DexCom Granted FDA Breakthrough Designation for Hospital CGM System

DexCom, Inc. (NASDAQ: DXCM) has been granted Breakthrough Device Designation (BDD) by the U.S. Food and Drug Administration (FDA) for its Dexcom Hospital continuous glucose monitoring (CGM) System. The company is engaged in the development, manufacture, and distribution of continuous glucose monitoring systems for diabetes management. 

The device is designed for more effective glycemic management and improved patient outcomes in the hospital setting. The small, wearable sensor and transmitter in Dexcom CGM consistently measure and send glucose levels wirelessly to a smart device. The device provides real-time glucose data without fingersticks. Additionally, customizable alerts and alarms are present in the system, which aids in avoiding significant dangerous low and high blood sugar events. 

Obtaining BDD gives medical devices a faster track to regulatory review. 

Official Comments 

M.D., endocrinologist and corporate VP for the Scripps Whittier Diabetes Institute in San Diego, Athena Philis-Tsimikas, said, “In our extensive use of Dexcom CGM in our hospitals as part of exploratory studies over the last seven years, more than 800 of those patients treated during the pandemic, we have found that the device improves glucose control without any increased risk in hypoglycemia. Breakthrough Device Designation from the FDA could be transformative for using CGM for in-patient care in hospitals.” 

Wall Street’s Take 

Recently, Cowen & Co. analyst Joshua Jennings maintained a Buy rating on the stock but lowered the price target to $553 (35.4% upside potential) from $655. 

Consensus among analysts is a Strong Buy based on 11 Buys versus 1 Hold. The average DexCom price target of $568.75 implies 39.26% upside potential from current levels. Shares have gained 4.2% over the past year. 

Investors 

TipRanks’ Stock Investors tool shows that investors currently have a Very Positive stance on DexCom, with 17.3% of investors maintaining portfolios on TipRanks increasing their exposure to DXCM stock over the past 30 days. 

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