News

One of the key themes emerging from the 2019 IEEE Conference on Neural Engineering, held in San Francisco earlier this month, is the often treacherous path of bringing a new neuromodulation therapy from research lab to regulatory approval [see Conference Report, p7]. One of the keynote speakers at the event, Mark George from the Medical University of South Carolina, offered his advice to entrepreneurs seeking to maximize the probability of a successful clinical trial and market approval.

April has been a busy month for the staff of Neurotech Reports. In the weeks following our Second Annual Bioelectronic Medicine Forum held in New York City earlier this month [see Conference Report, p7], we’ve put the finishing touches on our new market research report, The Market for Bioelectronic Medicine: 2020-2025 [see article, p3]. One of the challenges in generating the data for this report h…

The neurotech market for treating psychiatric disorders has expanded considerably in recent years and there are a number of new indications on the horizon. Several new alternatives for implanted, noninvasive, and diagnostic devices have emerged just in the last few months. The effort to develop a DBS therapy for major depression continues despite the trial failures six years ago. In the wake of UCS…

The much-anticipated reorganization of the FDA Center for Device and Radiological Health began implementation this month. The most significant change will be the realignment of offices around the total product lifecycle. The agency will now promote a team approach around key areas of the medical device industry. It is expected to “enhance communication” among the staff within CDRH and streamline “a…

Neural engineering professionals from across the globe attended the 9th International IEEE/EMBS Conference on Neural Engineering, held in San Francisco, CA earlier this month. Several neurotech luminaries delivered keynote addresses and featured lectures during the event. Robert Knight, professor of psychology and neuroscience director emeritus at Helen Wills Neuroscience Institute at UC Berkeley, delivered the opening keynote on March 20.

One of the key themes emerging from the 2019 IEEE Conference on Neural Engineering, held in San Francisco earlier this month, is the often treacherous path of bringing a new neuromodulation therapy from research lab to regulatory approval [see Conference Report, p7]. One of the keynote speakers at the event, Mark George from the Medical University of South Carolina, offered his advice to entrepreneurs seeking to maximize the probability of a successful clinical trial and market approval.

SNS Market 201902 February 2019 issue The market for sacral nerve stimulation systems to treat bowel and bladder disorders has been dominated portfolio. But two new publicly traded U.S. firms are seeking to take SNS market share from Medtronic while several others are exploring other neuromodulation modalities. According to the Market for Neurotechnology: 2018-2022, the worldwide neuromodulation ma…

One of the most confounding challenges facing the neurotechnology industry is the lack of awareness of neurotech therapies among the public and clinician communities. It is not enough to have a neurotech device that offers therapeutic advantages compared to traditional medical management for a target patient population. If the patient community and the clinician base serving that community is not sufficiently aware of the device and what it can offer, then that device is less likely to achieve commercial success.

Vendors of visual prosthetic systems have expanded their product offerings and also their target market in recent months as the emerging industry continues to expand. Both Second Sight and Pixium Vision announced significant commercial and clinical progress at the Digital Medicine and Medtech Showcase in San Francisco, CA earlier this month. Second Sight CEO Will McGuire provided preliminary results from the first five patients in a feasibility study of the company’s Orion cortical stimulation system.

Nearly 3000 pain doctors, neurosurgeons, neural engineers and related professionals attended the 2019 meeting of the North American Neuromodulation Society in Las Vegas, NV earlier this month. Several neuromodulation device vendors used the show to report study results or new product introductions. Keynote speaker Sam Quinones, a journalist and author, related stories of how the pharmaceutical industry used an army of sales reps to push opioids on doctors and patients in the last two decades.