DexCom

By Jonah Comstock February 9, 2017
The National Institute of Diabetes and Digestive and Kidney Diseases, a part of the National Institutes of Health, has given out $41 milion in grants to four studies that will hopefully make the artificial pancreas – a long-sought, fully automated, closed-loop system for insulin regulation – a reality. Two of the studies are underway and two more are slotted to begin recruiting in the next two...
By Heather Mack January 14, 2017
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...
By Heather Mack December 13, 2016
When it comes to regulating medical devices, the status quo of relying on premarket evidence has its limitations: it’s expensive, it’s time-consuming, and it isn’t necessarily the best data to show how something truly operates in everyday life. But, according to a panel at the Connected Health conference in Washington, D.C, digital health tools that generate a trove of data could put us on...
By Heather Mack November 16, 2016
EHR vendor Cerner has tapped telehealth provider American Well to deliver its virtual health care offerings. Through the partnership, American Well’s platform will integrate with Cerner’s EHR and be made available to all current and future Cerner and American Well clients. Patients will access the virtual care offering through Cerner’s HealtheLife patient engagement portal, which also provides...
By Heather Mack November 10, 2016
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...
By Jonah Comstock October 18, 2016
Common Sensing, a Cambridge-based company developing a smart connected insulin pen cap, announced that it will test its device in a clinical trial in collaboration with Joslin Diabetes Center, Sanofi, and Dexcom. The study of 125 subjects will be conducted by Joslin and funded by Sanofi. Patients will be given a Gocap from Common Sensing, a cap that fits on to a disposable insulin pen and can...
By Heather Mack October 7, 2016
As we take a look at the devices that received FDA clearance in 2016's third quarter, we're also considering that the last few months have been a time of change at the Food and Drug Administration, as regulators are beginning to make updates in their system to accomodate all the digital health tools we're seeing.  In June, the FDA offered up a draft guidance document designed to help medical...
By MobiHealthNews August 12, 2016
Over the years, more and more companies have gone public in the digital health space and existing public companies have gotten into the space, either on their own or thorugh acquisitions. Here's a roundup of digital health talk on the latest round of second quarter investor calls and quarterly finance reports. Fitbit. San Francisco-based Fitbit, maker of a series of popular wearable activity...
By Jonah Comstock August 3, 2016
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....
By Heather Mack July 22, 2016
An FDA advisory panel has voted in favor of recommending a change to the intended use of Dexcom’s G5 Continuous Glucose Monitor (CGM). The G5 had already been FDA-approved, but with limitations as an adjunctive device, meaning it could only be used for tracking and trending interstitial fluid gluocose concentrations rather than as a full replacement for a traditional fingerstick blood glucose...