MediSpectra approval hitches highlight need for US regulatory review
This article was originally published in Clinica
MediSpectra's struggle to gain FDA approval for a product that uses spectroscopy to detect cervical cancer is being cited by AdvaMed, the largest US medical technology industry association, as an example of why Congress needs to change federal device laws. "As a result of inefficiencies in the FDA review process, it has taken the company-a year just to secure an agreement with the agency on clinical trials for the device," the association reported in its most recent Medical Technology & Innovation newsletter, which it sends to lawmakers.
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