SAN DIEGO, July 22, 2016 /PRNewswire/ -- DexCom, Inc.
(NASDAQ:DXCM), the leader in continuous glucose monitoring (CGM)
for patients with diabetes, announced today that the Clinical
Chemistry and Clinical Toxicology Devices Panel of the U.S. Food
and Drug Administration (FDA) voted in favor of the proposed
non-adjunctive indication for the DexCom G5 Mobile CGM system. This
indication would designate the G5 Mobile CGM system as a
replacement to fingerstick glucose testing for diabetes treatment
decisions.
Specifically, the panel voted:
- 8-2 supporting that there is reasonable assurance that the
DexCom G5 Mobile CGM system is safe for the proposed indications
for use,
- 9-1 supporting that there is reasonable assurance that the
DexCom G5 Mobile CGM system is effective for the proposed
indications for use, and
- 8-2 supporting that the benefits of the DexCom G5 Mobile CGM
system outweigh the risks for the proposed indications for
use.
"This recommendation is a big milestone for people with
diabetes," said Kevin Sayer, DexCom
President and Chief Executive Officer. "The diabetes community
turned out in force to support this decision. We commend the FDA
for bringing this important subject into a public forum, and thank
the panel members, as well as the public speakers for their
willingness to participate. We look forward to continued positive
discussions with the FDA as we seek the agency's approval of our
application."
Conference Call
DexCom management will hold a conference call to discuss the
meeting starting at 8:30 a.m. (Eastern
Time) today, Friday, July
22.
To listen to the conference call, please dial (888) 771-4371
(US/Canada) or (847) 585-4405
(International) and use the confirmation number "43019542"
approximately five minutes prior to the start time.
The conference call will be concurrently webcast. The link
to the webcast will be available on the DexCom, Inc. website
here.
About DexCom, Inc.
DexCom, Inc., headquartered in San Diego, CA, is dedicated to
helping people better manage their diabetes by developing and
marketing continuous glucose monitoring (CGM) products and tools
for adult and pediatric patients. With exceptional
performance, patient comfort and lifestyle flexibility at the heart
of its technology, users have consistently
ranked DexCom highest in customer satisfaction and
loyalty. For more information on the DexCom CGM,
visit www.dexcom.com.
CONSUMER CONTACT:
Caren Begun, 201-396-8551
INVESTOR CONTACT:
Steve Pacelli, 858-200-0200
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SOURCE DexCom, Inc.