So what is NEW about this approval? It was already outlined in their Filings here: http://www.sec.gov/Archives/edgar/data/1496819/000101489713000030/dmhform8kam1v7.htm Project Development Timeline - Complete • December 2011 – FDA Class 2 Submission for TouchPACS • January 2012 – FDA Class 2 Approved and is/was also available on the FDA page http://www.accessdata.fda.gov/cdrh_docs/pdf11/K112008.pdf approval Date WAS 06.Jan.2013