Axial3D, a Northern Ireland-based medical technology manufacturer, has obtained clearance from the US Food and Drug Administration (FDA) for the Axial3D INSIGHT medical image segmentation platform, which is designed to display patient data in 3D.

The automated, artificial intelligence (AI) driven, cloud-based segmentation platform has been approved for orthopaedic trauma, maxillofacial, orthopaedic, and cardiovascular applications.

It is the second FDA clearance secured for the segmentation platform by Axial3D, which is engaged in medical segmentation and 3D solutions.

Axial3D INSIGHT’s features include an Amazon Web Services (AWS) cloud-based infrastructure, AI algorithms, and advanced machine learning techniques. The combination enables the automatic conversion of 2D DICOM images, such as CT and MRI scans, into highly accurate 3D visualisations, 3D print-ready files, 3D mesh files, or 3D printed anatomical models by using Stratasys’ print technology.

By automating the traditionally laborious and time-consuming process of manual or semi-manual image segmentation, Axial3D helps healthcare providers and medical device companies to handle more applications efficiently. This results in substantial time savings of hours or days per case and reduced capital expenditures, said the company.

Axial3D founder and CSO Dan Crawford said: “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.”

The Axial INSIGHT platform is designed to help medical device companies expedite their patient-specific programs efficiently, utilising the same resources to process more patient data.

The 3D data can be leveraged to create personalised devices and surgical kits, complete with surgical plans, models, and surgical guides. All of these can be 3D printed using a range of printers, including Stratasys systems, from Digital Anatomy 3D printers to production-scale additive manufacturing systems.