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.
Clearance
FDA 510(k) cleared (K190255).
Patent Application
Related intellectual property: US patent application US20200391052A1, Balloon applicator for directional intraoperative and brachy radiation therapy, filed 2020 by Sensus Healthcare. Nicolas Soro is a named inventor. The application was not granted.