We’re proud to announce that on February 27, 2025, Xaga Surgical’s Forsvall Biopsy
System received FDA 510(k) clearance. This clearance confirms the system’s
substantial equivalence to predicate devices for prostate biopsy and marks a major
milestone in our mission to improve patient safety. The Forsvall Biopsy System is
designed to reduce bacterial transfer during procedures, lowering infection risks
while enhancing diagnostic precision. We’re excited to take this next step toward
bringing safer, more effective biopsy solutions to healthcare providers and patients in
the U.S. and beyond.
Xaga Surgical’s Forsvall Biopsy System Receives FDA 510(k) Clearance
