Sirius Medical obtains MDR CE-mark for Pintuition system | Alumni news (Venture Challenge Fall 2015)

Sirius Medical, alumnus of the Venture Challenge Fall 2015, has obtained MDR CE-marking for its Pintuition Surgical Marker Navigation System. The certification confirms that the system meets the latest requirements under the European Medical Device Regulation (MDR), one of the most stringent regulatory frameworks worldwide.

With this milestone, Sirius Medical is able to continue marketing its system in Europe under MDR compliance and further expand its clinical offering. The updated certification includes long-term implant status, probe re-sterilization options and the addition of a 7 cm needle for marker placement.

According to Sirius Medical, the MDR approval process was extensive and complex, requiring substantial regulatory preparation and documentation. Achieving MDR CE-mark allows the company to fully align its global portfolio and provide European customers with expanded clinical flexibility.

The long-term indication enables radiology teams to place the Pintuition marker at any time between biopsy and surgery, depending on patient and organisational needs. In combination with contrast-enhanced imaging modalities, this is expected to support optimized clinical workflows and improved patient experience.

The achievement represents an important regulatory and commercial milestone for Sirius Medical as it continues to strengthen its position in surgical navigation within the European MedTech landscape.

More information: https://lnkd.in/emmTcYSc

Source: LinkedIn