Postby mphelpsmd » 2015-Jan-06 17:12
It's been nearly a year and a half now since I attended a presentation at the ASA on the SEDASYS. At the end of the presentation, I asked the question of whether the FDA approval of this device might grease the wheels at the FDA for target infusors. While SEDASYS is not specifically a target infusor, it does utilize pharmacokinetic calculations (among other things, including a variety of feedback mechanisms). Steve Shafer walked up to one of the microphones and said that he was going to do everything possible to get TCI devices approved by the FDA.
Does anyone have any insights into when the USA might cease to the the last country on the planet to not allow TCI?
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Michael Phelps, MD
Clinical Instructor
Johns Hopkins School of Medicine[/size]