3D LifePrints has announced FDA 510(k) clearance approval for their Cranio-Maxillofacial products and services. This clearance follows on from their ISO 13485 medical certification in 2021.
The EmbedMed Platform is an end-to-end solution for surgeons that digitises the surgical planning process and enables the rapid design and manufacture of patient-specific medical devices. It’s functions includes the processing of patient input data from image scan data and as a pre-operative software tool for simulating and evaluating surgical planning options. The output files from the system can be provided digitally or as physical models and surgical guides for use in surgery.
3D LifePrints has launched in the US with its base of operations at the Texas Medical Centre in Houston. After Houston, 3D LifePrints will be opening further facilities across the US starting with New York and in Orange County, California.
Henry Pinchbeck, Co-Founder and Chief Executive Officer said “It is our aim for surgeons across the US to have direct access to Personalised Surgical planning and patient-specific devices. EmbedMed works at scale; whether you are a hospital looking to set-up a Point of Care 3D facility or a surgeon that wants personalised devices for a complex case."
Scott Parazynski, 3D LifePrints US Strategy Director and former NASA astronaut said: “This clearance is the first step in executing 3D LifePrints’ strategy to bring Personalised Surgery to the US. Our facility at the Texas Medical Center, which enables our engagement with hospitals such as Houston Methodist and MD Anderson, will act as the blue-print for a nationwide roll out.”