The clearance covers viewing and making medical diagnoses using iPads and iPhones for CT, MR, and nuclear medicine images (including PET), but the software is not intended to replace full workstations, and it's indicated for use only when there is no access to a workstation, according to the FDA.
While smartphones and tablets such as Apple's iPhone and iPad have drawn interest for their potential in radiology applications, broader clinical use has been held back due to an early 2010 FDA decision to classify Mobile MIM as a class III device requiring premarket approval (PMA) instead of a class II device requiring 510(k) clearance.
The situation changed in the summer of 2010, however, when MIM Software was discussing its appeal of the 510(k) decision with the FDA, said Mark Cain, chief technology officer of the Cleveland-based company.
"We were able to identify many of the key issues that concerned them [and] it was jointly decided that another 510(k) would be the best way to proceed," Cain said.
With the clearance of Mobile MIM, the regulatory picture has now brightened, likely ushering in increased investment in these applications.
In its evaluation of Mobile MIM, the FDA said it reviewed performance test results on various portable devices, measuring luminance, image quality (resolution), and noise in accordance with international standards and guidelines. The FDA also reviewed results from demonstration studies with qualified radiologists under different lighting conditions.
"All participants agreed that the device was sufficient for diagnostic image interpretation under the recommended lighting conditions," the FDA said in a statement.
With Mobile MIM, images are compressed for secure network transfer and sent to the appropriate portable wireless device. Mobile MIM also enables physicians to measure distances and image intensity values, as well as display measurement lines, annotations, and regions of interest, the FDA said.
The FDA noted that there can be significant variations in the display performance of mobile devices, even between mobile devices of the same model. However, the Mobile MIM application includes sufficient labeling and safety features to mitigate the risk of poor image display due to improper screen luminance or lighting conditions, according to the FDA.
"The device includes an interactive contrast test in which a small part of the screen is a slightly different shade than the rest of the screen," the FDA said in a statement. "If the physician can identify and tap this portion of the screen, then the lighting conditions are not interfering with the physician's ability to discern subtle differences in contrast. In addition, a safety guide is included within the application."
MIM Software welcomes the clearance, particularly because the FDA had turned down the company's original 510(k) application
"After three years, it is a relief to see this chapter close," Cain said. "We're looking forward to the next step."
By Erik L. Ridley
AuntMinnie.com staff writer
February 4, 2011
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