RFID Breast Tumor Localization System

Project Goals

Health Beacons partnered with Sunrise Labs to help commercialize their RFID Breast Tumor Localization System prototype, a device to precisely locate RFID markers implanted at the site of nonpalpable breast lesions targeted for surgical removal. The device is designed to enable a more efficient process and a more accurate approach to tumor localization for breast surgeons. Additionally, it provides a more comfortable experience for patients versus the leading methods for marking breast tumors for removal.

Health Beacons sought to commercialize their RFID Breast Tumor Localization prototype, but needed to transform the prototype into a user-centric, tested and documented product for suitable regulatory clearances.

Sunrise Solution

Sunrise transformed a rudimentary functional prototype into a validated and verified medical device. The new device features a smaller housing unit with a more intuitive user interface. Obsolete components were removed and new processors, sensing coiling, and display was added. Sunrise was also responsible for testing and verification, creating device documentation for design history file to align with ISO-62304 and ISO-9000 processes and transfer to manufacturing.

Results

Sunrise's legacy electronics experience successfully evolved the existing prototype into a commercially viable product, complete with updated electronics and a more ergonomic look and feel. This product was successfully transferred to production. It received FDA clearance in April 2017 and will be marketed and distributed by Faxitron Bioptics, LLC.