January 21, 2019 – Hologic announced that the U.S. Food and Drug Administration (FDA) has cleared the LOCalizer radiofrequency identification (RFID) marker for long-term placement. With this clearance, the marker can now be implanted more than 30 days prior to a breast-conserving surgery, providing even greater flexibility and convenience to patients and providers.
Initially cleared by the FDA in 2017, LOCalizer is a non-radioactive, radiofrequency localization system designed for precise marking and targeting of lesions in breast-conserving surgery. The system was designed to replace the traditional wire-guided localization method, which requires placement of a wire the day of surgery. It is manufactured by Health Beacons Inc. and is exclusively distributed by Hologic.
Following placement days ahead of surgery, the miniature implantable tag can be detected by a portable, handheld reader that indicates the location and distance to the lesion, enabling the surgeon to pinpoint the correct area of breast tissue for removal. Each tag also features a unique identification number that is displayed on the reader. This improved workflow is designed to help reduce scheduling and logistical hurdles for care teams, and aims to deliver added convenience for an enhanced patient experience.
Dona Hobart, M.D., breast surgeon and medical director of the Center for Breast Health at Carroll Hospital in Maryland, has been using the LOCalizer system for almost a year. “The LOCalizer system is designed to address the challenges of other localization methods as well as enable surgeries tailored appropriately to each patient, which is a positive advancement in patient care,” she said.
For more information: www.hologic.com