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...
Fitbit confirmed the rumored acquisition of Pebble today, but clarified that it is not acquiring the business in its entirety -- only the software IP and some personnel. Notably, Fitbit won't take on Pebble's debts or it's hardware assets, which the company could still sell in a separate deal, and Pebble CEO Eric Migicovsky will not start a job at Fitbit. Instead, according to a report in...
As their famous rallying cry states, the patients behind the Nightscout project for creating a do-it-yourself mobile technology for diabetes management are not waiting for approval from the FDA. But that doesn't mean they aren't seeking it, or that they haven't been in contact with the regulatory organization to make sure Nightscout is as safe as it can be.
In a new editorial published in the...
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...
Dexcom was one of the first companies to announce that it would have an Apple Watch app, and a recent FDA guideline made it clear that, as a secondary display device for a cleared CGM, the Apple Watch app wouldn't require its own clearance.
But users of other smartwatches, including the Pebble Watch and the Android devices have also had access to Dexcom CGM readings, just not through an...
Dexcom's Apple Watch app will be ready to go when the device launches in April, the company told the Wall Street Journal. The app, which will not need to seek pre-market approval from the FDA thanks to a recent reclassification, will allow the Apple Watch to serve as a secondary display device for the Dexcom G4 (and upcoming G5) continuous glucose monitor system. The primary display will remain...
