Dexcom’s Wins, Apple’s Goof, Denmark’s Investment
The Pancreatic Algorithm
Dexcom has won FDA approval for an algorithm that mimics how a pancreas measures blood glucose levels. The algorithm would be downloadable for users of the popular G4 platinum continuous glucose monitor, according to a MedGadget report. This would be the same algorithm that is used in experiments involving artificial pancreas devices, so it seemingly paves the way for better pump technology in the days to come.
Sharing is Caring
Dexcom also celebrated a regulatory win with its G4 continuous glucose monitor when the FDA approved an add-on for the device that allows people to share their blood glucose readings with up to 5 “followers”. According to a Fierce Medical Devices report, the Dexcom Share allows users to upload their readings with an app and then share it with followers who use Apple products.
It begs the question as to whose blood glucose reading chart will have its own Twitter account.
Apple’s HealtKit growing pains continue, as it is being forced to fix the platform over inaccurate blood glucose measurements. According to a CNet report, the problem came down to confusion over the metric system. HealthKit was designed to allow users to manually enter their blood glucose readings as measured in mg/dL (milligrams per decilitre), while users in the UK and Australia measure blood glucose levels in mmol/L (millimoles per litre). It would be easy to misinterpret the data if you didn’t notice the measurement distinction. Apple has promised to pull the feature with the next software update until it can be fixed.
Recalls vs. Enhancements
The FDA has made a lot of medical tech companies happy just by deleting a single sentence from its new rules on recalls. The offending sentence required medtech companies to report any product enhancements that would improve patient safety and user experience, even if the enhancements weren’t to correct a defect. According to a MassDevice report, medtech companies worried that they would be dinged in the court of public opinion if they had to report the enhancements in the same manner as defect recalls.
Novo Nordisk has announced it is investing in a new diabetes research center in the company’s native homeland of Denmark, according to a FierceBiotech report. The $130 million (U.S.) research center will be focused on “cutting-edge diabetes research within biotechnology and protein chemistry” that will benefit people with Type 1 and Type 2 diabetes, says the company’s chief science officer. Perhaps reflecting the practical spirit of the Danes, the new research facility will be called, simply, “Diabetes Research House”.
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