May 01, 2017
LOCalizer awarded 510k clearance by the FDA
Faxitron Announces LOCalizer™ Radiofrequency Identification System Granted FDA 510(k) Clearance for use in Breast Lesion Localization
Innovative technology enables precision and ease of use with a wireless Tag and Reader system that is free of radioactivity
Tucson, AZ. – April 28, 2017 – Faxitron, a 50-year leader in advancing technology for breast health today announced that the U.S. Food and Drug Administration (FDA) has granted clearance to LOCalizer™, a wireless radio frequency identification (RFID) breast lesion localization system manufactured by Health Beacons Inc. LOCalizer is a leading-edge, more precise technology for breast surgery guidance that has the potential to provide better outcomes for patients and their healthcare teams.
Traditional methods of locating non-palpable breast lesions for removal, such as procedures involving wire localization or radioactive seeds, are encumbered by complex regulations, potential scheduling conflicts, unintended wire migration, and added stress for patients. LOCalizer was designed to circumvent these complications by using a non-radioactive, proprietary Tag as a marker to enable the surgeon to remove the correct area of breast tissue during a procedure. The Tag can be implanted up to 30 days before surgery and is detected by a mobile, handheld Reader that accurately locates the Tag within millimeters.
“The most exciting aspect of the LOCalizer technology is being able to accurately measure the distance to the target lesion, something we haven’t been able to do with other localization methods,” says Dr. Christine Dauphine, MD, FACS, Director, Breast Clinic, Vice Chair, Surgical Education at Harbor-UCLA Medical Center. “Our team was able to experience the LOCalizer system first-hand in the operating room, and we were thrilled by the prospect of providing patients with a localization method that, by design, could avoid the anxiety of having additional procedures on the day of surgery.”
Several leading institutions, including UCLA, will be clinically evaluating LOCalizer to compare its benefits to other localization methods. “As the industry gets better at detecting smaller breast lesions, we must establish a new gold standard for breast lesion localization,” added Donogh O’Driscoll, CFO and COO of Faxitron. “LOCalizer could be the breakthrough needed to make lumpectomies and breast biopsies safer, more efficient and a better experience for both providers and patients. For more than half a century, our dedication to advancing breast health has been unwavering, and we’re honored to once again pave the way for a higher standard of care.”
For more information about LOCalizer, visit Faxitron at booth 506 at this year’s American Society of Breast Surgeons’ Annual Meeting in Las Vegas, April 26-30, 2017, or the company’s website at https://www.faxitron.com/product/localizer/.
LOCalizer is a wireless radio frequency identification (RFID) breast lesion localization system that uses the latest technology to help guide surgical removal of non-palpable lesions. The LOCalizer system includes a Tag Applicator, a miniature RFID Tag, a handheld Reader and a sterile Probe. The Tag is designed to be implanted in the lesion up to 30 days before surgery, and is free of radioactivity. The uniquely mobile handheld Reader contains an integrated Loop Probe that can be used directly on the skin to determine the location and distance to the lesion and plan the surgical path. During an operation, a single-use Surgical Probe can be used in small incisions to help guide the surgeon directly to the lesion.
About Faxitron® Bioptics, LLC
Faxitron is the industry leader in cabinet x-ray systems for specimen radiography, research, and NDT applications. For more than 50 years, Faxitron has defined cabinet x-ray by continuing to develop best in class x-ray sensor technology and innovative systems. In recent years, our product portfolio has expanded to include disposable medical equipment to meet the evolving needs of our customers. Faxitron has a global install base of over 8,000 systems and is present in all top 10 U.S. cancer centers. For more information, visit www.faxitron.com.