A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
Zoll Medical received clearance in the U.S. for the X Series monitor/defibrillator, a portable EMS device that weighs less than 12 pounds. Because of its compact size and weight, the X Series may find use in military and air medical units, as well as in ground ambulances. MedGadget