March 1, 2021
Swiss pharma company Roche’s insulin pump will be the next to support automated insulin delivery thanks to a partnership with French AI company Diabeloop.
As part of the deal, users will be able to integrate Roche’s Accu-Chek Insights insulin pump with the Diabeloop monitoring system. This integration would result in a hybrid closed-loop system – a system designed to take the pressure off the...
January 2, 2020
On Apple and patents. A New York University School of Medicine cardiologist is unhappy with Apple Watch’s heart rate irregularity detection feature, which he claims in a new lawsuit infringes his own patent for atrial fibrillation detection technology. Filed in the US District Court for the Eastern District of New York on December 27, 2019, the suit describes Dr. Joseph Wiesel’s invention and his...
April 6, 2018
In the last quarter the FDA gave the nod to 10 digital health devices. Innovations that aimed to help diabetes management were popular, ranging from the first integrated continuous glucose monitor, which was put out by Dexcom, to Glooko’s insulin titration tool.
Not all FDA news this quarter was good news. In February Roche’s Accu-Check Connect Diabetes Management App was recalled by the FDA for...
February 16, 2017
Vienna and San Diego-based digital health company mySugr has come out of the International Conference on Advanced Technologies and Treatments for Diabetes with two big pieces of news: study results that show impressive efficacy of the app in high-risk populations and an expansion of its partnership with Roche.
The study looked at 440 mySugr users randomly selected from a group of high-risk (HbA1C...
March 17, 2011
According to a report from consulting firm Emergo Group, FDA officials said they would offer up guidance on how it plans to regulate mobile medical applications before the year is over. The report is not surprising considering the work that the mHealth Regulatory Coalition (mHRC) has done on the subject. Late last year the mHRC submitted its own guidance document for the FDA to consider as it...