News

Neural engineers and clinical researchers at commercial firms and research laboratories continue to look for new ways to treat tinnitus, which remains one of the greatest unmet medical needs of the 21st century. Nearly 10 percent of the population has experienced ringing in the ear and 10 million Americans seek medical treatment each year. There are few viable therapies available. One of the earliest neurotech approaches to treating severe tinnitus was epidural stimulation of auditory cortex.

The recent news about the FDA’s consent decree alleging manufacturing and quality problems with Medtronic’s Synchromed infusion pump casts a shadow on both Medtronic and the FDA Center for Devices and Radiological Health. The consent decree requires the company to suspend manufacturing and distribution of the pain pumps. While some contend that it’s unreasonable for the FDA to hold products created…

Since its inception, deep-brain stimulation has been a powerful tool for treating neurological disorders. But the invasiveness of the implantation procedure limits DBS to patients who can’t be helped repels some who are good candidates. So we were encouraged to see some ideas for reducing the level of invasiveness of DBS proposed recently. One approach put forward involves carbon nanotube fibers. I…

Observers of the neurotechnology industry have been watching the handful of large publicly-traded neurotech device firms for some time to see which startups would get snapped up in the next M&A deal. So far, 2015 looks like the year of the mega-merger. The announcement that Cyberonics Inc. will merge with Sorin [see article, p5], coupled with Medtronic’s recently closed merger with Covidien, points up a new level of competition in the industry.

The market for implanted neurotechnology devices stands to benefit from new advances electrode materials and coatings that promise to extend the capabilities of current devices. Products such as DBS leads, peripheral nerve stimulators, sensing electrodes, and cochlear implants could all take advantage of enhanced capabilities. Two midwestern U.S. firms have recently developed enhanced coating technologies for implanted electrodes.

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.