News

The Dawning of Neurogenesis Neural implantation offers a dramatic new tool for researchers and clinicians to restore normal brain function to individuals suffering from a variety of neurological diseases and disorders, as we detail in our article on page 1 of this issue. The field of controlled neurogenesis— directing the growth of new neurons in the brain from within—offers a potential route to ne…

Industry Veterans and Newcomers Come Together at 2011 Neurotech Leaders Forum Staff report About 60 neurotechnology industry executives, investors, and entrepreneurs gathered in San Francisco earlier this month for the 11th annual Neurotech Leaders Forum, produced , the publisher of this newsletter. Keynote speaker Kip Ludwig, newly appointed director of neural engineering at the National Institute…

Modulating the FDA As it was at previous events, the tardiness with which the FDA approves new devices was a major topic at this year’s Neurotech Leaders Forum [see Conference Report, p7]. One potential pathway around this problem that came up this year is marketing neurotech devices to consumer and alternative markets so that FDA approval is not necessary. For example, Magneceutical Health, which…

Noninvasive VNS Device Emerges from Europe , senior technical editor Vagus nerve stimulation for the treatment of medically refractory epilepsy—about one third of cases—was pioneered by Cyberonics, Inc., and over 60,000 patients have received implants worldwide. Now, Cerbomed, a private medical device company in Erlangen, Germany, is pursuing a noninvasive approach to treating epilepsy. The company…

Market Ripe for Nonmedical Neurotech Applications Numerous neuroprosthetic devices are currently being developed U.S., Europe, and Asia. Most of these startups are pursuing a well-established strategy of building a device to treat a specific neurological disorder. Getting a device to market through this strategy involves a lengthy process toward FDA approval and hospital/doctor-mediated reimbursement by Medicare.

Kip Ludwig to Keynote 2011 Neurotech Leaders Forum in San Francisco Kip Ludwig, who was recently appointed as program director in repair and plasticity at the NIH National Institute for Neurological Disorders and Stroke, will deliver the keynote address at the 11th annual Neurotech Leaders Forum, which will take place in San Francisco on October 17-18, 2011. Ludwig will offer attendees his views on his new role with the NIH and how it impacts the neurotechnology industry.

Our Fragile Brains Traumatic brain injury represents one of the most significant application areas for neurotechnology. As we report in our conference report in this issue, there are about 300,000 cases of concussion caused in the U.S.—with about 47,000 of them classified as serious injuries. On top of that, approximately 1,300 children suffer severe or fatal head trauma in the U.S. each year as a result of shaken baby syndrome.

When Neurotech Isn’t Right Neurotechnology devices have proven to be a viable choice in treating and diagnosing a large number of neurological diseases and disorders. But not every neurotech device is right for every patient in every situation and it’s worthwhile for vendors to have a good understanding of when their products are not the best choice. Two recent studies point out some of the issues facing neurotech vendors when alternative treatment options coexist with neurotech solutions.

Regulating Our Complaining Although it’s too early to assess the impact of an Institute of Medicine report on possible changes to the FDA’s process of reviewing medical devices, it’s not too early to gauge public sentiment to efforts to resist additional regulation. Device manufacturers have been concerned about that forthcoming report since Jeffrey Shuren, director of the Center for Devices and Ra…

Neurotech Startups Participate at International Neuromodulation Society Meeting More than 1000 clinicians, neural engineers, and related professionals attended the 2011 meeting of the International Neuromodulation Society, held in London, England last month. The conference began with a full-day session called Future Innovations in Neuromodulation: Bringing New Ideas to Market. The session, oriented…