St. Jude Medical (St. Paul, Minnesota) took another hit for its Riata line of electrophysiology leads via an FDA announcement that all patients with these leads should be evaluated for lead externalization. The news dropped the firm's shares at the New York Stock Exchange, falling to as low as $36.59 from the day-high of $38. Recent reports had already driven down share prices with reports in July stating that a weak earnings environment is in the firm's future.

By Kelly Roman, Vice President of Fisher Wallace Labs On February 10, 2012, the FDA convened an advisory panel hearing on whether to reclassify cranial electrotherapy stimulation (CES) devices. Despite being a low-risk device, CES has lingered in Class 3 (high risk) for more than 30 years as a result of being a grandfathered 510(k) medical device. The regulatory fate of CES, which is currently cleared to treat depression, anxiety and insomnia, will emerge at a time when antidepressants have been proven ineffective in treating soldiers with post-traumatic stress; CES has had great success treating this population. CES manufacturers such...