FDA clears iPad app for pre-operative surgical planning

By Aditi Pai
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TraumaCadIsrael-based Voyant Health, a subsidiary of Germany-based medical technology company Brainlab, received FDA clearance for its iPad app, called TraumaCad Mobile, which helps orthopedic surgeons with their pre-operative surgical planning.

“For over a decade, thousands of orthopedic surgeons have been using our TraumaCad technology to plan surgery," Brainlab General Manager of Orthopedics Marc Mackey said in a statement. "In the past several years, mobile devices have transformed how surgeons and healthcare professionals work by enhancing data access and productivity. With the mobile version of TraumaCad, digital templating can now be accessed from any web browser or iPad, enabling surgeons to be more productive while also providing access to data for better inventory management.” 

TraumaCad Mobile imports medical images from hospital imaging systems or secured cloud storage via Brainlab's Quentry image sharing service. It also calibrates the images, enables users to measure lengths and angles of the images, visualize the results of the operation, and save the plans in the cloud. The app also offers a library of templates that surgeons can use to plan surgery. Surgeons can also share their plans with each other using Quentry.

"The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and for positioning the template," the Apple AppStore description explains. "Clinical judgment and experience are required to properly use the software."

Until now, the TraumaCad offering was available on desktop computers. It received its first FDA 510(k) clearance in 2004. The company said the software is installed in more than 2,000 locations.