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Dexcom's (DXCM) CGM Gets FDA's Breakthrough Device Designation

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DexCom, Inc. DXCM recently received the FDA’s Breakthrough Device Designation for the Dexcom continuous glucose monitoring (“CGM”) system’s use in the hospital setting. The designation is expected to offer a more efficient and streamlined review pathway to enable Dexcom CGM technology to faster expand the company’s footprint the hospital market.

With the latest regulatory recognition, Dexcom is expected to solidify its foothold in the global CGM business.

Significance of the Recognition

Dexcom CGM utilizes a small wearable sensor and transmitter that continuously measures and sends glucose levels wirelessly to a smart device. This enables the receipt of real-time glucose data without the need for fingersticks. This apart, the system also offers customizable alerts and alarms to aid in avoiding potentially dangerous low and high blood sugar events.

Per a medical personnel accustomed to the use of the Dexcom CGM in the hospital setting, the device was found to improve control over glucose levels without any increased risk in hypoglycemia (lower-than-normal blood sugar level). The receipt of the FDA’s Breakthrough Device Designation is likely to be transformative for using CGM for in-patient care in hospitals.

Per Dexcom’s management, the Dexcom CGM was allowed by the FDA for use in hospitals during the pandemic to help healthcare providers manage patient glucose levels. This usage demonstrated its potential as a better alternative to fingerstick blood glucose tests with greater quality of care and patient satisfaction.

Industry Prospects

Per a report by Grand View Research, the global CGM device market size was valued at $3,929.7 million in 2019 and is expected to reach $10.4 billion by 2027 at a CAGR of 12.7%. Factors like rising cases of diabetes and increasing adoption of CGM devices are likely to drive the market.

Given the market potential, the latest coverage announcement is expected to provide a significant boost to Dexcom’s business globally.

Notable Developments

Last month, Dexcom announced its fourth-quarter 2021 results, where it recorded robust uptick in the overall top line as well as across geographies. The company also confirmed submitting a comprehensive 510(k) pre-market notification to the FDA for regulatory review of the Dexcom G7 CGM System in accordance with the integrated CGM or iCGM Special Controls.

The same month, the company announced that diabetics under the age of 18 and requiring ongoing use of insulin or insulin pump therapy are eligible for public coverage of the Dexcom G6 CGM System through Alberta Health.

Price Performance

Shares of the company have gained 16.4% in the past year against the industry’s 1.4% fall. The S&P 500 has risen 13.6% in the same time frame.

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Zacks Rank & Key Picks

Currently, Dexcom carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space include Henry Schein, Inc. HSIC, Allscripts Healthcare Solutions, Inc. MDRX and AMN Healthcare Services, Inc. AMN.

Henry Schein, flaunting a Zacks Rank #1 (Strong Buy) at present, has an estimated long-term growth rate of 11.8%. HSIC’s earnings surpassed estimates in the trailing four quarters, the average beat being 25.5%. You can see the complete list of today’s Zacks #1 Rank stocks here.

Henry Schein has gained 39.4% compared with the industry’s 11.6% growth over the past year.

Allscripts has an estimated long-term growth rate of 16.3%. MDRX’s earnings surpassed estimates in the trailing four quarters, the average beat being 64.8%. It currently carries a Zacks Rank #2 (Buy).

Allscripts has gained 38.9% against the industry’s 47.7% fall over the past year.

AMN Healthcare has an estimated long-term growth rate of 16.2%. AMN’s earnings surpassed estimates in the trailing four quarters, the average beat being 20%. It currently sports a Zacks Rank #1.

AMN Healthcare has gained 47.6% against the industry’s 54.7% fall over the past year.


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