Sirius Medical, a leader in value-based healthcare and surgical marker navigation received 510(k) clearance early in 2023 for their Sirius Pintuition® Probe, used during surgery, to be resterilized by users in STERRAD NX and NX100 systems.
Pintuition is a surgical marker navigation system that provides surgeons with both distance and direction to non-palpable tumors with exceptional accuracy. Patients benefit from enhanced diagnostic accuracy, reduced procedure times, and improved treatment planning.
Users now have the flexibility to choose either to only sterilize, sterilize and cover with a sterile sheath or only use a sterile sheath when using the Pintuition Probe, further broadening the acceptability of the technology and lowering access barriers.
“This FDA clearance is in line with the values we are bringing to our customers worldwide, simplicity, flexibility and accessibility, and affordability,” says Bram Schermers, CEO Sirius Medical. “At Sirius Medical we take pride in listening to our customers bringing continuous product enhancement to help deliver cost-efficient and better patient care with ease of use.”
The company also recently announced their partnership with Surgeons Choice and Surgical Supplies to provide the Australian and New Zealand surgical communities with surgical marker navigation.