Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in POLITICO Morning eHealth, in “Hypertense About Blood Pressure App.”
Following is an excerpt:
A quarter of trial subjects were told their blood pressure was A-OK when in fact, they had hypertension. No big deal – if it weren’t for FDA regulations, which as Epstein, Becker & Green lawyer Bradley Merrill Thompson told our own Arthur Allen, is a problem for the class-II (or medium-seriousness) app.
“Inaccuracies of the type found in this study would be very concerning to FDA as a matter of public health,” Thompson said. (AuraLife’s CEO wouldn’t say whether he’s been in contact with FDA or FTC).