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 Labs Solution
- Developed prototype into a validated and verified medical device
- Designed a more intuitive user interface
- Obsolete components were removed and new processors, sensing coiling, and display was added
- Responsible for testing and verification, for DHF to align with ISO-62304 and ISO-9000 processes and transfer to manufacturing
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.