Teleradiology App Gets CE Mark

Aycan Medical Systems announced recently that the company has received European clearance to market its mobile imaging app - optimized for use on the iPad 2 - and is awaiting FDA clearance.

The teleradiology app, developed for referring physicians and on-call radiologists, received the CE mark. The app was designed to connect with the company’s OsiriX PRO imaging workstation. The company, based in Rochester, N.Y., recently completed testing for its use on an iPad 2, but the app is also available for the original iPad.

“The application really gets to its capacity using the iPad 2,” said Frank Burkhardt, director for North and Latin American operations for Aycan.

The app securely transmits images from the Osirix system to the mobile device, and doesn’t require a VPN, as images are automatically encrypted, according to the company. The iPad 2 allows users to view the images on a medical monitor.

Burkhardt said the company has recently filed for FDA approval.

In February, the FDA cleared the first mobile app for diagnostic radiology, developed by Cleveland-based MIM Software Inc. The app was approved for view images and making diagnoses based on CT, MRI, and nuclear medical technology. That approval seems to have signaled a shift at the FDA to a greater focus on mobile health applications.