Wednesday, August 02, 2023
Sirius Medical, a renowned leader in value-based healthcare and surgical marker navigation, received 510(k) clearance in early 2023 for their innovative Sirius Pintuition® Probe used during surgeries. This clearance allows users to resterilize the Pintuition® Probe using STERRAD NX and NX100 systems. The Pintuition system provides surgeons with accurate distance and direction information to locate non-palpable tumors, leading to improved diagnostic precision, reduced procedure times, and enhanced treatment planning for patients.
With the new FDA clearance, users gain the flexibility to choose between sterilizing the probe, sterilizing it and covering it with a sterile sheath, or utilizing only a sterile sheath, making the technology more accessible and convenient for surgical teams.
Bram Schermers, CEO of Sirius Medical, expressed the company's commitment to their customers, stating, "At Sirius Medical, we take pride in listening to our customers and continuously enhancing our products to deliver cost-efficient and improved patient care with ease of use. This FDA clearance aligns with our values of simplicity, flexibility, accessibility, and affordability."
Moreover, Sirius Medical recently announced a partnership with Surgeons Choice and Surgical Supplies, extending their surgical marker navigation technology to the Australian and New Zealand surgical communities, further advancing patient care in these regions.