New software for facial surgery developed at Houston hospital gets FDA approval
A new technology is helping Houston surgeons with a complicated surgery process — and the software recently got clearance from the U.S. Food and Drug Administration.
The AnatomicAligner, a software program designed to improve planning for craniomaxillofacial surgeries, was developed at Houston Methodist and was funded in part by Houston Methodist's Translational Research Initiative, which is a fund that's dedicating $30 million to product development of promising medical technologies.
The hospital received FDA clearance to market the software, making Houston Methodist a member of an elite group of academic medical centers with an approved medical technology ready for market access, according to a news release.
The technology was developed by Dr. James Xia, professor of oral and maxillofacial surgery, and Dr. Jaime Gateno, chair of the Department of Oral & Maxillofacial Surgery and professor of oral and maxillofacial surgery.
The AnatomicAligner uses computer graphics and modeling technologies to simulate the entire surgery artificially with a goal of allowing surgeons to practice and plan their technique. In addition to TRI funding, Xia and Gateno also received nearly $10 million in funding from the National Institute of Craniofacial and Dental Research, per the release, to develop the methodology and the AnatomicAligner software system.
Craniomaxillofacial surgeries correct congenital and acquired deformities of the skull and face — including those acquired from trauma or congenital abnormalities, such as cleft lip and palate.
"Due to the complex nature of the CMF skeleton, it requires extensive presurgical planning," write the researchers in a description of the technology. "Unfortunately, the traditional planning methods, e.g. prediction tracings and simulating surgery on stone models have remained unchanged over the last 50 years."
The researchers have plans to share their findings in order to improve CMF — as well as other orthopedic surgeries — for the world.
"The success of AnatomicAligner will lead to a new class of imaging informatics platform for CMF surgery. This platform can also be transformed to orthopedic surgery and other medical specialties," the description continues. "Once completed, the software will be freely downloaded from internet by research community.