T.H.E.M.
¨We believe in the judgment; we believe this first judgment will take place as God revealed, in America...¨
T.H.E.M.
¨We believe in justice for all, whether in God or not; we believe as others, that we are due equal justice as human beings.¨
U.S. regulator OKs first mobile apps system for glucose monitoring
Greetings,
U.S. regulator OKs first mobile apps system for glucose monitoring
The U.S. Food and Drug Administration (FDA) on Friday approved marketing of the first set of mobile medical apps that allow caregivers to remotely monitor diabetics’ blood sugar levels in real-time using mobile devices such as iPhones.
The device, known as the Dexcom Share Direct Secondary Displays system, is the first of its kind to offer a legally marketed solution for real-time remote monitoring of a patient’s continuous glucose monitor (CGM) data, the FDA said in a statement.
“Today’s marketing permission paves the way for similar technologies to be marketed in the United States,” said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
The system included a small, wire-like sensor inserted just under the skin that provides a steady stream of information about glucose levels in the fluid around the cells, or interstitial fluid.
It used two apps to display data: one installed on the patient’ s mobile device and one installed on another person’s mobile device, which was designated by the patient to share the CGM data in real time.
When used along with a blood glucose meter, it can help people with diabetes detect when blood glucose values are approaching dangerously high and dangerously low levels.
The FDA said data provided by the device maker, California- based Dexcom, showed the device functions as intended and transmits data accurately and securely.
In the future, manufacturers wishing to market devices like the Dexcom Share system will not need premarket clearance because such devices are of low to moderate risk, but they will still need to register and list their device with the agency, as well as follow other applicable laws and regulations, the FDA said.
The Dexcom Share system does not replace real-time continuous glucose monitoring or standard home blood glucose monitoring, the agency noted. The device is also not intended to be used by the patient in place of a primary display device.
Also, CGM values must be calibrated by blood glucose meters, and treatment decisions, such as insulin dosing, should be based on readings from a blood glucose meter. CGMs alone are not approved to determine dosing of diabetes medications, the FDA said.
Source: Xinhua
Click here for reuse options!Copyright 2015 Hiram's 1555 Blog