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Axial3D receives FDA clearance for Axial3D INSIGHT platform
The Fly

Axial3D receives FDA clearance for Axial3D INSIGHT platform

Axial3D announced “that it is the first to receive FDA clearance for an automated, AI-driven, cloud-based segmentation platform for orthopedic trauma, orthopedic, maxillofacial, and cardiovascular applications. This achievement is the second FDA clearance Axial3D has received for its segmentation platform, INSIGHT and a significant milestone for the healthcare industry in its embrace of automation and artificial intelligence to personalize patient care. The FDA clearance is expected to provide a major boost towards scaling up production processes particularly by medical device companies. Our FDA clearance for Axial3D INSIGHT is a testament to how far Axial3D has come,” stated Dan Crawford, Founder and CSO of Axial3D. “From our humble beginnings as a startup to now being recognized as a leading medical technology company, this achievement showcases our dedication to pushing the boundaries of innovation in healthcare. We are immensely proud of our team’s commitment in delivering exceptional patient care using advanced automation, artificial intelligence, and machine learning technologies.” Stratasys Ltd. ( SSYS) led an investment round in late 2022 to help advance Axial3D’s technology and to bring a joint solution to market for healthcare providers and medical device manufacturers. “Stratasys is proud to partner with Axial3D in driving innovation and in transforming the healthcare landscape with 3D solutions that help make personalized healthcare at scale possible,” said Stratasys CEO Dr. Yoav Zeif. “We congratulate Axial3D on achieving FDA clearance for their segmentation platform, leveraging the power of automation and AI as a key business driver for their continued success in the medical sector.” ”

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