Senseonics, makers of the first continuous glucose monitoring system with a fully implantable glucose sensor and compatible mobile app for adults with diabetes, recently recalled their devices approximately 1 year after FDA approval. The recall was a result of a manufacturing process error in one specific manufacturer, and only this manufacturer and patients, physicians, and distributors connected with this manufacturer were affected by this recall. This process started with the health hazard evaluation and recall classification. A recall strategy is determined and implemented. The FDA, in response of the recall, will monitor recalls and assess the adequacy of a firm's efforts during the process. A public safety alert is released, detailing the product affected and reason for recall. Status reports are released during the recall process, until the recall is terminated when the device has either been removed or corrected in accordance with the FDA.
I am going to talk about few apps that connect to the glucometer without wire.
1. BG Monitor Diabetes : It is an app that logs everything at one spot. It tracks blood glucose, insulin and carb intake. If target numbers are put, the app automatically calculates insulin.
2. Glucose Buddy : It connects to Dextom glucometer. It also allows to log numbers automatically while taking steps, exercise and meals.
3. Diabetes M : It is a diabetes log app. It reminds test time, a nutritional log and tracking system, integrations with fitness apps and blood sugar trend mapping. This app also calculates insulin bolus based on the nutritional value. The subscription service of this app allows to have multiple profiles.
These are few of the many apps that helps in blood sugar measuring.
An example of an FDA approved medical device using a mobile app is shown here
https://www.medicalbag.com/home/more/tech-talk/fda-approves-first-mobile-app-for-use-in-preventing-pregnancy/
The article sites efficacy statistics but not safety since there are no safety risks associated with this app.
Here is a key term used to describe medical devices in relation to software that is been given by the FDA illustrated in the following phrase: FDA refers to software functions that are device functions as "device software functions." Device software functions may include "Software as a Medical Device (SaMD)"
I think this is a interesting notion where software is denoted as a medical device. Whats useful about this document is it explains the approach the FDA is taking to provide guidance on the burgeoning software medical device realizations coming online. What is specified is not limited to mobile device usage but rather a framework for including software in medical devices in general regardless of he platform:
At least four scenarios follow from this:
1) Software which serves in it own right as a standalone medical services
2) Software in a medical device such as that included in medical equipment
3) Software as an accessory to a medical device
4) General purpose software that is not a medical product by itself.
