Indeed, it seems that way. If it means that the files can be saved to and read on generic equipment rather than expensive specialised equipment, this announcement is big news. For instance, if a consultant can download necessary files on to an Apple laptop whilst they attend a conference in Mauritius, they can consult and sip a martini at the same time and comply with the law. Are they going to schlepp there with a piece of equipment that has no other uses? No.
Ann: PME receives FDA clearance for Visage Ease Pro, page-4
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