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