Mermaid Medical Group® Announces CE Marking for TP Pivot Pro™

Copenhagen, Denmark, January 2026

TP Pivot Pro™ Receives CE Marking
Mermaid Medical Group® is proud to announce that TP Pivot Pro™ has officially received CE marking, confirming compliance with the European Union’s health, safety, and environmental protection requirements. This milestone enables Mermaid Medical Group® to offer TP Pivot Pro™ to healthcare professionals across Europe, supporting the company’s continued expansion of innovative interventional solutions.

About TP Pivot Pro™
TP Pivot Pro™, developed by CIVCO Medical Solutions, is a needle guide designed for the minimally invasive, freehand transperineal approach to prostate biopsies. The device offers clinicians enhanced control and stability during targeted procedures, supporting both precision and patient safety.

Key features and benefits include:

• Fits all ultrasound probes, ensuring flexibility in clinical settings.
• Pivoting needle (±20°) for full prostate access and fewer punctures
• Five height settings, adjustable during procedures
• Single-use design for safety and efficiency
• Works with local or general anesthesia
• Lower risk of bleeding and infection

Leadership Perspectives
“It’s no secret that our team has been looking forward to this,” says Michael Kronby, Category Manager. “The CE marking means that we’re now able offer TP Pivot Pro to even more healthcare professionals across Europe, which is very exciting. It’s another step forward in our ongoing commitment to support better patient care.”

Last year, TP Pivot Pro received UKCA approval, and since then, Mermaid Medical has gained valuable insights from clinical partners in the UK. Marcus Kildegaard, Sales Director, reflects on the past year:
“The introduction of TP Pivot Pro™ in the UK has been a valuable and inspiring experience. We’ve met so many skilled clinicians, and their insights and feedback have been invaluable. These insights strengthen the way we enter the European market, making us better equipped than ever and genuinely excited to introduce TP Pivot Pro to even more healthcare professionals.”

Looking Ahead: European Launch and Collaboration
With CE marking now in place, Mermaid Medical is preparing for a full-scale European launch and looks forward to further collaboration with clinical partners across the region.

For more information, to request a demonstration, or to arrange a trial evaluation, please contact us.

Media Contact:
Anne Sandgaard
Mermaid Medical Group
+45 2194 8508 
asa@mermaidmedical.com