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In June, the FDA offered up a draft guidance document designed to help medical...
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...
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....
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...
When it comes to patient-generated health data, the biggest roadblocks often come when its time to integrate that data into the doctor's workflow and the existing doctor-patient relationship. For pediatric patients with type 1 diabetes, some doctors seem to have figured it out. A group of Stanford physicians and researchers has published a study in the Journal of the American Medical Informatics...
When the Apple Watch launched last year, Dexcom announced that it would have an Apple Watch app ready for its G4 continuous glucose monitor system, and it did. While users could see their CGM data on their wrist, that data had to go on a long trip to get there. With the G4, the implant sent data to a receiver box which sent data to the phone which sent data to the watch, and the user needed to...
When Kenneth Stack's son was diagnosed with Type 1 diabetes just before his fifth birthday, the doctor told Stack he was just a few years too early for a major medical breakthrough.
"I remember, trying to make sense of all of this, the doctor saying 'In three years, we’ll have perfected the artificial pancreas and you won’t have to worry about this'," Stack recalled at a panel discussion at the...
The FDA has approved San Diego, California-based Dexcom for a Bluetooth-enabled continuous glucose monitor (CGM), called the G5 Mobile CGM system.
Correction: A previous version of this article incorrectly stated the device had a 510(k) clearance when in fact it had a PMA approval.
Unlike the company's previous connected CGM devices, the G5 Mobile CGM System has Bluetooth built right in to the...
The old Dexcom Share, with charging cradle.
DexCom has partnered with Google Life Sciences to develop the next generation of DexCom's CGM -- a device that is "the size of a dime", less expensive than current CGMs, and that the companies hope will eventually replace the fingerstick glucometer. The device is not just for people with Type 1 diabetes but also for those with Type 2 diabetes.
"Our...
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 ...
.jpeg?itok=HF3iI7dj "Person answering their front door and getting a delivery from another person")
