Kallisio Receives CE Mark for Stentra™ Precision Oral Immobilization System
Kallisio, a company focused on advancing precision oncology through patient-specific, technology-enabled solutions, today announced CE certification under the European Union Medical Device Regulation (EU MDR 2017/745) for its Stentra intraoral positioning system. This certification enables commercialization within the European Economic Area, with initial deployment planned in Germany through selected clinical pilot sites.
Kallisio Announces Clinical Implementation of Its Patient-Specific Stentra™ System
Kallisio, a company developing patient-specific precision-therapy solutions, announced that it has collaborated with Stanford Health Care to support the clinical implementation of its FDA-cleared Stentra system for use in head and neck cancer radiation therapy.
Kallisio Patient-tailored Oral Stent for Head and Neck Cancer (HNC) Treatment Receives FDA Clearance
Kallisio, focused on developing solutions to manage toxicity in cancer care, announces FDA 510(k) clearance for Stentra, an individually tailored 3D printed oral stent solution designed to protect healthy tissue in Head and Neck Cancer (HNC) patients. Customized for each patient, the Stentra oral immobilization stent effectively directs radiation to the target tumor area while reducing harmful impact to surrounding tissue.
