Valencia Technologies said today it won FDA investigational device exemption approval to launch a pivotal trial of its eCoin neurostimulation device exploring its ability to treat overactive bladder. The system, which is approximately the size of a nickel, is designed to implanted in a 10 minute procedure and send electrical impulses to the tibial nerve to […]
FDA approves Valencia’s eCoin neurostim trial
Valencia Technologies said today it won investigational device exemption approval from the FDA to begin a trial of its eCoin neurostimulator for treating drug-resistant hypertension. The company is slated to pick up 300 patients on at least 3 antihypertensive drugs for a trial of the coin-sized device, which is designed to be placed in the forearm […]
Report: AdvaMed CEO Ubl to leave for top spot at PhHRMA | Personnel Moves
Steve Ubl, the longtime CEO at medical device lobby AdvaMed, is reportedly leaving the organization after 17 years to take the top spot at the pharmaceutical industry’s largest trade group, the Pharmaceutical Research and Manufacturers of America or PhRMA. The Hill, citing an unnamed source, said that Ubl “will more than likely” take over as […]
How Valencia Technologies got its anti-hypertension implant to trial for less than $11m
Jeff Greiner would be the 1st to tell you that developing a neurostimulation implant is an expensive process. It took $100 million for Advanced Bionics to develop a cochlear implant, Greiner told MassDevice.com, and another $50 million for its neurostim device. CVRx has raised more than $250 million for its neurostim implant for treating cardiovascular conditions, he noted. That’s why […]
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