US healthcare company receives FDA approval for Continuous Glucose Monitoring system
FDA approves Eversense CGM, making it the world’s first long-term implantable medical device for marketing in the US. The device will help people with diabetes in monitoring their glucose levels.
Sensonics, the medical technology company that focuses on the design and development on glucose monitoring systems, released a statement declaring the receipt of a Premarket Approval for the marketing of the Eversense Continuous Glucose Monitoring System (CGM) from the US Food and Drug Administration Board.
Tim Goodnow, the president and CEO of Senseonics said that they were very pleased to receive this FDA approval which would now enable the company to make Eversense available in the US markets. He said that with the development of several parallel trends of wearable medical devices, the Eversense comes as a natural evolution for diabetes devices.
The company believes that the new and unique features that Eversense has to offer will help aid millions of people with diabetes in monitoring their glucose levels. The Eversense system has successfully addressed many of the limitations that are associated with the use of CGM.
Healthcare professionals have believed that this new technology could help control blood glucose levels and hypoglycemia that is common among 70 percent of the diabetes patients.
Yet, this technology is grossly underused among thousands of patients who could benefit from Eversense and are ideal CGM candidates.
The system comes with fluorescence sensor, a transmitter that is worn over the sensor for communication of data and a mobile app that can be used to display the current glucose levels, send alters and display trends. The sensor’s insertion is done subcutaneously by the physician under the upper arm of the patient. The device is capable of providing continuous as well as long term monitoring for a period of around three months.
This ends the troubles of the patients for self-administering the insertions biweekly that are traditionally needed by other CGM systems.
The Eversense system’s small, smart transmitter is comfortable to wear and is discreet and very light weighted. The glucose values, trends and on-body vibratory alerts are sent to the mobile application via Bluetooth.
The PMA application for Eversense continuous glucose monitoring system included data from PRECISE II study of about 90 patients of ages 18 and older diagnosed with type 1 or type 2 diabetes. The test was conducted at 8 clinics across the United States that demonstrated the efficiency and safety of the device and its durability over the course of 90 days.
The results of the test showed that patients who had previously tried CGM either did not wear it often or do not stick with it for several reasons. This included uncertainty in the accuracy of the sensor, senor discomfort and insertion etc.
According to Steven Edelman, MD and Sensonics Board member, medical device companies that continue to do research and advance in the field of CGM should make it easier for the end users. He said the Eversense has clinically demonstrated its benefits with improved glucose levels among the test subjects and provided protection against severe Hypoglycemia.
Image credit: www.eversensediabetes.com