Re: medical guns!

["Larry Seltzer" <larry () larryseltzer com>]

http://www.google.com/hostednews/ap/article/ALeqM5gX8fvj4MkM30m7rPfghQ_I
NA2qfgD94UQUEG1

FDA nixes proposed 'prescription pistol'

By RICARDO ALONSO-ZALDIVAR - 19 hours ago

WASHINGTON (AP) - It could have been the world's first prescription
pistol. The single-bullet Palm Pistol set the Internet abuzz with
speculation that Medicare might even pay for the elderly and disabled to
pack heat.

But Monday the Food and Drug Administration said the Palm Pistol doesn't
have a shot of being listed as a medical device, and revoked the
registration issued to its inventor only last week.

"The FDA has determined the product is not a medical device," the agency
said in a statement.

The inventor is crying foul. "I would assume it's due to political
pressure," said Matthew M. Carmel, from Maplewood, N.J. He said he's
researching a possible appeal.

Medicare, the giant health care program for seniors and the disabled,
would have never covered guns for grandmas anyway. "Medicare will not
cover it because there is no approved category for weapons," said
spokesman Peter Ashkenaz. "So it would not be viewed as reasonable and
necessary."

Carmel said the elderly and disabled are easy targets for criminals, and
the Palm Pistol could be an equalizer. Shaped like an oval, it fits in
your palm. The barrel sticks out through your fingers. And instead of
pulling a trigger, you push down on a button with your thumb. No working
models exist yet, Carmel added.

But he said he wanted to start advertising to seniors, so he called the
FDA and was advised to register his company, Constitution Arms, as a
medical device facility and list the Palm Pistol as a "recreational
adaptor." The registration seemed to go through without any problems.

FDA spokeswoman Siobhan DeLancey said Carmel apparently got some bad
advice from an FDA representative.

And maybe he should have paid more attention to the fine print on the
registration notice. It said: "Registering ... does not, in any way,
constitute FDA approval of your facility or your devices."


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