Lazarus Gets FDA 510(k) Clearance for Pre-Sure Surgical Technology
Lazarus 3D has received 510(k) marketing clearance from the FDA for its Pre-operative Surgical Rehearsal (Pre-Sure) technology.
The models are 3D-printed directly from patient imaging and CT scans to allow doctors to perform surgical rehearsals prior to surgery.
The clearance covers all genitourinary conditions, including conditions of the kidneys, prostate, bladder and genitalia.
The Pre-Sure models are created in synthetic, soft-tissue materials that can be cut and sutured, and can even “bleed,” according to the Albany, Ore.-based company.