FDA Grants 510(k) Clearance for 3D LifePrints’ EmbedMed
Liverpool, UK-based 3D LifePrints has received 510(k) clearance from the FDA for its EmbedMed digital client portal.
The platform allows clinicians to order new medical devices such as virtual or physical patient-specific anatomical models. It also includes visualization capabilities that allow for assessments of patient cases.
EmbedMed can also be used as a pre-operative software tool to simulate surgery and evaluate surgical planning, the company said.
The company’s U.S. base is at the Texas Medical Centre in Houston but it plans to open further facilities nationwide starting with New York and Orange County, Calif.