Company claims federal approval for 9-mm handgun as 'medical device'

World Net Daily - December 13, 2008 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. 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." 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."