Nephosity’s MobileCT Viewer Receives FDA 510(k) Clearance for Diagnostic Image Viewing on iPads
Nephosity, a digital health startup that was a member of Rock Health’s second class, has received clearance from the United States Food and Drug Administration (FDA) for their MobileCT Viewer, a software application for diagnostic image viewing on the iPad.
Nephosity, Inc. builds the platform for anywhere, anytime medical image viewing, sharing, and collaboration, improving the medical imaging workflow for physicians and other healthcare providers, which lowers costs, engages patients, and improves care. This FDA 510(k) clearance reaffirms the quality and safety of MobileCT Viewer, and allows for diagnostic viewing of CT, MRI, and X-ray medical images by trained professionals on the iPad in situations where there is no access to a workstation.
MobileCT Viewer’s many features include:
- Anywhere, anytime access to CT, MRI, and X-ray images
- Image manipulation such as window and level, pan and zoom
- Full resolution images, ensuring that no detail is lost
- HIPAA compliance, with SSL encryption for all information in-transit and 256 bit AES encryption for all patient information at rest
- Measurement of distances, display measurements and annotations
- Verify Lighting Check, which guides the user to determine whether the environmental lighting conditions can accommodate a diagnosis
Nephosity will incorporate the FDA cleared MobileCT Viewer into its medical image platform so that physicians can view images collaboratively and diagnostically. Additionally, Nephosity will expand the platforms and devices on which MobileCT Viewer will run and submit supplementary applications for clearance of clinical diagnostic imaging on devices not already cleared by the FDA.
Nephosity, Inc. builds the platform for anywhere, anytime medical image viewing, sharing, and collaboration, improving the medical imaging workflow for physicians and other healthcare providers, which lowers costs, engages patients, and improves care. In addition to the FDA cleared iPad version, Nephosity offers a non-diagnostic version of its collaborative medical image viewer technology for Windows, Mac OS X, and Android platforms.
For more information, visit www.nephosity.com.