Axial3D has announced that it has received FDA clearance for an automated, AI-driven, cloud-based segmentation platform for orthopaedic trauma, orthopaedic, maxillofacial, and cardiovascular applications. The company says the achievement is the second FDA clearance it has received for its segmentation platform, INSIGHT.
Axial3D says the FDA clearance is expected to provide a “major boost” towards scaling up production processes particularly by medical device companies. Using AWS cloud-based infrastructure, AI algorithms and advanced machine learning techniques, INSIGHT automates the conversion process of 2D DICOM images such as CT and MRI scans into accurate 3D visualisations, 3D print-ready files, 3D mesh files, or 3D printed anatomical models, made with Stratasys 3D printing technology according to Axial3D.
The company says that by automating the “traditionally arduous and time-consuming” task of manual or semi-manual image segmentation, it enables healthcare providers and medical device companies to address more applications while saving hours or days per case.
“Our FDA clearance for Axial3D INSIGHT is a testament to how far Axial3D has come,” said Dan Crawford, Founder and CSO of Axial3D. “From our humble beginnings as a startup to now being recognised 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.”
The INSIGHT platform also allows medical device companies to accelerate patient-specific programs quickly by being able to process more patient data with the same resources. The 3D data can be used to design personalised devices and surgical kits that include surgical plans, models, and surgical guides that Axial3D says can be 3D printed on a variety of printers.
Stratasys led an investment round in 2022 to help advance Axial3D’s technology and to bring a joint solution to market for healthcare providers and medical device manufacturers.
Stratasys CEO Yoav Zeif said: “Stratasys is proud to partner with Axial3D in driving innovation and in transforming the healthcare landscape with 3D solutions that help make personalised healthcare at scale possible. 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.”