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HDE Sought for Experimental Spinal Device
It's not every day that you see a mainstream media piece that goes into detail about a particular regulatory process. But today's Boston Globe has a piece that explains in depth the Humanitarian Device Exemption (HDE) process. It is doing so because a Massachusetts company is applying for an HDE for its device that tries to regenerate spinal nerve cells. The Andara Oscillating Field Stimulator System from Cyberkinetics Neurotechnology Systems Inc.
September 18, 2007
1 Min Read
(Foxborough, MA) delivers electrical pulses to the spine to try to make it regenerate nerve cells. The article also talks about how the HDE process worked for another Massachusetts company, Abiomed Inc., whose application for its Abiocor artificial heart was successful.Whether Cyberkinetics can have the same success, we don't know. The piece quotes one researcher who seems to liken the company to a snake-oil peddler. Regardless, anytime the mainstream media can educate the public as to how FDA really works, that's a good thing.
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