Current regulatory news

US FDA Clearances

Axial3D’s approval of Axial3D INSIGHT – an automated, artificial intelligence-driven (AI), cloud-based segmentation platform is expected to provide a major boost toward scaling up production processes by medical device companies.

With its AWS cloud-based infrastructure, AI algorithms, and advanced machine learning (ML) techniques, Axial3D INSIGHT automates conversion of 2D DICOM images such as CT and MRI scans into accurate 3D visualizations, 3D print-ready files, 3D mesh files, or 3D printed anatomical models, made with Stratasys printers.

The Axial INSIGHT platform allows medical device companies to accelerate their patient-specific programs quickly by processing more patient data with the same resources. This 3D data can then be used to design personalized devices and surgical kits including surgical plans, models, and guides, that can be 3D printed on various printers including Stratasys systems from Digital Anatomy 3D printers to production-scale additive manufacturing systems.

https://axial3d.com;
https://www.stratasys.com

Exactech received 510(k) clearance for its advanced Activit-E polyethylene for the Truliant knee replacement system. Activit-E optimizes the balance of material strength and toughness through chemically crosslinked polyethylene, while eliminating the need for gamma irradiation technology used in previous generations of polyethylene. The material is designed to maintain active oxidative resistance and long-term, high-performance, including strength and stabilization.

This new generation polyethylene is the latest innovation by Orhun Muratoglu, Ph.D., director of the Harris Orthopedic Laboratory at Massachusetts General Hospital in Boston. Muratoglu invented the first crosslinked polyethylene, and the first of multiple generations of vitamin E, antioxidant polyethylene for leading orthopedic companies.

The first products for Activit-E will launch in the beginning of Q3 2023 for select U.S. customers. Global expansion will begin in 2024.

https://www.exac.com