News

It’s too early to assess what impact, if any the recent report from Public Citizen criticizing FDA oversight of the SCS industry will have on future regulatory policy [see article p1]. But unlike previous attacks coming from news organizations, this report may carry some weight with regulatory agencies or legislative bodies because of the participation of Victor Krauthamer, a former division director at the Center for Devices and Radiological Health.

Two of the most promising and enigmatic companies to enter the neurotechnology industry in recent years have been Neuralink, founded , and Kernel, founded . The tech entrepreneurs each pumped in millions of their own funds and began hiring experienced neuroscientists and engineers. While both have been tight-lipped about their future plans, recently some new details have emerged. With the exception…

Most of the neural implants in use today rely on metal electrodes that either stimulate or record from neural tissue using the flow of electrons at the neural interface. But at least one commercial firm and several research institutions in Europe and North America are looking at implants that exploit the flow of ions, as opposed to electrons. The capacitive current that flows at an ionic interface is much safer and effective than the faradic current produced .

Neuronetics, Inc., the Malvern, PA manufacturer of neuromodulation systems to treat psychiatric disorders, announced that the FDA has granted Breakthrough Device Designation for the company’s NeuroStar Advanced Therapy System for the treatment of bipolar depression. The FDA’s Breakthrough Device Program is intended to help patients and healthcare providers receive more timely access to breakthrough…

Perhaps more than any other medical field, neurotechnology involves a vast array of variables and parameters that can have a profound effect on the viability of a new therapy or diagnostic test. This panorama of parameters such as target location, intensity, pulse width, and contact material creates vast opportunities for neurotech investigators and entrepreneurs to devise new products. But it also…

With an amended format as an online conference due to the COVID-19 pandemic, the 2020 Bioelectronic Medicine Forum was held on April 7 with more than 100 attendees from the industry, research, and investment communities. Projected to grow to $14 billion by 2025, the field is very quickly gaining ground and building investor interest. This event highlights some of the recent developments, investment activity, and emerging companies.

As Neurotech Reports begins our third decade of coverage of the neurotechnology industry, we’d like to look back on 2020 to see what lessons we can apply to the post-pandemic era that awaits us on the other side. Though the year started with many positive research and commercial developments, it’s hard to downplay the impact that COVID-19 has had on our industry. In large part because many states a…

A number of neurotechnology firms and researchers have begun a spirited effort to develop potential treatments for COVID-19. While much of the biomedical research in the U.S. has been oriented toward pharmaceutical and biologics interventions and diagnostics, there are several lines of approach that involve bioelectronic medicine. One neurotech firm taking a leading role in this effort is electroCore, Inc., the Basking Ridge, NJ bioelectronic medicine company.

The coronavirus pandemic that has paralyzed much of the world in the last several weeks has certainly taken a toll on the neurotechnology industry. As was discussed in several sessions at the 2020 Bioelectronic Medicine Forum earlier this month [see conference report, p6], venture capital investment has screeched to a halt, and some early-stage neurotech firms face an uncertain future because of disruptions in clinical trials, research activity, and supply chains.

Cirtec Medical Corp., the Brooklyn Park, MN manufacturer of neuromodulation system components and subassemblies, announced that it has acquired intellectual property and certain assets from Nuvectra Corp., the Greatbatch spinoff that recently filed for bankruptcy protection. Cirtec will leverage this technology to support customers’ development of neuromodulation products, providing an FDA-approved platform with a complete design history file to leverage for a variety of therapeutic applications.