Cardiac Science, maker of automatic external defibrillators, received an FDA warning and notification for several safety procedure violations at a Wisconsin plant that the agency said had not been adequately resolved. The agency also said it will not approve any forthcoming applications for related devices until the company corrects the safety deficiencies. The company's CEO said the firm is working to address the FDA's concerns, and he expects no financial impacts this year as a result of the warning.

Full Story:

Related Summaries