Visible Patient, a French company that makes 3D models of human organs to assist surgeons, has received FDA 510(k) clearance for its VP Planning Software Suite.
The software suite has had a CE Mark for six months and has been commercially available in Europe for a year. Via the software, surgeons send radiological data like CT and MRI scans to Visible Patient. In-house designers create 3D models based on that data, and surgeons can then use that data to plan the surgery and as a visual aide to communicate with patients.
“[FDA clearance] represents a key step in our development," Erick Cloix, president of Visible Patient, said in a statement. "We are eager to offer American surgeons this technology that many surgeons in Europe have already adopted."
In Europe, the suite also includes an iOS and Android app on which surgeons can display the models and show them to patients. The app has not yet been cleared by the FDA, and therefore won't be coming to the US market, at least at first.
Various companies have used 3D anatomy maps in medical school education and in a patient-facing context. When Apple announced the new iPad Pro, for instance, the company included a demo of Complete Anatomy, from 3D4 Medical, a company that is working on a clinical tool, but currently offers interactive 3D models for educational purposes.
What sets Visible Patient apart is that the model is custom made for the individual patient based on their CT scan or MRI. This makes the software ideal for "complex pathologies or anatomic variations", the company says.