Key Benefits

We have received FDA 510(k) clearance to market software intended for use in radiation oncology, along with a CE Mark, TGA approval, and a quality management system (QMS) that complies with ISO 13485 requirements.

As a regulatory cleared solution, our software provides assurance that accessories are created as digitally designed and have been verified within the TPS. To maintain regulatory clearances, we follow strict QA/QC protocol so users are able to reduce risk compared to the manual creation of accessories.

Our software converts patient DICOM data into a digital model which can be printed, no matter the size or complexity.

RT accessories designed and customized in our software can be exported and verified in the TPS ensuring the accessory matches the prescribed treatment plan prior to printing.

Adaptiiv’s regulatory cleared software has been validated for use with various 3D printers and filament materials.*

We have spent over 10,000 hours establishing printer and material compatibility via a rigorous process validation procedure within Adaptiiv’s Quality Management System.

*If using a printer not compatible with Adaptiiv software, we work with you to ensure your printer meets the recommended minimum specifications to print RT accessories using our software.

Air gaps between standard sheet bolus and the patient surface can cause under dose in treatment. However, our 3D printing solution allows users to confidently create patient-specific accessories that significantly reduce air gaps, and spare healthy tissue compared to traditional methods.

Dose is calculated and verified using the latest modeling technology within the clinically commissioned TPS, ensuring that treatment is delivered as planned.

In complex cases that require modulated bolus, our solution improves the quality of electron plans that would otherwise be clinically unacceptable, ensuring patients receive the optimal treatment modality.

Patients can have peace of mind knowing that their bolus or applicator was created specifically for them based on their specific anatomy. Accessory design is completed in our software without the need for the patient to be present, if existing CT data is on file.

Patient-specific design results in a comfortable fit for even the most complex anatomy and eliminates the need for time consuming manual adjustments during treatment set up.