Proxima Clinical Research is excited to announce a Breakthrough Device Designation was granted for a novel medical device we work with!

Sigi™ provides a modern solution in the treatment of diabetes mellitus. It is the only insulin patch pump for closed loop integration designed for use with standard, pre-filled pump cartridges. Sigi™ can be programmed to deliver basal and bolus insulin at both set and variable rates via a Bluetooth-compatible continuous glucose monitors or alternative controller devices such as a smartphone or an iController.

“We would like to thank the FDA for recognizing our team’s proprietary, patient-focused technology, which provides users with enhanced clinical and convenience features.  This Breakthrough Device Designation will expedite the development of Sigi™ and prioritize its review in future FDA regulatory submissions.  It is a huge step forward in bringing Sigi™ to market to improve insulin management.”

Breakthrough Device Designation offers the opportunity to get lifesaving or life-improving medical devices out in the world where they can make a positive impact on a patient population in a quick and efficient manner. The submission process for BDD runs on a 60-day timeline.

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Want to learn more about AMF Medical’s Breakthrough Device Designation?

Click here to read more about AMF Medical’s Breakthrough Device Designation for their Sigi™ Insulin Management System.

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Are you interested in learning more about this designation?

To learn more about BDD and how Proxima Clinical Research can assist you in getting your product Breakthrough Device Designation, reach out to a regulatory specialist that can get your product on the path to market.