Competitive Technologies has announced that the FDA has issued a 510k letter of authorization allowing US sales of the company's pain therapy medical device.
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According to Competitive Technologies (CTT), the device is a non-invasive method for rapid treatment of high-intensity oncologic and neuropathic pain, including pain resistant to morphine and other drugs.
The FDA authorization expands CTT’s opportunities for sales in both the US and globally. CTT has exclusive worldwide rights to this patented device. The CTT device also has Medical Device CE certification from the EU allowing sales throughout Europe and several other countries, the company said.
Aris Despo, CTT’s executive vice president of business development, said: “Our initial focus in the US will be to the major US cancer centers, and to select medical equipment distributors for sales to hospitals, pain clinics, hospice centers and pain management specialists.
“The FDA approval and our international distributors are significant steps in CTT’s global commercialization of this breakthrough medical device, which offers relief to patients suffering extreme pain. Our device provides a valuable tool to the clinician in offering an effective treatment program that can positively impact the quality of life of a patient who has not otherwise responded to standard therapeutic protocols, including morphine.”
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