In Brief: Respironics
This article was originally published in The Gray Sheet
Respironics: FDA investigating the firm's BiPAP ventilator marketing practices as part of an ongoing reinspection of the company. In a May 15 letter to the New York Times, Respironics President Dennis Meteny says the firm "continues to believe" that its BiPAP ventilator "and its uses are covered by the current FDA clearances." The letter responds to a May 14 Times column which alleged that the firm "kept right on selling millions of dollars worth" of the BiPAP, "blithely disregarding" a Dec. 19 warning letter on the device ("The Gray Sheet" Feb. 6, I&W-9). The warning letter charged that Respironics needed 510(k) clearance for the devices "spontaneous/timed mode" and various promotional claims such as the product's ability to compensate for leaks...
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