France-based Visible Patient has received FDA 510(k) clearance for its VP Planning Software Suite, which already got the European CE Mark and has been selling on the Old Continent for a year.
Said software allows surgeons to send radiological data like CT and MRI scans to Visible Patient where in-house designers create 3D models based on the data received. Surgeons can then use these models to plan the surgery as well as a visual aide to communicate with patients.
“[FDA clearance] represents a key step in our development,” said Erick Cloix, president of Visible Patient. “We are eager to offer American surgeons this technology that many surgeons in Europe have already adopted.”
VP Planning Software Suite includes iOS and Android apps using which surgeons can display the models and show them to patients.The suite includes iOS and Android apps using which surgeons can display the models and show them to patients. That app has not yet been cleared by the FDA, though.
What makes Visible Patient different from other 3D body modeling companies is the fact that it creates custom models based on the data surgeons provide. This, the company claims, make their software ideal for “complex pathologies or anatomic variations.”
[Via: mobihealthnews]