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www.fdanews.com/articles/170568-orthopedic-surgical-planning-ipad-app-gains-fda-clearance

Orthopedic Surgical Planning iPad App Gains FDA Clearance

March 31, 2015

Brainlab subsidiary Voyant Health announced last week that its orthopedic surgical planning iPad app, TraumaCad Mobile, has won FDA clearance. The TraumaCad previously was available only for a workstation or personal computer after gaining 510(k) clearance in 2004.

TraumaCad Mobile works by importing medical images from hospital imaging systems or cloud storage through Brainlab’s Quentry service. Medical personnel can then calibrate images, measure the images’ lengths and angles, fix prostheses, visualize operation results such as fracture reductions or osteotomies, and save the plans.

The app includes a library of surgical templates — among them, an automatically planned replacement hip surgery — and allows image-sharing through Quentry. The software features the ability to be integrated with existing PACS systems using enterprise-grade security or act as a stand-alone device, the Germany-based devicemaker said.

TraumaCad Mobile means surgical digital templating can be accessed from any web browser or iPad, which will allow surgeons to work more efficiently, says Marc Mackey, Brainlab’s general manager of orthopedics.

TraumaCad software is installed in more than 2,000 locations.  — Jason Scott