Medical-device technology firms should not be putting patients at risk (via the oops--we didn't know--non-disclosure of risks on our devices). See the link to the story from yesterday's NEJM editorial from Curfman, Morrissey, & Drazen; http://content.nejm.org/cgi/content/full/360/15/1550.
Where is the compromise between the free market/business enterprise and FDA regulation? It better not be on on the risks of the public's health. I for one, vote for patient safety.