Yahoo Finance Stereotaxis (STXS) Gets CE Recertification for Approved Products
Stereotaxis STXS a pioneer in surgical robotics for minimally invasive endovascular intervention, recently announced its successful recertification under the European Union’s Medical Device Regulation (MDR).
This significant milestone, which covers all Stereotaxis devices currently available in Europe, marks a crucial advancement in the company's pursuit of excellence in the surgical robotics market.
The News in Detail
The MDR (Regulation (EU) 2017/745) replaces the previous European Medical Device Directive, setting more stringent standards and requirements across quality, clinical, and post-market surveillance areas. The new regulatory framework aims to enhance clinical safety and ensure robust market access for medical devices within the European Union.
Stereotaxis' achievement in receiving the updated EU Quality Management System Certificate, demonstrating compliance with MDR, underscores the company’s commitment to high standards and rigorous quality assurance.
Enhancing Market Competitiveness
With the MDR certification, Stereotaxis not only secures its current product lineup but also strengthens its position for future innovations. This certification is pivotal for regulatory clearances of upcoming advancements, ensuring that new products meet the enhanced safety and performance standards.
By adhering to stringent regulatory requirements, Stereotaxis not only enhances its market credibility but also paves the way for expanded access to minimally invasive therapies. This achievement is set to propel the company further in the surgical robotics market, ensuring precision, safety and enhanced operational productivity.
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Market Prospects
According to a Future Market Insights report, the robotic-assisted endovascular systems market is poised for substantial growth, with its size projected to rise from $94 million in 2023 to $214.7 million by 2033, at a CAGR of 8.6%. This market involves the use of robotic technology in minimally invasive procedures to treat cardiovascular and vascular disorders. Key drivers include the rising prevalence of these conditions, advancements in robotic technology enhancing system capabilities and increased surgeon awareness of the benefits, leading to improved efficiency and patient outcomes in endovascular treatments.
Price Performance
Year to date, shares of STXS have gained 13.2% compared with the industry’s 8.2% rise.
Zacks Rank and Key Picks
Stereotaxis carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are Hims & Hers Health HIMS, Medpace MEDP and ResMed RMD. While Hims & Hers Health and Medpace each sport a Zacks Rank #1 (Strong Buy), ResMed carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks Rank #1 stocks here.
Hims & Hers Heath stock has surged 75.3% in the past year. Estimates for the company’s earnings have risen from 10 cents to 18 cents for 2024 and from 23 cents to 32 cents for 2025 in the past 30 days.
HIMS’ earnings beat estimates in three of the trailing four quarters and missed in one, delivering an average surprise of 79.2%. In the last reported quarter, it posted an earnings surprise of a staggering 150%.
Estimates for Medpace’s 2024 earnings per share have moved up to $11.29 from $10.80 in the past 30 days. Shares of the company have surged 93.2% in the past year compared with the industry’s 8.7% growth.
MEDP’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 12.8%. In the last reported quarter, it delivered an average earnings surprise of 30.6%.
Estimates for ResMed’s fiscal 2024 earnings per share have moved to $7.64 from $7.43 in the past 30 days. Shares of the company have declined 2.4% in the past year against the industry’s rise of 4.8%.
RMD’s earnings surpassed estimates in three of the trailing four quarters and missed in one, the average surprise being 2.8%. In the last reported quarter, it delivered an earnings surprise of 10.9%.
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