I just read the JAMA article on pacemaker approval processes and posted an article about it at http://tinyurl.com/ya42spk. This is kind of the Cliff's Notes version of the article, if you care to read it. The article itself is pretty dense and hard to get through unless you like reading a lot of scientific data.

Bottom line: the testing methods used by manufacturers to get pacemakers and ICDs cleared by the FDA could be more scientifically sound.