable CGM to get the designation.
“We are a company of firsts, almost everything that has been done in our industry has been done by us first,” Dexcom CEO Kevin Sayer told MobiHealthNews, citing that Dexcom was the first company to have a...
It was good news for Dexcom in January when the Centers for Medicare and Medicaid Services announced they would reimburse for Dexcom’s — and initially only Dexcom’s — continuous glucose monitor. Now the rollouts to Medicare patients are starting, although the company isn’t exactly rolling in that government money. In fact, CEO Kevin Sayer said on a recent earnings call that they’ve yet to see a...
At long last, Dexcom's Share app, which allows users to view and share data from their G5 continuous glucose monitors, will be available for Android users. The Android app just now received FDA clearance, and the company will roll out the app this month. The launch is a long time coming: iOS users have had access to the app since 2015.
“Providing Android users with access to the Dexcom G5 Mobile...
In January, the Centers for Medicare and Medicaid Services announced that it would cover continuous glucose monitoring for the first time; specifically it would cover therapeutic CGMs, of which the only one currently recognized is the Dexcom G5. That coverage officially kicks in today, now that CMS has issued the billing codes providers can use to get reimbursed.
“This is a new era and a huge win...
The Centers for Medicare and Medicaid Services has deemed certain therapeutic continuous blood glucose meters (CGMs) as durable medical equipment and thus are eligible for coverage.
It’s not all cut and dry, of course. Eligible devices must fit several definitions: they must be a class III, FDA-approved device, and they must be CGMs that measure blood glucose levels periodically by using sensors...
The FDA has officially cleared the Dexcom G5 continuous glucose monitor to inform treatment decisions -- without the use of a fingerstick glucometer, other than for calibration. The G5 has been cleared for a while to complement a traditional glucometer, but this non-adjunctive clearance is the first of its kind according to Dexcom and the FDA, which both released statements.
"The FDA works hard...
A new clinical trial to investigate the use of artificial pancreas system is set to begin, bringing in touchscreen insulin pump maker Tandem Diabetes Care; Dexcom, which makes continuous glucose monitor; and digital, personalized medicine company TypeZero Technologies.
The International Diabetes Closed Loop trial, funded by a grant from the National Institutes of Health to the University of...
Dexcom’s biggest triumph and its biggest let down this quarter both involved the FDA. On the positive side, a verdict from a special FDA panel means Dexcom may soon be able to change its CGM’s intended use to replace fingerstick glucometers. On the negative side, a voluntary device recall this quarter that potentially affected all of Dexcom’s receivers led to higher-than-expected Q2 losses....
The Dexcom G4 receiver
Continuous glucose monitors are right now a good tool for a certain subset of people with diabetes, but there's still a majority of people, especially with Type 2 diabetes, for whom fingerstick glucometers are still the cheaper, more convenient option. Dexcom wants to change that.
On a second quarter earnings call, EVP of Strategy and Product Development Steve Pacelli ...
