CIVCO Radiotherapy are excited to announce 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market Adaptiiv’s 3D bolus software in the U.S.
CORALVILLE, Iowa, July 27, 2018 /PRNewswire/ -- CIVCO Radiotherapy, the leading global provider of high quality, innovative, patient-centric radiotherapy solutions and Adaptiiv (formerly 3D Bolus), the definitive 3D technology platform for radiation therapy, are excited to announce 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market Adaptiiv’s 3D bolus software in the U.S. Adaptiiv’s 3D bolus software is an advanced software solution that enables the creation of customized personal medical devices using 3D printing in the treatment of cancer.
CIVCO and Adaptiiv are partnering to distribute software applications as a turn-key solution that enables 3D printing of patient-specific simple or modulated thickness bolus and high dose rate (HDR) surface brachytherapy applicators. The software application integrates directly with existing treatment planning systems allowing the planning software to calculate the treatment plan and provides the ability to 3D print a patient-specific radiotherapy bolus or applicator. This innovative technique requires less time and replaces the need for hard-to-fit simple bolus and expensive applicators and provides a more comfortable fit for the patient.
“The Adaptiiv 510 (k) clearance is exciting and significant to fulfilling our mission of improving patient outcomes worldwide. The ability to utilize images from the treatment planning system and provide customized three-dimensional bolus and applicators is yet another way we are involved in improving the quality and efficiency of care as well as the patient experience,” said Nat Geissel, president of CIVCO Radiotherapy.
“The 510(k) clearance uniquely positions Adaptiiv to fuel the growth of personalized medicine through elegantly simple, intuitive technology,” stated Peter Hickey, CEO of Adaptiiv. “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.”
About Adaptiiv
Adaptiiv (formerly 3D Bolus Inc.) is the definitive 3D technology platform for radiation oncology. Headquartered in Halifax, Nova Scotia, Canada our technology platform seamlessly integrates into existing procedures to provide an end-to-end solution which facilitates the design and fabrication of personalized medical devices using 3D printing. Adaptiiv, formerly 3D Bolus, is ISO 13485 certified, has received a CE Mark and is 510(k) cleared.
About CIVCO Radiotherapy
CIVCO Radiotherapy has over 35 years’ experience developing, manufacturing and providing high-quality, innovative, patient-centric solutions in radiotherapy. These solutions include: advanced patient immobilization and positioning hardware and consumables, fiducial markers, couchtops and overlays, software, patient care products and advanced 6DOF robotic patient positioning. Corporate information is available at www.CivcoRT.com.
For further information, please contact:
Shelli Locklear
Sr. Marketing Manager
CIVCO Radiotherapy
Tel: 319-248-6619
Shelli.Locklear@CivcoRT.com
COPYRIGHT © 2018. CIVCO IS A REGISTERED TRADEMARK OF CIVCO MEDICAL SOLUTIONS. ALL OTHER TRADEMARKS ARE PROPERTY OF THEIR RESPECTIVE OWNERS. ALL PRODUCTS MAY NOT BE LICENSED IN ACCORDANCE WITH CANADIAN LAW. 2018C1423 REV. A
View original content:http://www.prnewswire.com/news-releases/civco-partner-adaptiiv-receives-fda-510k-clearance-to-market-3d-bolus-software-300687875.html
SOURCE CIVCO Radiotherapy
