In January, the FDA's Center for Devices and Radiological Health (CDRH) informed software developer MIMvista that its Mobile MIM image viewing and multimodality fusion software for the iPhone was not substantially equivalent to predicate devices, based on its new proposed indication for displaying medical images for diagnostic use on a mobile/portable device.
Furthermore, the FDA said the device also has new technological characteristics that raise new types of safety and effectiveness questions. As a result, Mobile MIM will need to undergo the more rigorous and time-consuming premarket approval (PMA) process in hopes of garnering marketing clearance.
With expensive and lengthy clinical trials required to demonstrate safety and effectiveness for PMAs, some believe the decision may impact the growing trend toward increased use of mobile devices in medical imaging.
A difficult quest
Cleveland-based MIMvista's odyssey to get FDA clearance for Mobile MIM began with the filing of a 510(k) application in August 2008. Shortly thereafter, the FDA contacted MIMvista and asked it to pull the application from the iTunes App Store; the agency had determined that Mobile MIM's inclusion on the site represented marketing for software that had not yet been cleared, according to MIMvista Chief Technology Officer Mark Cain.
MIMvista complied with the request, and in an attempt to address questions raised by the FDA, filed a new 510(k) application for the software in June 2009. After being in the 510(k) system for more than 200 days without an answer, the company received a "not substantially equivalent" (NSE) letter from the CDRH in January.
Although the company understands the position the FDA eventually took, MIMvista wished the process would have gone a little faster, Cain said.
"This type of open-ended uncertainty is hard for a business to bear," Cain told AuntMinnie.com. "We can only hope the process will get better."
MIMvista will proceed with the PMA process and is communicating with the FDA regarding its plans for clinical trials, which are expected to begin this year.
"We firmly believe in the value of this technology," Cain said. "We know that portable diagnostic imaging tools could provide tremendous benefit to patient care, if they can be demonstrated to be safe and effective."
Meanwhile, Mobile MIM has received the European CE Mark and is currently available in the U.K., Australia, Hong Kong, Singapore, and India.
Per FDA policy, Dr. Alberto Gutierrez , the CDRH director of in vitro diagnostics device evaluation and safety, declined to comment on any specific company or product decision. He did say, however, that the agency has not released a specific policy regarding the use of handheld devices for viewing medical images.
"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," he said.
Other handheld software
Less clear is how the FDA action will ultimately affect software currently available for mobile image viewing. None of the companies reached by AuntMinnie.com said they had been contacted by the FDA regarding their iPhone software. Vendors have typically elected not to pursue a specific 510(k) application for this type of software, considering it to be an extension or subset of FDA-cleared software and labeled for nondiagnostic use.
In evaluating whether a device falls under their purview, the agency determines if it is used as a means to make medical decisions and what claims are being made for it, Gutierrez said.
A number of handheld viewing applications already exist on the market, including the popular OsiriX DICOM open-source image viewer. While the Macintosh version of OsiriX has received FDA clearance through a few third-party companies, the iPhone application has not.
CoActiv Medical Business Solutions of Ridgefield, CT, includes support for OsiriX Mobile as part of its Exam-PACS for iPhone offering.
"When we launched our Exam-PACS for iPhone, we made it very clear that it was not intended for diagnostic purposes, only for review," said CoActiv President and CEO Ed Heere. "We did not pursue a 510(k) since it's not intended for diagnostic [applications]."
Heere noted that despite the excitement involving the iPhone, Apple's upcoming iPad launch may wind up having more of an impact in terms of mobile image viewing.
"The iPhone, because of its size and resolution, will never lend itself to diagnostic interpretation to radiology and cardiology as we understand it today," Heere said. "However, the iPad could very easily provide the resolution required for proper diagnostic interpretation on many types of exams, especially CT, MRI, and ultrasound."
If the FDA's action extends to software used as an image communication tool, it could hinder innovation in this area, said Daniel Valentino, Ph.D., chief technology officer of iCRco of Torrance, CA. iCRco introduced its iClarity medical image viewing application last month for the iPhone.
"I would hope the FDA's goal is to ensure safety while encouraging innovation and competition, and, therefore, one of the goals is to determine the appropriate regulatory process," Valentino said. "For this kind of software, I think the 510(k) is the appropriate way."
Merge Healthcare of Milwaukee elected to focus on providing radiologists with workflow information in its recently debuted eFilm Mobile application for the iPhone, according to general manager Tim Kulbago.
"The application includes a viewer, but we intentionally left out features like measurement tools to keep the viewing portion basic," he said. "In contrast, other mobile app viewers contain multiple measurement tools. Even though other providers' apps say 'not for diagnostic use,' the functions of these other applications tend to give an indication otherwise."
Kulbago believes that an even bigger regulatory matter, however, is the availability and distribution of open-source diagnostic workstation software that has not gone through the FDA registration process.
"These clinicians may or may not be aware that they are practicing medicine with a non-FDA-registered application," Kulbago told AuntMinnie.com. "We believe this presents a larger issue with greater potential impact on quality of care than the question of mobile applications today, and it also sets precedent for potential continued misuse of devices for diagnostic imaging."
Nonetheless, the FDA's decision appears to hold handheld devices such as the iPhone to an unfairly high standard, according to PACS consultant Michael Cannavo of Image Management Consultants in Winter Springs, FL.
"The iPhone actually has much better display resolution that some of the early PACS and teleradiology systems in the early '80s and has infinitely more processing power as well," Cannavo said. "If the FDA is going to take this stance with Mobile MIM, it then needs to regulate all medical imaging software and mandate minimum requirements for combined hardware and software packages. All existing PACS should then be required to go through the PMA process, rather than piggybacking on someone else's 510(k) as substantially equivalent -- as most have already."
By Erik L. Ridley
AuntMinnie.com staff writer
March 23, 2010
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