Aycan Medical Systems, a maker of picture archiving and communication systems (PACS) and other storage and distribution technology for medical imaging, has received FDA 510(k) clearance for its Aycan Mobile teleradiology app for the iPad.
The FDA has approved Aycan Mobile diagnosis from computerized tomography (CT) and magnetic resonance imaging (MRI) modalities only. The clearance does not cover mammography.
According to Aycan, which has dual headquarters in Rochester, N.Y., and Wuerzburg, Germany, the iPad app should only be used for primary diagnosis when a full workstation is not available. Instead, Aycan Mobile is meant to supplement the company's OsiriX Pro imaging workstation.
"This solution supports the growing demand for remote and portable access to medical images while lowering costs," Frank Burkhardt, director of Aycan's North & Latin American operations, says in a company statement. "Aycan Mobile allows radiologists to work remotely more easily and to better communicate/ collaborate with referring physicians and other medical personnel helping to improve patient access to services, especially in rural areas."
The app is designed for quick, secure transfer of Digital Imaging and Communications in Medicine (DICOM) images from hospitals and imaging center to the iPads of on-call and referring physicians. It also supports bedside image review and teleconsulting with other physicians, the company says.
Aycan Mobile previously received the European CE Mark. It also has been available in the Canadian iTunes store for a month.