CE Mark Women's Health

Hologic wins CE mark approval for implantable tag

Hologic (NSDQ:HOLX) announced that it won an extension of the CE Mark approval for its LOCalizer radiofrequency identification (RFID) tag for long-term placement.

Under yesterday’s extension approval, the LOCalizer can now be implanted more than 30 days prior to a breast-conserving surgery to improve flexibility and convenience for both patients and providers.

The LOCalizer is a non-radioactive radiofrequency localization system designed for precise marking and targeting of lesions in breast-conserving surgery. Marlborough, Mass.-based Hologic said it is designed to replace the traditional wire-guided localization method, which requires day-of-surgery wire placement.

After early placement, Hologic’s tag can be detected on the day of surgery with a portable handheld reader that allows the surgeon to locate the correct area of breast tissue for removal. Each tag indicates the location and distance in millimeters to the lesion and features an identification number to improve workflow.

“The extension of LOCalizer’s CE Mark is yet another reflection of our commitment to continue to seek innovative solutions that create a more positive experience for both patients and physicians,” Hologic EMEA, Canada & Latin America regional president Jan Verstreken said in a news release. “It also represents another way we are working to improve breast health throughout the entire patient journey, including for complex breast conserving surgeries.”

Original Article: (https://www.massdevice.com/hologic-wins-ce-mark-approval-for-implantable-tag/)

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