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Rx: Doctors to prescribe firearms?
Company claims federal approval for 9-mm handgun as 'medical device'

A hand injury? If so, a New Jersey company claims it has invented a firearm just for you and that it has received federal approval to market the 9-mm handgun as a "medical device," perhaps even with its cost reimbursable to seniors by Medicare.

Matthew Carmel, president of Constitution Arms in Maplewood, N.J., says the Palm Pistol is designed to be fired by people who have disabling conditions that prevent them from holding a normal handgun and pulling the trigger.

"It's something that they need to assist them in daily living," Carmel, who hopes to manufacture the device, told New Scientist. Currently the Palm Pistol is just at the patent stage.

"The justification for this would be no more or less for a walker or wheelchair, or any number of things that are medical devices," he said.

Carmel expects the handgun to become available in 2010. He estimates it will sell for approximately $300. "I've been getting a lot of calls," he said.

According to the website:

    The Palm Pistol is an ergonomically innovative single-shot double-action only defensive firearm chambered in 9mm that may be fired using either hand without regard to orientation of the stock. Suited for home defense, concealed carry or as a backup gun. It is also ideal for seniors, disabled or others who may have limited strength or manual dexterity. Using the thumb instead of the index finger for firing, it significantly reduces muzzle drift, one of the principal causes of inaccurate targeting. Point and shoot couldn't be easier.

Constitution Arms reportedly claimed on a medical technology blog to have received U.S. Food and Drug Administration approval for the handgun as a medical device – specifically, a "daily activity assist device."

Constitution Arms has said the firm is now attempting to obtain a Durable Medical Code for the pistol which would allow doctors to prescribe it and qualified patients to receive reimbursement through Medicare and, possibly, private insurers.

A spokesman for FDA disputed Carmel's claim to New Scientist, saying, "At this time, there have been no formal designations of the Palm Pistol by the FDA as a medical device."

Carmel insists he received a notice of registration earlier this week for a Class I medical device, a category that includes walking aids. But Bill Maisel, an expert with Beth Israel Deaconess Medical Center in Boston, said Carmel's documents from FDA fall short of the full approval he claims.

Even if the gun is recognized as a legitimate medical device, Carmel has little chance of getting Medicare to pay for it, said Kevin Schulman, an expert on medical device regulation at North Carolina's Duke University Medical Center.

"Medicare does not cover everything that FDA approves," said Schulman. "The first question for Medicare is whether this would be potentially beneficial, and the answer seems to be obviously no. It's not implanted in the body, but the obvious result of this thing could be."

Carmel is undeterred. Constitution Arms is currently taking refundable $25 deposits from those wishing to be among the first purchasers. Clear confirmation the device has FDA approval, or better yet, Medicare approval, along with a growing escrow account of early buyers' deposits, should attract investors Carmel seeks to the venture.