Titan Medical, a medical device company focused on the design, development and commercialisation of a robotic surgical system for application in single-port minimally invasive surgery, has announced it has achieved hardware design freeze for its single-port robotic surgery system.
Hardware design freeze is thought to be an essential milestone in the system design process as it allows Titan to complete various design verification and validation activities such as preclinical studies, in preparation for submitting an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) for human confirmatory studies. Titan has already begun procuring hardware for the production of systems for the IDE studies.
Titan believes that this research shows how the company has a differentiated surgical robot. The organisation is on track to file by year-end 2019 its 510(k) application with the FDA and technical file for the CE mark in Europe.
This design freeze is the result of engineering work based on product feedback gathered from extensive preclinical feasibility studies at three Centres of Excellence; Institut Hospitalo-Universitaire de Strasbourg (IHU Strasbourg), Florida Hospital Nicholson Centre, and Columbia University Medical Centre.