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Regulatory Roundup: Device Ban Supported; Obesity Device Panel; Eyelid Weights

FDA neuro panel supports FDA’s proposed ban of electrical stimulation devices used for “aversive conditioning.” The agency has officially scheduled an advisory panel meeting to consider EnteroMedics’s PMA for the implantable Maestro Rechargeable System as a weight-loss tool in obese patients. More regulatory news.

The FDA Neurological Devices Panel supported the agency’s proposed ban of electrical stimulation devices used for “aversive conditioning” in patients with self-injurious or aggressive behavior during an April 24 meeting. If FDA moves ahead with the recommendation, it would be the second device ever banned by CDRH. The only product category currently banned is prosthetic hair fibers

, which were banned in 1983.

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