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Axial3D’s INSIGHT™ Medical Image Segmentation Platform Receives FDA Clearance

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Axial3D Receives FDA Clearance for Axial3D INSIGHT™ Medical Image Segmentation Platform
Medical personnel using the Axial3D software/Source: Axial3D

Axial3D, a leader in medical segmentation and 3D solutions, announced that it is the first company to receive FDA clearance for its Axial3D INSIGHT™ Medical Image Segmentation Platform, an automated, AI-driven, cloud-based segmentation platform for orthopaedic trauma, orthopaedic, maxillofacial, and cardiovascular applications.

This is Axial3D’s second FDA clearance for its segmentation platform, INSIGHT™, and a significant milestone for the healthcare industry in its embrace of automation and artificial intelligence to personalise patient care. The FDA approval is expected to give medical device companies a significant boost in scaling up production processes.

Axial3D INSIGHT™ Medical Image Segmentation Platform

Axial3D Receives FDA Clearance for Axial3D INSIGHT™ Medical Image Segmentation Platform/Source: Axial3D/YouTube

Axial3D 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 using Stratasys print technology, thanks to its AWS cloud-based infrastructure, AI algorithms, and advanced machine learning techniques. Axial3D enables healthcare providers and medical device companies to address more applications while saving hours or days per case and reducing capital expenditures by automating the traditionally arduous and time-consuming task of manual or semi-manual image segmentation.

“Our FDA clearance for Axial3D INSIGHT™ is a testament to how far Axial3D has come. 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.”

– Dan Crawford, Founder and CSO, Axial3D

Axial3D is equipping healthcare professionals with powerful tools to access patient data in 3D and grow their programme by incorporating automation and AI into the workflow. Surgeons can improve diagnostic accuracy, treatment planning, and surgical intervention by having more visible patient data in 3D.

The Axial INSIGHT™ platform also enables medical device companies to quickly accelerate patient-specific programmes by processing more patient data with the same resources. This 3D data can then be used to create personalised devices and surgical kits, such as surgical plans, models, and surgical guides, which can be 3D printed on a variety of printers, including Stratasys systems ranging from Digital Anatomy 3D printers to production-scale additive manufacturing systems.

In late 2022, Stratasys led an investment round to help Axial3D advance its technology and bring a joint solution to market for healthcare providers and medical device manufacturers.

According to Stratasys CEO Dr. Yoaf Zeif, “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.”


About Manufactur3D Magazine: Manufactur3D is an online magazine on 3D Printing. Visit our Tech News page for more updates on Global 3D Printing News. To stay up-to-date about the latest happenings in the 3D printing world, like us on Facebook or follow us on LinkedIn and Twitter.

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Manufactur3D is an Indian Online 3D Printing Media Platform that reports on the latest news, insights and analysis from the Indian and the Global 3D Printing Industry.
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