510(k) clearances

By Dave Muoio November 15, 2018
Every day sees strides across the field of artificial intelligence, and healthcare is just one of the many industries looking to smart automation as a means to reduce burden and improve results. The last year in particular has brought a wealth of new healthcare focused software tools to the forefront, and as such has ignited debate on how these algorithms are being reviewed and regulated by the...
By MHN Staff September 4, 2013
By Bradley Merrill Thompson In response to my prior post on this topic, athenahealth's VP of Government Affairs, Mr. Dan Haley took the time to write some very thoughtful-provoking comments. I appreciate him taking the time to do so. I think it probably helps everyone to have a thorough debate of these issues. So in the spirit of debate, I’d like to offer a few reactions. As I said in my original...
By Brian Dolan May 30, 2013
Following MobiHealthNews' coverage of the rare action that FDA took last week by sending a medical app developer an "It has come to our attention" letter that instructs it to seek 510(k) clearance for its urine analysis app, two readers wrote in to point out that Biosense Technologies, the maker of the app, had indeed already registered it as a Class I medical device with the FDA. The company...