Overview
The Balloon Applicator is an accessory technology designed to enable targeted delivery of superficial radiotherapy to anatomical sites that benefit from conformable, tissue-contacting applicator geometry. Accurate placement and reproducibility are critical to clinical safety and efficacy.
Role
Supported the product and regulatory strategy for the Balloon Applicator technology at Sensus Healthcare, including design control documentation and integration with the existing 510(k) regulatory framework.
TODO(nick): confirm technical specifics, clearance, and outcomes.
Applicator DesignDesign Controls