Merge Healthcare Inc., purchased by IBM for $1 billion in a deal completed Tuesday, received a warning letter from U.S. regulators about the potential dangers of software that monitors patients during heart procedures and a system that archives medical images.
Merge failed to show that it had adequately reviewed or evaluated complaints of malfunctions in its devices and allowed its Merge Hemo cardiac monitoring system to be widely used on patients when its effectiveness hadn’t been supported, according to the Food and Drug Administration’s letter dated Sept. 30.
Help employers find you! Check out all the jobs and post your resume.
