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FDA clears first glucose-monitoring system for mobile devices
Dexcom’s device doesn’t need a dedicated docking cradle; shares info with up to 5 ’followers’
January 26, 2015 |
The FDA has cleared the first glucose-monitoring system designed to be used with smartphones and other devices that can remotely track the health of a diabetic and ”share” the information with up to 5 additional ”followers.”
Dexcom’s ($DXCM) G4 Platinum Continuous Glucose Monitoring System with Share uses a small, wirelike sensor inserted underneath the skin to transmit data by a secure wireless connection using Bluetooth Low Energy (BLE) technology. That information can then be remotely tracked by up to 5 designated recipients without the need for a dedicated docking cradle, the company said in a press release.
Those ”followers” will be able to remotely monitor a patient’s glucose information and receive alert notifications from almost anywhere on their iPhones, and other devices.
”It will provide a huge improvement for people managing their diabetes and for those parents and caregivers who help them each and every day,” Kevin Sayer, Dexcom’s president and CEO, said in a statement.
The San Diego-based company’s apps related to the new device were cleared last Friday. The system itself was cleared today under the regulatory agency’s de novo process, which was created for low- to moderate-risk devices and doesn’t require the same rigorous review as more complicated products.
Although there are similar devices that have been developed, Dexcom’s is the first to be given the regulatory green light for U.S. sales since the FDA began regulating mobile medical applications as devices in 2013. According to the regulatory agency, there are an estimated 25.8 million people in the U.S. with diabetes, and about 215,000 of them are under the age of 20.
This is the first Dexcom system that is mobile compatible without the use of a docking system and is expected to be available by March, the company said.
From www.fiercemedicaldevices.com/
Press Release DexCom
FDA Approves Dexcom G4 Platinum Continuous Glucose Monitoring System with Share
Published: Jan 26, 2015 8:00 a.m. ET
Now people with diabetes as young as 2 years of age can automatically and securely share real-time CGM data from their Dexcom receiver to a caregiver’s mobile app
SAN DIEGO, Jan 26, 2015 (BUSINESS WIRE) — DexCom, Inc., DXCM, +8.22% a leader in continuous glucose monitoring (CGM) for patients with diabetes, announced today that it has received U.S. Food and Drug Administration (FDA) approval for its Dexcom G4® PLATINUM Continuous Glucose Monitoring System with Share. The Dexcom Share receiver uses a secure wireless connection via Bluetooth Low Energy (BLE) between a patient’s receiver and an app on the patient’s smartphone to transmit glucose information to apps on the mobile devices of up to five designated recipients, or “followers,” without the need for a dedicated docking cradle. These followers can remotely monitor a patient’s glucose information and receive alert notifications from almost anywhere, initially via their Apple® iPhone® or iPod® touch and in the future on Android devices, giving them peace of mind and reassurance when they are apart. The “Share” and “Follower” apps will be available on the Apple App Store at no charge.
“The Dexcom Share receiver represents a significant step forward for our company and our mobile strategy, but more importantly, it will provide a huge improvement for people managing their diabetes and for those parents and caregivers who help them each and every day,” said Kevin Sayer, President and Chief Executive Officer of Dexcom. “The FDA understands the importance of this type of innovation and the need to regulate it appropriately, and we could not be more pleased with the speed at which they reviewed and approved this important innovation.”
About Dexcom G4 Platinum with Share:
- The Share receiver is anticipated to ship to new patients in early March 2015.
- All patients who purchased a Share cradle will receive a free upgrade to the Share receiver.
- All purchasers of a G4 Platinum receiver from January 1, 2015, until the Share receiver is shipped, will receive a free upgrade to the Share receiver.
- There will be a low cost cash upgrade to the Share receiver for those patients who are still under warranty with their existing receiver.
- The Share receiver will be compatible with future generation Dexcom sensor systems.
About the De Novo Classification Process:
The FDA reviewed the mobile app software used with the Dexcom Share receiver (both the “Share” app on the patient’s phone and the “Follow” app on the caregiver’s phone) through its de novo classification process, a regulatory pathway for low- to moderate-risk medical devices that are novel and not substantially equivalent to any legally marketed device. The FDA has specifically classified the apps which communicate with the Share receiver as a secondary display device and has noted that similar devices which provide only secondary display for passive monitoring, but which do not replace the primary real-time display device, will be subject to the same classification, subject to compliance with certain special controls established by the Agency with respect to this secondary display. This means that devices which comply with appropriate FDA regulations, including the special controls, will not be required to submit a premarket notification to the FDA before marketing a secondary display device for continuous glucose monitoring. The Share receiver was still evaluated as a Class III medical device.
FDA News Release
FDA permits marketing of first system of mobile medical apps for continuous glucose monitoring
Data-sharing capability allows caregivers to monitor patient’s blood sugar levels remotely
For Immediate Release
January 23, 2015
Summary
The U.S. Food and Drug Administration today allowed marketing of the first set of mobile medical apps that allow people with diabetes to automatically and securely share data from a continuous glucose monitor (CGM) with other people in real-time using an Apple mobile device such as an iPhone.
Release
The U.S. Food and Drug Administration today allowed marketing of the first set of mobile medical apps that allow people with diabetes to automatically and securely share data from a continuous glucose monitor (CGM) with other people in real-time using an Apple mobile device such as an iPhone.
The Dexcom Share Direct Secondary Displays system’s data-sharing capability allows caregivers to a person with diabetes to monitor that individual’s blood sugar levels remotely through a legally marketed device that is available on mobile devices. Devices like the Dexcom Share were previously available through open source efforts, but were not in compliance with regulatory requirements. The Dexcom Share system is the first of its kind to offer a legally marketed solution for real-time remote monitoring of a patient’s CGM data.
“This innovative technology has been eagerly awaited by the diabetes community, especially caregivers of children with diabetes who want to monitor their glucose levels remotely,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Today’s marketing permission paves the way for similar technologies to be marketed in the United States.”
A CGM is a device that includes 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 (interstitial fluid). CGMs are worn externally and continuously display an estimate of blood glucose levels, and the direction and rate of change of these estimates. When used along with a blood glucose meter, CGM information can help people with diabetes detect when blood glucose values are approaching dangerously high and dangerously low levels.
The Dexcom Share system displays data from the G4 Platinum CGM System using two apps: one installed on the patient’s mobile device and one installed on the mobile device of another person. Using Dexcom Share’s mobile medical app, the user can designate people (“followers”) with whom to share their CGM data. The app receives real-time CGM data directly from the G4 Platinum System CGM receiver and transmits it to a Web-based storage location. The app of the “follower” can then download the CGM data and display it in real-time.
The FDA reviewed data for the Dexcom Share system through the de novo classification process, a regulatory pathway for low- to moderate-risk medical devices that are novel and not substantially equivalent to any legally marketed device. Data provided by the device maker showed the device functions as intended and transmits data accurately and securely.
Because the device is low to moderate risk, the FDA has classified the device as class II exempt from premarket submissions. In the future, manufacturers wishing to market devices like the Dexcom Share system will not need premarket clearance by the FDA prior to marketing, but they will still need to register and list their device with the agency, as well as follow other applicable laws and regulations.
“Exempting devices from premarket review is part of the FDA’s effort to ensure these products provide accurate and reliable results while still encouraging the development of devices that meet the needs of people living with diabetes and their caregivers,” said Gutierrez.
The Dexcom Share system does not replace real-time continuous glucose monitoring or standard home blood glucose monitoring. It is also not intended to be used by the patient in place of a primary display device. Additionally, CGM values alone are not approved to determine dosing of diabetes medications. CGMs must be calibrated by blood glucose meters, and treatment decisions, such as insulin dosing, should be based on readings from a blood glucose meter.
Diabetes is a serious, chronic metabolic condition where the body is unable to convert glucose into the energy needed to carry out daily activities. An estimated 25.8 million people in the U.S. – about 215,000 of them under age 20 – have diabetes. If left untreated, high blood glucose levels (hyperglycemia) can lead to serious long-term problems such as stroke, heart disease, and damage to the eyes, kidneys and nerves.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
From http://www.fda.gov
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