510K

By Brian Dolan September 23, 2013
PillPhone: One of the first patient-facing mobile apps to get FDA clearance. Last week when departing ONC chief Dr. Farzad Mostashari told MobiHealthNews that he thought the FDA should release its final guidance document for mobile medical apps without delay, he might have known something we didn't. After more than two years since the FDA first published its draft guidance on how it regulates...
By Neil Versel September 19, 2013
Departing national health IT coordinator Dr. Farzad Mostashari would prefer that the Food and Drug Administration unilaterally issue a long-anticipated final guidance on mobile medical apps rather than waiting for inter-agency consensus with the Federal Communications Commission and Mostashari's own Office of the National Coordinator for Health Information Technology. "I testified before Congress...
By Neil Versel August 13, 2013
FDA Senior Policy Advisor Bakul Patel A decision by the Food and Drug Administration to recognize a set of voluntary, industry-developed interoperability standards should make it easier for technology developers to gain 510(k) clearance for new medical devices – including smartphone accessories – that follow such standards. In its annual update to its list of accepted consensus standards for...
By Neil Versel July 31, 2013
Aging in place and disease management technology developer Ambio Health has gained FDA 510(k) regulatory clearance for its flagship Ambio Remote Health Monitoring System. The system, first introduced at the Consumer Electronics Show in January, essentially adds wireless capability to standard home health monitors and automates data collection. Stamford, Connecticut-based Ambio is now free to sell...
By MHN Staff March 26, 2013
By Bradley Merrill Thompson, Member of the Firm at Epstein Becker & Green My wife complains I live in the future, and I suppose that’s true. But on the heels of three days of hearings last week by two subcommittees of the House Energy and Commerce Committee, all focused on mHealth, I feel the urge to plan for the regulatory world after FDA publishes its final guidance. FDA testified the...
By Brian Dolan March 21, 2013
As expected, the third and final (for now, at least) congressional hearing focused on the FDA's regulation of mobile medical apps was the only one that provided new information for those already well-versed in mobile health. While the past two days of testimonies likely helped members of Congress better understand the concerns of those working or lobbying for the healthcare and technology...
By Brian Dolan March 6, 2013
Source: mHealth Regulatory Coalition FDA Report Last week six members of the US House of Representatives Committee on Energy and Commerce wrote a letter to FDA Commissioner Margaret Hamburg MD to ask her when the agency expects to publish its final guidelines for how and when it regulates mobile medical apps as medical devices. The FDA draft guidance document on mobile medical apps was published...
By Brian Dolan December 3, 2012
The FDA has granted a 510(K) Class II clearance to San Francisco-based AliveCor's iPhone-enabled heart monitor, which has been commonly known as the "iPhoneECG" since it first made an appearance at CES two years ago. The company announced the clearance as the mHealth Summit kicks off this week in the Washington DC area. AliveCor will begin pre-selling the $199 clinical-quality, ECG monitor,...
By Brian Dolan April 4, 2011
The FDA cleared Abbott's i-STAT 1 Wireless point-of-care blood analyzer last week, marking the fourth wireless-enabled medical device to receive FDA clearance so far this year. Ascom, Monica Healthcare and Mobisante have each received a 510(k) clearance this year for a connected medical device. The FDA has cleared more than a dozen software apps for mobile devices over the years including one...
By Brian Dolan April 19, 2010
By Bradley Merrill Thompson (I would like to thank Tim Gee of Medical Connectivity Consulting and Mike Robkin for their comments on a draft. The views expressed, right or wrong, are only the author’s and should not be attributed to anyone else.) At mHealth meetings, I keep hearing representatives from hospitals and other healthcare caregivers say they don’t believe FDA regulations extend to...