Close look into US FDA 510(k) clearance – Adaptiiv’s 3D Bolus Software

Adaptiiv, an innovative medical technology company, has received 510(k) clearance from the US Food and Drug Administration (FDA) to market 3D Bolus Software, an advanced software solution that enables the creation of customized personal medical devices using 3D printing, used primarily in the treatment of cancer.

Adaptiiv’s software provides practitioners with a turn-key solution that enables 3D printing of patient-specific uniform thickness bolus, modulated bolus for MERT (modulated electron radiation therapy), High Dose Rate (HDR) surface brachytherapy and other potential ancillary devices. Adaptiiv software fully integrates with existing treatment planning systems and compliments the existing radiation treatment workflows.

Adaptiiv Medical Technologies Inc. (formerly 3D Bolus Inc.) is the definitive 3D technology platform for radiation oncology. Headquartered in Halifax, Nova Scotia, Canada Adaptiiv is shaping the future of patient-specific healthcare through innovation and collaboration with leading Cancer centres throughout the world. Adaptiiv is ISO 13485 certified and has received a CE Mark. Our technology is based on the work of Dr. James Robar, chief of medical physics at the Nova Scotia Health Authority, in partnership with Dalhousie University in Halifax, Canada.