SENS Stock Up as Eversense 365 CGM Wins European CE Mark Approval

Senseonics Holdings, Inc. SENS recently scored a meaningful regulatory win in Europe, receiving CE Mark approval for its Eversense 365 continuous glucose monitoring (CGM) system.

The approval builds on the U.S. launch momentum of Eversense 365, the world’s first one-year CGM, and reinforces the company’s differentiation in the global CGM market. With full ownership of commercialization and growing integration opportunities with automated insulin delivery systems, Senseonics is positioning itself for steady top-line growth across both U.S. and European markets.

Likely Trend of SENS Stock Following the News

Following the announcement, shares of the company gained 2.1% in yesterday’s trading session. However, in the last six-month period, SENS’s shares have lost 29% compared with the industry’s 21.8% decline. The S&P 500 increased 12.3% in the same time frame.

The European approval of Eversense 365 meaningfully strengthens SENS’ long-term growth outlook by expanding its addressable market and creating a new, multi-year revenue stream outside the United States. A one-year implantable CGM clearly differentiates Senseonics in a crowded CGM landscape, supporting better pricing power, stronger patient retention and recurring procedure-driven demand.

As adoption scales across major EU markets and partnerships with insulin pump makers deepen, this approval should enhance revenue visibility, improve operating leverage and reinforce SENS’ competitive positioning in the global diabetes technology market.

Meanwhile, SENS currently has a market capitalization of $278.7 million.

More on the Eversense 365 CGM System

Eversense 365 is designed to address some of the biggest pain points associated with traditional CGMs, starting with durability and reliability. It is the only CGM system with a full 365-day sensor, eliminating the need for frequent sensor changes and reducing the process to just one insertion, versus replacements every 10–14 days for short-term systems. The year-long sensor survivability also improves dependability, significantly reducing data gaps caused by sensor failures or routine changes. Since the tiny sensor sits securely under the skin, it cannot be accidentally knocked off, helping minimize wasted sensors, inconvenience and replacement costs for users.

Beyond longevity, the system emphasizes accuracy, comfort and flexibility, key drivers of long-term adoption. Eversense 365 delivers consistent accuracy over the full year with almost no false alerts from compression lows during sleep, increasing trust in glucose readings. Patient comfort is enhanced through a gentle, silicone-based adhesive that can be changed daily and causes minimal skin reactions.

The removable transmitter offers added freedom, allowing users to take it on and off without wasting a sensor or triggering a new warm-up period, while on-body vibration alerts ensure discreet notifications even when a phone is not nearby. Collectively, these features position Eversense 365 as a differentiated, patient-centric CGM solution with the potential to drive sustained adoption and engagement over time.

Favorable Industry Prospects for SENS

Per a report by Grand View Research, the global blood glucose monitoring devices market size was estimated at $15.53 billion in 2025 and is projected to reach $30.18 billion by 2033, expanding at a CAGR of 8.8% from 2026 to 2033.

The market is primarily influenced by the growing prevalence of diabetes and the increasing elderly population susceptible to conditions such as diabetes.

Other Recent Developments of SENS

Senseonics delivered a strong improvement in its third-quarter 2025 financial performance, with total revenue rising to $8.1 million from $4.3 million in the prior-year period, driven primarily by accelerating U.S. adoption. Also, U.S. revenue nearly tripled year over year to $6.4 million, reflecting improving commercial traction, while international revenue came in at $1.7 million, modestly lower than last year.

Importantly, the company reported a gross profit of $3.5 million in the quarter against a gross loss of $4.1 million a year ago, highlighting meaningful progress in cost structure, scale and overall operating efficiency.

SENS’s Zacks Rank & Stocks to Consider

SENS carries a Zacks Rank #3 (Hold) at present.

Some better-ranked stocks in the broader medical space are IDEXX Laboratories IDXX, Boston Scientific BSX and STERIS STE. Each stock presently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Estimates for IDEXX’s 2025 earnings per share (EPS) have remained constant at $12.93 in the past 30 days. Shares of the company have risen 12.6% in the past year compared with the industry’s 11.1% growth. IDXX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 7.1%. In the last reported quarter, it delivered an earnings surprise of 8.3%.  

Boston Scientific shares have gained 2.9% in the past year. Estimates for the company’s 2025 EPS have remained constant at $3.04 in the past 30 days. BSX’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 7.4%. In the last reported quarter, it posted an earnings surprise of 5.6%.

STERIS shares have risen 9.1% in the past year. Estimates for the company’s 2025 EPS have increased by 2 cents to $10.23 in the past 30 days. STE’s earnings topped estimates in three of the trailing four quarters and matched on one occasion, delivering an average surprise of 2.6%. In the last reported quarter, it posted an earnings surprise of 2.6%.

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