Quick-Med Technologies, Inc. (QMDT.OB) Receives FDA Guidance for NIMBUS Product
Today, Quick-Med Technologies, Inc. announced that the FDA has issued guidance to support the company’s NIMBUS® barrier gauze wound dressings as Class II medical devices. The innovative wound dressing received its initial market clearance in February 2009 following the FDA’s “De Novo” review process, a special clearance program for medical devices that are “not substantially equivalent” to any predicate device. Ladd Greeno, Quick-Med CEO, stated, “This guidance is important because it now lets us pursue other planned medical device applications using our own bandage product as a predicate device. And since we have significant patent protection using this molecule, we…