Sirius Medical Achieves MDR Certification and Expanded Indications for Pintuition® Surgical Marker Navigation

Written by Sirius Medical | Jan 19, 2026

Eindhoven, the Netherlands – January 19, 2026 – Sirius Medical, the leader in surgical marker navigation, proudly announces that its Pintuition^® Surgical Marker Navigation System has achieved MDR CE-mark, the most stringent regulatory standard in the world. This milestone underscores Sirius Medical’s commitment to meeting the highest safety and performance requirements set by the European Commission.

With MDR CE-mark, Pintuition now includes significant product upgrades and updated indications, which are currently already available in the US:

Long-term implant status – enabling surgeons to place the marker at time of biopsy, offering greater flexibility and patient-centered planning.
Probe re-sterilization – now providing multiple options for reprocessing, reducing barriers to access and improving cost-efficiency.
7 cm needle – a shorter needle variant, further broadening clinical use.

“We are extremely proud to have achieved MDR CE-mark, the most rigorous regulatory environment globally,” said Bram Schermers, CEO of Sirius Medical. “This milestone reflects our commitment to simplifying and enhancing the surgical journey for physicians and patients alike.”

Pintuition, enhanced by TargetLOC^® technology, provides surgeons with precise distance and directional guidance to non-palpable tumors.

“The new long-term indication for Pintuition gives radiology teams full flexibility to place Pintuition at any time from biopsy to surgery, depending on patient needs and organizational requirements. Combined with contrast-enhanced imaging modalities, this is expected to further optimize clinical workflows and enhance the overall patient experience,” said Corinne Balleyguier, Head of the Imaging Division at Gustave Roussy.

With MDR CE-mark secured, Sirius Medical is positioned to expand its global footprint and deliver simple, precise, and accessible surgical marker navigation solutions that empower clinicians and improve patient care.

About Sirius Medical

With its roots deeply embedded in the Netherlands Cancer Institute, Sirius Medical is dedicated to improving care for cancer patients by delivering unsurpassed yet affordable solutions that enable precise and efficient removal of tumors. Sirius Medical is rapidly expanding with over 70,000 procedures worldwide in more than 250+ centers and a global commercial network covering the USA, Western and Central Europe, Australia, and New Zealand.

Media Contact:

Benjamin Tchang
Marketing Director
Sirius Medical
+31 647 852 805
Benjamin.tchang@sirius-medical.com

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