Medtronic (Minneapolis) stepped into the field of deep brain stimulation (DBS) back in 1987 when it implanted its first DBS system in a patient in France, followed by FDA approval of that system 10 years later to treat essential tremor and tremor associated with Parkinson's disease. This week the company made another giant leap forward in the DBS space with the first implant of a new DBS plus sensing system that, for the first time, enables the sensing and recording of select brain activity while simultaneously providing targeted DBS therapy.
If you like controversy, a job at FDA would be right up your alley, but it’s tempting to think some of these controversies are contrived. The question of the influence of user fees on FDA reviews has surfaced (yet again), but even those who would like to do away with the user fees might find this latest rehashing a bit over the top. An article titled “Risky Drugs: Why the FDA Cannot Be Trusted” at the website for Harvard University is the latest to take...