News

Several established manufacturers of neuromodulation and neurosensing systems were on hand at the 2015 International CES show in Las Vegas, NV earlier this month. Neurotech firms active in the healthcare space such as NeuroMetrix, Compumedics, Evoke Neuroscience, and Hocoma Inc. used the show to launch consumer versions of their products or to forge alliances with new firms active in the digital health marketplace.

A significant number of new and established neurotechnology firms are entering the consumer products market, as we cover in our report on the 2015 CES International show on page 7 of this issue. Given the rapidly growing market for consumer neurotech, the industry would be well served on when a new product does or does not need FDA approval. Though many questions still remain, The FDA’s Center for…

The recently announced market approval of Stimwave Technology Inc.’s Freedom 4 injectable stimulation system could have a serious impact on the neuromodulation device industry in the years ahead. The announcement created a buzz among attendees at the recent North American Neuromodulation Society meeting. Stimwave, based in Miami Beach, FL, announced FDA 510(k) clearance to market the company’s wireless, injectable spinal cord stimulation device for relief of chronic back and leg pain.

Neuromodulation industry professionals joined with clinicians, researchers, and neural engineers at the 2014 meeting of the North American Neuromodulation Society, held in Las Vegas, NV earlier this month. Attendance exceeded 2000 at the rapidly growing meeting. NANS sponsored a day-long commercialization session called Invention, Investment, and Invigoration prior to the scientific meeting. Ali Rezai from Ohio State University offered his views on future developments in brain neuromodulation.

As 2014 comes to a close, a look back at events in the last year reveals it was one of the most productive and promising in the history of the neurotechnology industry. Positive developments in research findings, product approvals, startup activity, government funding, investment, and even IPO activity were reported in each issue of this publication. Though not all the news was good, the vast majority of what we reported on in these pages renewed the sense of optimism we displayed in our first issue in 2001.

Valencia Technologies, the Valencia, CA developer of hypertension neuromodulation devices, is one of the newest entrants in the neurotechnology industry. But its management and engineering team is anything but new, featuring executives from established neurotech firms such as Medtronic, Boston Scientific, and Advanced Bionics. The company has developed a subcutaneous neuromodulation system for treatment of hypertension.

One of the greatest challenges confronting investigators and entrepreneurs developing new neurotech therapies has been devising a clinical trial protocol that accounts for the placebo effect. In order to fulfill requirements for a randomized control trial, neurotech device makers often devise a form of “sham” stimulation that prevents trial participants from knowing whether they’re in the treatment or control arm of a study.

The potential market for upper-extremity neuroprosthetics continues to look promising and two recent developments in the U.S. and Europe have addressed critical issues amputees have faced with existing devices. These include difficulty in donning, doffing, and controlling a motorized prosthetic and the lack of sensory input needed for performing tasks requiring the dexterity of a natural arm. In Eu…

About 85 neurotechnology industry professionals met in San Francisco earlier this month for the 14th annual Neurotech Leaders Forum, hosted , the publisher of this newsletter. The conference kicked off with an overview of recent events in the neurotechnology industry. He cited the spate of neurotechnology industry IPOs as a positive indicator of growth. Other noteworthy trends of the last year incl…

Neurotech Reports, the publisher of this newsletter, announced the winners of the 2014 Gold Electrode Awards. The awards were presented at the 2014 Neurotech Leaders Forum in San Francisco on October 20. The Gold Electrode Award for Best New Product was presented to NeuroPace Inc. of Mountain View, CA for its RNS stimulation device. The device, which uses closed loop-stimulation to treat epilepsy, was approved year.