Cur is crowdfunding a medical device that isn’t cleared by the FDA, and that’s a problem

A company called Cur is developing a promising new pain-relieving product, according to Mashable, Fast Company, and PC World. Problem is, the company is doing it by launching a $50,000 crowdfunding campaign on its own website prior to filing for the necessary FDA clearance. The move could doom the product before it ever hits the market — or it could point to a glaring loophole in FDA regulations. Continue reading

Women share concerns about permanent birth control device with FDA

WJLA-TV (ABC NEWS), April 2, 2015. NCHR president Dr. Zuckerman accompanied women harmed by Essure permanent birth control to meet with FDA officials. They told FDA that women in terrible pain from Essure got no help from their doctors and then were dumped from the company’s clinical trials. This made the study results look better so that Essure would be approved. Continue reading