Mass.-based medical device company Insulet issued a notice of a data breach that may have compromised the protected health information of 29,000 users of its recently recalled Omnipod DASH Insulin Management System.
In November, the FDA posted a notice about a Class I recall of Insulet's Omnipod DASH Insulin Management System Personal Diabetes Manager, following complaints about the battery,...
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...
The FDA has issued a class two device recall for Senseonics’ Eversense continuous glucose monitoring system. This posting follows a September notice from the company that alerted providers and distributors in the US that the sensors of certain devices may stop working prematurely.
Senseonics identified a small number of Eversense Sensors that have prematurely stopped functioning due to inadequate...
In early August, the FDA issued a Class 2 Device Recall for Visibly’s Online Refraction Vision Test, stating that the company did not receive authorization from the FDA to market the product. According to the recall, Visibly has already initiated the recall.
This back and forth between the Chicago-based startup (formerly known as Opternative) and the FDA has been going on for a couple of years....
In March, Roche received FDA clearance for its Accu-Chek Connect companion app, and, less than a month later, issued a recall of that app. App recalls, which are becoming more common as more and more apps receive FDA clearance, are less severe than device recalls because they can often be ameliorated with a quick software patch.
The app, available only on Android at present, helps patients track...
