What does FDA clearance mean for Dexcom G7 15 Day?

The Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System is now cleared in the US for adults (18+) with all types of diabetes.

Dexcom G7 15 Day is cleared as an integrated continuous glucose monitoring system (iCGM) and is designed to last an industry leading^*,1 15.5 days^† (including a 12-hour grace period).

With FDA clearance, Dexcom G7 15 Day is on schedule to be released in the US the second half of 2025.

*Excludes implantable CGM systems

† A study was conducted to assess the sensor life where 73.9% of sensors lasted the full 15 days. When using the product per the package labeling, approximately 26% of sensors may not last for the full 15 days.

1 Dexcom, Data on File,2025

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Is your patient on a connected pump device?

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By submitting the above form, I certify that I am a licensed practitioner, authorized to receive and dispense samples of the Dexcom G6 Continuous Glucose Monitoring System and/or Dexcom‘s next generation product, Dexcom G7 (the "Samples"). I represent that I am requesting the Samples for evaluation purposes and that I will not (i) sell, resell, barter, return for credit or seek reimbursement for the use of the Samples, or (ii) for professional services for dispensing or evaluating the Samples, I also agree to inform my patients that they should not submit claims for reimbursement to any third party for any Samples.

The Samples are FDA cleared for use with a compatible smart device or separate piece of durable medical equipment called a receiver. Neither devices nor receivers are included in the Samples. Accordingly, and in light of the applicable G6 or G7 Dexcom Instructions for Use, you should dispense Samples only to a patient who (or whose authorized caregiver), in the exercise of your clinical judgment, (i) has reliable access to a compatible smart device and/or automated insulin delivery system, and (ii) is capable of safely using the Samples with their smart device, without the need for a separate dedicated receiver.

Please note that Medicare will reimburse for sensors only if the beneficiary also uses a receiver covered by Medicare. Accordingly, it is appropriate to give Samples to Medicare patients only if they have (in the case of the G6 Samples) or would be eligible to obtain (in the case of the G7 Samples), a Medicare-covered receiver.

You agree that you will not provide the Samples to any patients that are beneficiaries under the Maine or Colorado state Medicaid programs. I understand that Dexcom will be tracking, and if necessary, reporting and may be subject to disclosure requirements with respect to the provision of these Samples. I agree not to reuse any Samples. I acknowledge that Dexcom provides no warranties for the Samples other than the warranties outlined in the applicable Dexcom Instructions for Use. I will comply with all applicable federal, state and local laws in receiving and dispensing these Samples, and I agree to store and use these Samples in a manner consistent with the applicable Dexcom Instructions for Use. Dexcom is a registered trademark of Dexcom, Inc. in the United States and/or other countries. ©2023 Dexcom, Inc. All rights reserved.

LBL-1004145 Rev001

By submitting the above form, I certify that I am a licensed practitioner, authorized to receive and dispense these Dexcom G6 Continuous Glucose Monitoring Systems and/or Dexcom‘s next generation product, Dexcom G7 (the "Dexcom Education Devices") which are provided in the quantities listed above.

The Dexcom Education Devices are FDA cleared for use with a compatible smart device or separate piece of durable medical equipment called a receiver. Neither smart devices nor receivers are included with the Dexcom Education Devices. I understand that these Dexcom Education Devices are being requested for me and other healthcare professionals ("HCPs") for evaluation purposes to learn more about the Dexcom Education Devices and experience the benefits of the Dexcom Education Devices through a product demonstration, and that each HCP will need a compatible smart device for the product demonstration.

I acknowledge that Dexcom provides no warranties for the Dexcom Education Devices other than the warranties outlined in the applicable Dexcom Instructions for Use. I will comply with all applicable federal, state and local laws in receiving and dispensing these Dexcom Education Devices in a manner consistent with the applicable Dexcom Instructions for Use, and agree not to reuse any Dexcom Education Devices. I agree to receive, store, distribute, and/or use these Dexcom Education Devices in a manner consistent with the applicable Dexcom Instructions for Use and device labeling. I understand that Dexcom will be tracking, and if necessary, reporting and may be subject to disclosure requirements with respect to the provision of these Dexcom Education Devices. I understand and agree to properly dispose of the Dexcom Education Devices immediately following the completion of the product demonstration. The Dexcom Education Devices are being provided at no cost, without any expectation of remuneration, HCPs have no obligations under the federal supply schedule contract for participating in the product demonstration, and Dexcom waives any rights under this contract or applicable law to pursue a claim for the costs associated with the Dexcom Education Devices.

Dexcom is a registered trademark of Dexcom, Inc. in the United States and/or other countries. ©2023 Dexcom, Inc. All rights reserved.

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