The FDA has given the OK to digital health startup Nephosity to market its image viewing mobile app for diagnostic purposes.
Nephosity said it receive 510(k) clearance for use of its app in situations where a clinician doesn’t have access to the traditional means of viewing CT scans, MRIs and X-rays.
A radiologist, for example, who’s on call but steps outside the hospital to get dinner could still make a diagnosis from an image using MobileCT Viewer, said co-founder and CEO Michael Pan, a former product engineer at DreamWorks. Nephosity’s app communicates directly with a hospital’s picture archiving and communication system (PACS) to retrieve images, and it allows the physician to pan and zoom while looking at the images.
Pan said the Nephosity team is now working on tying up any the loose ends on product development before making the diagnostic version of the app available. “We’ve found that if doctors try something and they find one little piece of it they don’t like, they won’t want to use it again,” he said.
Meanwhile, Nephosity’s cloud-based platform, Jack Imaging, is in private beta. This platform allows medical images to be uploaded and stored in the cloud, so that they be shared any time.
If that platform were to be cleared by the FDA and integrated with MobileCT Viewer, doctors could collaborate on a remote diagnosis. That would be a compelling differentiator when looking at other apps that have been cleared for diagnostic viewing, like Calgary Scientific’s ResolutionMD and MIM Software’s Mobile MIM.
The San Francisco-based startup was part of Rock Health’s second class last year.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
[Image from Nephosity]
