U.S. Drug Administration First Approves Marketed Implantable Blood Glucose Monitoring Equipment
Medical Network June 25th The U.S. Food and Drug Administration approved for the first time on the 21st that a 'sensor fully implantable' glucose monitoring device will be available in the United States. This device can provide continuous blood glucose monitoring for adults with diabetes for up to 90 days. The device called 'Eversense Continuous Glucose Monitoring System' can be used for the continuous monitoring of blood glucose levels in diabetic patients over 18 years of age. The device uses a small sensor that can be completely subcutaneously implanted, and the implantation procedure can be operated at the outpatient clinic. 5 minutes to transfer blood glucose data to dedicated software in the phone.
According to a press release issued by the US Agency for Drug Control, fluorescent substances covered by the sensor emit weak light when they come in contact with blood glucose, causing the sensor to discriminate between too high or too low blood glucose levels.
US Department of Health Administrator Scott Gottlieb said that subcutaneous implants can help patients effectively manage diabetes and other chronic diseases. disease , Shows the potential of mobile devices.
The US Pharmacopoeia selected 125 adult patients with diabetes for a clinical study to evaluate the effectiveness and safety of the device. The number of people with serious side effects after implantation was less than 1%.