Stereotaxis STXS recently submitted an application seeking FDA regulatory clearance for its MAGiC Sweep catheter, which is the first-ever robotically navigated high-density electrophysiology (EP) mapping catheter. This submission marks a significant advancement in integrating Robotic Magnetic Navigation (RMN) technology with high-density mapping, aiming to enhance the precision and safety of cardiac arrhythmia treatments.

With this regulatory submission, Stereotaxis is taking a critical step toward strengthening its proprietary robotic catheter portfolio and addressing longstanding limitations in robotic EP procedures. The company anticipates regulatory approval in the second half of 2025, paving the way for a broad commercial launch.

Likely Trend of STXS Stock Following the News

Following the announcement, shares of the company plunged 6.8% and closed at $1.81 on Thursday. In the past six months, STXS shares have lost 14.2% compared with the industry’s 2.6% decline. The S&P 500 increased 8.7% in the same time frame.

However, if approved, the MAGiC Sweep catheter could boost STXS stock price in the long run as it positions Stereotaxis as a more competitive player in the growing field of robotic-assisted medical procedures. Currently, one of the biggest challenges in robotic EP procedures is the lack of compatible high-density mapping catheters, which are essential for accurately identifying arrhythmia locations in the heart.

By introducing the first-ever robotically navigated high-density EP mapping catheter, STXS not only solves this gap but also makes its robotic system more attractive to hospitals and doctors. This innovation could lead to wider adoption of Stereotaxis' robotic technology, driving higher demand for both its robotic systems and disposable catheters, which would generate recurring revenue.

Meanwhile, STXS currently has a market capitalization of $174.5 million.

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More on the STXS’ MAGiC Sweep Catheter

The MAGiC Sweep catheter is specifically designed to work with Stereotaxis RMN systems, combining the precision of robotics with the advanced capabilities of high-density electroanatomical mapping. The catheter is equipped with 20 electrodes that simultaneously collect electrical signals from the heart, allowing for faster, more detailed, and more accurate identification of arrhythmia origins compared to traditional point-by-point mapping methods.

The introduction of MAGiC Sweep addresses one of the key limitations in robotic EP procedures, where the absence of compatible high-density mapping catheters has slowed the widespread adoption of robotic navigation systems. The catheter's design allows it to reach difficult areas of the heart more safely without causing trauma to tissue and provides more anatomically accurate maps by avoiding the pressure or distortion often caused by rigid catheters. The device is expected to improve procedural workflow by enabling automated mapping, further enhancing the efficiency and safety of robotic EP interventions.

Stereotaxis designed and manufactured the MAGiC Sweep catheter through its fully-owned subsidiary, Access Point Technologies, which the company acquired to strengthen its proprietary catheter portfolio. Stereotaxis submitted a 510(k) application for MAGiC Sweep with the FDA and expects to submit MAGiC Sweep for European CE Mark clearance this month. The company expects regulatory approvals in the second half of 2025, with plans for a broad commercial launch shortly after.

STXS’ Favorable Industry Prospects

Per a report by Future Market Insights, the global market for robotic catheterization systems is estimated to be worth $54.4 million in 2025 and is anticipated to reach $190.2 million by 2035.

The growing demand for minimally invasive procedures is a key driver for the robotic catheterization systems market. With patients and healthcare providers prioritizing faster recovery, lower complication risks, and cost-effective treatments, minimally invasive surgeries are becoming the preferred option.

STXS’s Zacks Rank & Stocks to Consider

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

Some better-ranked stocks in the broader medical space are Masimo MASI, Boston Scientific BSX and Cardinal Health CAH. At present, Masimo sports a Zacks Rank #1 (Strong Buy), whereas Boston Scientific and Cardinal Health carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Masimo’s shares have rallied 30.1% in the past year. Estimates for MASI’s 2024 earnings per share (EPS) have increased 1.2% to $4.10 in the past 30 days. MASI’s earnings beat estimates in each of the trailing four quarters, the average surprise being 17.1%. In the last reported quarter, it posted an earnings surprise of 16.6%.

Estimates for Boston Scientific’s 2025 EPS have jumped 2.9% to $2.85 in the past 30 days. Shares of the company have surged 56.7% in the past year compared with the industry’s growth of 12.5%. BSX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 8.25%. In the last reported quarter, it delivered an earnings surprise of 7.69%.

Estimates for Cardinal Health’s fiscal 2025 EPS have increased 1.5% to $7.94 in the past 30 days. Shares of the company have gained 15.2% in the past year against the industry’s 4.1% decline. CAH’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 9.6%. In the last reported quarter, it delivered an earnings surprise of 10.3%.

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

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