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Sculptura

Medical-device program led from concept through development.

FDA 510(k) cleared · K182641

Overview

Sculptura is a medical-device program developed at Sensus Healthcare. Product leadership spanned the full development lifecycle, from early concept definition through design and development, while maintaining compliance with applicable medical-device regulations and quality system requirements.

Clearance

FDA 510(k) cleared (K182641).

Publication

The inverse treatment planning algorithm behind Sculptura was published in a peer-reviewed journal: Inverse treatment planning for an electronic brachytherapy system delivering anisotropic radiation therapy, Physics in Medicine & Biology, Vol. 66, No. 5 (2021). Nicolas Soro is a co-author.

Product DevelopmentSolidWorks