VISIOMED GROUP, a company specializing in new generation medical grade electronic products, is proud to announce that its first range of connected medical devices has been registered by the U.S. Food and Drug Administration (FDA). This major step now opens the way to marketing BewellConnect products on the vast North American continent.
To date, the BewellConnect range of flagship products have received the necessary approvals (especially FDA 510k) and can therefore be marketed in the United States. These are:
- MyGluco, blood sugar meter;
- MyGluco, range of essential 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 ThermoFlash¹
- MyScale Initial, weight scale;
- MyScale Analyser, body mass analyzer;
- MyScale XL 200kg, heavy weight scale;
- MyCoach, activity tracker and sleep
All these connected medical devices rolled out in the United States are linked to the BewellConnect interpretive medical platform that complies with HIPAA² / HITECH³ standards for privacy and the confidentiality of health data.
The other flagship 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.
The BewellConnect brand has enjoyed high media exposure in the United States since its participation at the Las Vegas CES in January 2015. The Group boosted its local involvement in July with the opening of its subsidiary BewellConnect Corp USA in Boston and its participation in September in the Best of France event in Times Square, New York.
¹ ThermoFlash contactless thermometer is also approved for sale in the United States.
² U.S. Health Insurance Portability and Accountability Act
³ U.S. Health Information Technology for Economic and Clinical Health Act