A nail fungus laser treatment device manufacturer have problem with F.D.A.

1304701593 71 A nail fungus laser treatment device manufacturer have problem with F.D.A.It is estimated that more than 20 million people in US infected by nail fungus and change their toes/fingers nails become yellow, thick, and ugly. They are hoping for a faster treatment to remove fungus from their nails. Right now there is no nail fungus remedy made by a pharmaceutical company, which carry a small risk of liver damage, are completely effective to get rid of nail fungus with high rate of success. Podiatrist and patients are pinning their hopes on the experimental laser treatments. 

With the latest medical technology Nomir Medical Technologies in Waltham, Massachusetts., is developing a laser which can be use to get rid of nail fungus called Noveon. It is a type of laser already commonly used by doctors for treatments like cataract surgery, dental work and also for hair removal. Noveon for nail fungus laser treatment was tested  by the manufacturer to cure nail fungus just with four times of laser treatment, and from 39 toenails half are successfully no longer had active nail infections. Laser treatments for nail fungus can help people who have nail fungus but do not take any medication because they afraid of the risk of chemical drugs / liquid.

PathoLase, another company which also developing laser treatment device to get rid of nail fungus, already market their laser device for nail fungus treatment. But this company not yet get federal permission to begin marketing their device. according to PathoLase, there are arround 70 podiatrist in 21 states already offer PinPointe (the name of nail fungus laser treatment device) which cost the patient $ 1,000 or even more if not covered by health insurance.

The permission from F.D.a. cleared the device from PathoLase in 2001 for use in dentistry and not for nail fungus treatment. Technically, the F.D.a. does not regulate the practice of medicine, so doctors are indeed able to use approved drugs and devices for unapproved purposes when they deem it appropriate. But Timothy a. Ulatowski, director of compliance at the Center for Devices and Radiological Health at the F.D.a., said companies were legally allowed to market a medical device only for the specific use for which it had been granted clearance. Selling or promoting a device for unapproved indications is illegal, he said. he added that the company might face action from the agency, ranging from a warning letter to fines, injunctions or product seizures.

  1. Nail fungus laser treatment, a promising solution

A nail fungus laser treatment device manufacturer have problem with F.D.A.

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