FDA Approves Dexcom G4 Platinum Continuous Glucose Monitoring System with Share
January 26 2015 - 8:00AM
Business Wire
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
DexCom, Inc., (NASDAQ:DXCM), 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.
Management will hold a conference call to review this approval
starting at 9:00 a.m. (Eastern Time) on Monday, January 26, 2015.
The conference call will be concurrently webcast. The link to the
webcast will be available on the Dexcom website at www.dexcom.com
by navigating to “Our Company,” then “Investor Relations,” and then
“Events and Webcasts,” and will be archived there for future
reference.
To listen to the conference call, please dial (888) 771-4371
(US/Canada) or (847) 585-4405 (International) and use the
confirmation number 38877953 approximately five minutes prior to
the start time.
About DexCom, Inc.
DexCom, Inc., headquartered in San Diego, California, is
developing and marketing continuous glucose monitoring systems for
ambulatory use by people with diabetes and by healthcare providers
in the hospital.
DexCom, Inc.Steven R. Pacelli, 858-200-0200Executive Vice
President, Strategy and Corporate Development
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