Medical AMPersonalized Medicine

3D LifePrints’ EmbedMed platform achieves FDA 510(k) clearance

The company's personalized surgery platform includes cranio-maxillofacial products and services

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3D LifePrints, a leading provider of personalized surgery that has supplied thousands of patient-specific devices in the UK and Europe, and more recently in the US, has received FDA 510(k) clearance for the company’s cranio-maxillofacial products and services, which are included in the EmbedMed platform. This clearance follows the company’s ISO 13485 medical certification in 2021.

3D LifePrints’ EmbedMed Platform is an end-to-end solution for surgeons that digitizes the surgical planning process and enables the rapid design and manufacture of patient-specific medical devices. Its functions include the processing of patient input data from image scan data and can be used 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' personalized surgery platform, EmbedMed (Cranio-Maxillofacial products and services), achieves FDA 510(k) clearance.

3D LifePrints’ Point of Care service includes; biomedical engineers, a range of advanced 3D printing hardware, and a suite of software. The embedded nature enables the host institution to enjoy all the benefits of having an ‘in-house’ service including ease of access to an engineer and immediate delivery of devices.

3D LifePrints has launched in the US, with its base of operations at the Texas Medical Centre in Houston. After Houston, 3D LifePrints plans to open more facilities across the US, starting with New York and Orange County, California.

“It is our aim for surgeons across the US to have direct access to personalized 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 personalized devices for a complex case – our highly qualified bio-medical engineers are here to help,” said Henry Pinchbeck, Co-Founder and Chief Executive Officer of 3D LifePrints.

“This clearance is the first step in executing 3D LifePrints’ strategy to bring personalized 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 blueprint for a nationwide rollout,” said Scott Parazynski, US Strategy Director of 3D LifePrints, and former NASA astronaut.

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