The US Food and Drug Administration (FDA) has granted approval for Axial3D’s artificial intelligence (AI)-driven, cloud-based medical image segmentation platform.

Called Axial3D INSIGHT, the automated platform is intended for orthopaedic, orthopaedic trauma, cardiovascular and maxillofacial applications.

Receiving its second FDA clearance, Axial3D’s segmentation platform is expected to help medical device companies scale up production processes.

INSIGHT is differentiated by its AWS cloud-based infrastructure, AI algorithms and latest machine learning methods and automates the conversion process of 2D DICOM images such as MRI and CT scans.

These images are converted into 3D print-ready files, 3D visualisations, 3D mesh files or 3D-printed anatomical models, made using Stratasys print technology.

With the ability to process more patient data using the same resources, the platform enables medical device companies to rapidly implement their patient-specific programmes.

Later, the data can be utilised for designing personalised devices and surgical kits such as surgical guides, surgical plans and models.

These products can be 3D printed on Stratasys systems from Digital Anatomy 3D printers to production-scale additive manufacturing systems.

Axial3D founder and CSO Dan Crawford said: “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 to delivering exceptional patient care using advanced automation, artificial intelligence and machine learning technologies.”