The pre-FDA clearance version of MobileCT
Nephosity, a San Francisco-based startup, has joined the swelling ranks of companies to receive Food and Drug Administration (FDA) 510(k) clearance for a mobile medical imaging app.
The FDA has approved Nephosity's MobileCT Viewer iPad app for remote diagnostic viewing of CT, MRI and X-ray images when a fixed workstation is not readily available, Nephosity announced this week. The clearance is only good on the current, fourth generation of iPad and does not cover mammography.
Nephosity founder and CEO Michael Pan tells MobiHealthNews that the FDA granted clearance of the app only a "secondary" diagnostic resource because no current tablet can match the high-resolution display properties required for primary radiology workstations. Other makers of mobile imaging apps have received similar clearances; MIM Software is marketing its MobileMIM product as a backup to rather than a substitute for fixed imaging stations.
Though Nephosity MobileCT Viewer has the FDA stamp of approval, the cleared version is not yet available in the iTunes App Store because the company is refining some features. "We're trying to release a new version that works well with Jack Imaging," a Web-based viewing platform from Nephosity that is in private beta, Pan says. Users will be able to log in through either service and see the same set of images without having to import files twice, he explains.
In addition, the company has to wait for Apple to review and accept the update before the FDA-cleared app appears in the AppStore. "The Apple turnaround time is so long," Pan says.
With the iPad clearance in hand, Nephosity is moving forward with plans to seek FDA authorization on other devices and to integrate its technology with electronic health records (EHRs).
One of the six "menu" items in Stage 2 of the Meaningful Use incentive program is for providers to make at least 10 percent of medical images viewable directly through the EHR; hospitals and physicians must meet three of the six menu objectives. Pan says his company, which was a member of mobile health accelerator Rock Health's spring 2012 class of startups, is discussing partnerships with several EHR vendors and medical imaging centers.
Nephosity also will be looking for FDA clearance of Jack Imaging, which runs in HTML5, through Web browsers and on some popular Android tablets, but Pan does not have a timetable for that. Pan says the company is waiting for the next release of the iPad Mini, rumored to have the high-resolution Retina display, before Nephosity seeks FDA clearance on the smaller Apple tablet.
Pan is a former DreamWorks Animation image-rendering pro with credits including "Shrek the Third," "Kung Fu Panda" and "How to Train Your Dragon."