Adaptiiv Receives FDA 510(k) Clearance to Market 3D Bolus Software
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, July 18, 2018
/CNW/ – Adaptiiv, an innovative medical technology company announced today that it received 510(k) clearance from the U.S. 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.
Each module of Adaptiiv’s software is designed to solve challenges faced by today’s therapists, dosimetrists, and oncologists such as air gaps in bolus, sparing healthy tissues in electron treatments and the fabrication of complex brachy devices. The company’s software is already used in Canada, Australia, Israel, Ireland and England.
“This 510(k) clearance uniquely positions Adaptiiv to fuel the growth of personalized medicine through elegantly simple, intuitive technology,” notes Adaptiiv CEO, Peter Hickey. “Our technology platform is the first of its kind and allows users to easily design patient-specific devices that can be 3D printed and used during radiation treatment.”
Coupled with the recent announcement of its global distribution agreement with CIVCO Radiotherapy, the leading global provider of high quality, innovative, patient-centric radiotherapy solutions, Adaptiiv continues to make significant strides in the battle against cancer and transforming novel and experimental ideas into real world applications.
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.