RFID Breast Tumor Localization System

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

 
  • Developed prototype into a validated and verified medical device
  • Designed a more intuitive user interface and ergonomic look and feel
  • Removed obsolete components and added new processors, sensing coiling, and display
  • Performed testing and verification, for DHF to align with Iec-62304 and ISO-9000 processes and transfer to manufacturing
  • Transferred to manufacturing and supported production ramp up for capital and consumable 
  • Received FDA clearance in April 2017
  • Acquired by Hologic in 2020
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