In January, a moment that all kinds of mobile application developers have long feared finally arrived, when the FDA decided that an iPhone image viewer from Cleveland-based vendor MIMvista was a class III medical device that requires pre-market approval.
"We understand the potential and benefit of having these devices in the marketplace, but we would like to make sure that they perform in a way that would lead to [their] safe and effective use and that the public is protected," Dr. Alberto Gutierrez of the FDA's Center for Devices and Radiological Health, tells radiology news site AuntMinnie. Since MIMvista designed the app, called Mobile MIM, as a diagnostic product, the company is making plans to conduct clinical trials--even though Mobile MIM already carries a European seal of approval and is available in the UK, Australia, Hong Kong, Singapore and India.
The disposition of other image viewers isn't so certain. AuntMinnie contacted other medical imaging app developers, and none said they had heard from the FDA about their iPhone products.
"When we launched our Exam-PACS for iPhone, we made it very clear that it was not intended for diagnostic purposes, only for review," says Ed Heere, CEO of CoActiv Medical Business Solutions. "The iPhone, because of its size and resolution, will never lend itself to diagnostic interpretation to radiology and cardiology as we understand it today," he added.
But with Apple's larger, higher-resolution iPad ready to hit the market next week, all bets are off.
To learn more about possible regulation of mobile image viewers:
- read this AuntMinnie story (reg. req.)