DXCM Stock Falls Despite FDA Clearance for Dexcom Smart Basal

DexCom DXCM recently announced that it has received FDA clearance for its CGM-integrated basal insulin dosing optimizer, Dexcom Smart Basal, for use by adults with Type 2 diabetes on glargine U-100 long-acting insulin therapy. The Dexcom Smart Basal is the first and only titration software module that integrates with a CGM sensor to optimize basal insulin doses.

The FDA-cleared software feature will use data from DexCom’s latest CGM sensor, G7 15 day, and logged doses to calculate personalized daily recommendations. This optimization is likely to guide users toward a more effective long-acting insulin dose, as directed by their healthcare provider.

DexCom Smart Basal is also under review in Europe.

Share Price Performance

Despite receiving FDA clearance for Dexcom Smart Basal, the stock continued its slide and declined 0.7% on Nov. 19, following the news, primarily due to ongoing pressure on gross margin. DXCM stock has lost 23.2% so far this year against the industry’s growth of 0.6%. The S&P 500 has gained 13.5% in the same period.

Although the stock continued to slide despite the FDA clearance, the new software feature will likely strengthen demand for the G7 15 day sensor in the type 2 diabetes basal-insulin population.

More on DexCom Smart Basal Insulin

Basal insulin is primarily used to maintain stable blood glucose level during periods of fasting, like sleeping. However, there is apprehension regarding its usage among type 2 diabetes patients due to fears of hypoglycemia. Moreover, it takes several months to reach an optimal dose of basal insulin through trial and error while using traditional methods.

Dexcom Smart Basal starts with an initial basal insulin dose set by healthcare provider and sends daily dose recommendations and reminders on the G7 15 Day app. The titration software module analyzes all of a user’s CGM readings to provide personalized insulin dose recommendations, rather than relying on a single fasting blood glucose measurement.

The software feature will set an optimal dose for the user when glucose is consistently within the set target range. Dexcom Smart Basal reduces the user’s healthcare provider-recommended insulin dose in the event of low glucose and offers customizable low alerts that provide proactive protection against hypoglycemic episodes.

DexCom believes that integrating DexCom Smart basal software feature with G7 15 day sensor is likely to improve adherence and greatly reduce the required workflow for the prescribing community by removing manual input and frequent office visits.

Please note that DexCom received FDA clearance for G7 15 day sensor in April 2025 and is likely to launch the device in U.S. market by year-end. DexCom Smart Basal feature will be available to type 2 diabetes patients shortly after the launch of the G7 15 day sensor.

DexCom, Inc. Price

DexCom, Inc. price | DexCom, Inc. Quote

DXCM’s Zacks Rank & Stocks to Consider

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

Some better-ranked stocks from the broader medical space are Medpace Holdings MEDP, Globus Medical GMED and Masimo MASI.

Medpace, currently sporting a Zacks Rank #1 (Strong Buy), reported a third-quarter 2025 EPS of $3.86, which surpassed the Zacks Consensus Estimate by 10.29%. Revenues of $659.9 million beat the Zacks Consensus Estimate by 3.04%.You can see the complete list of today’s Zacks #1 Rank stocks here.

MEDP has an estimated earnings growth rate of 17.1% for 2025 compared with the industry’s 16.6% growth. The company beat on earnings in each of the trailing four quarters, the average surprise being 14.28%.

Globus Medical, sporting a Zacks Rank of 1 at present, posted a third-quarter 2025 adjusted EPS of $1.18, which exceeded the Zacks Consensus Estimate by 49.4%. Revenues of $769 million topped the Zacks Consensus Estimate by 4.9%.

GMED has an estimated long-term earnings growth rate of 14.3% compared with the industry’s 12.7% growth. The company’s earnings outpaced estimates in three of the trailing four quarters and missed once, the average surprise being 16.24%.

Masimo, currently carrying a Zacks Rank #2 (Buy), reported a third-quarter 2025 adjusted EPS of $1.32, which surpassed the Zacks Consensus Estimate by 10.9%. Revenues of $372 million outperformed the Zacks Consensus Estimate by 1.3%.

MASI has an estimated long-term earnings growth rate of 15.9% compared with the industry’s 12.7% growth. The company’s earnings beat estimates in each of the trailing four quarters, the average surprise being 12.39%.

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

This article originally published on Zacks Investment Research (zacks.com).

Zacks Investment Research