The U.S. Food and Drug Administration has registered the first range of connected medical devices from France’s Visiomed, which makes a variety of medical products, a key step that will allow the company to market its BewellConnect products in the North American continent.
“We obtained FDA registration of our first medical device this summer as planned, but wanted to wait to announce it until we had the major part of our product range authorized for sale in the United States,” said Eric Sebban, founding chairman and chief executive officer of Visiomed Group. “… On the strength of this authorization, our operations center in Boston, and our discussions under way with top-tier partners, we are convinced we will make BewellConnect the benchmark in connected health in the United States.”
The BewellConnect range of products have received the necessary approvals (especially FDA 510k) to be marketed in the United States. These are:
- MyGluco, blood sugar meter
- MyGluco, range of accessories (strips, sterile lances, control solution and lancing device)
- MyTensio, arm blood pressure monitor
- MyTensio, wrist blood pressure monitor
- MyThermo, thermometer with built-in patented contactless ThermoFlash technology.
- MyScale Initial, weight scale
- MyScale Analyser, body mass analyzer
- MyScale XL 200kg, heavy weight scale
- MyCoach, activity tracker and sleep analyzer
All of the connected medical devices rolled out in the United States are linked to the BewellConnect interpretive medical platform that complies with HIPAA and HITECH privacy standards for the confidentiality of health data.
The other products in the range, particularly MyECG, MyOxy and MyTens, are still in the process of registration. Visiomed Group expects them to be approved in the next few months.