CE Mark Surgery

Hologic Renews Focus for Breast Health with CE Mark Extension

Hologic is wasting little time putting the focus back on its breast health offerings. The Marlborough, MA-based company received an extension of a CE mark for the LOCalizer radiofrequency identification (RFID) tag for long-term placement.

The tag can now be implanted more than 30 days before a breast-conserving surgery, providing even greater flexibility and convenience to patients and providers.

The LOCalizer wire-free guidance system is a non-radioactive, radiofrequency localization system designed for precise marking and targeting of lesions in breast-conserving surgery. It was designed to replace the traditional wire-guided localization method, which requires placement of a wire on the day of surgery. With this new tag, placement can be done weeks or months before surgery. For patients, this means they can arrive closer to their surgery time and experience fewer interventional procedures.

“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,” Jan Verstreken, Hologic’s Regional President, EMEA, Canada & LatAm, said in a release. “It also represents another way we are working to improve breast health throughout the entire patient journey, including for complex breast-conserving surgeries.”

The LOCalizer system is manufactured by Health Beacons and is exclusively distributed by Hologic. The distribution rights were inherited from Hologic’s acquisition of Faxitron Bioptics for $85 million in August of 2018.

The CE mark extension can be seen as Hologic standing strong on its commitment to put the emphasis back on its breast imaging and health offerings. A few weeks before the extension, Hologic announced it was divesting the Cynosure medical aesthetics company for $205 million to an affiliate of investment funds managed by Clayton, Dubilier & Rice. Cynosure was originally acquired by Hologic for $1.65 billion. However, the medical aesthetics company had consistently under-performed for Hologic.


Original Article: (https://www.mddionline.com/hologic-renews-focus-breast-health-ce-mark-extension)