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Mainstay Medical, the Dublin, Ireland manufacturer of neuromodulation systems, announced FDA approval of ReActiv8, its implantable restorative neurostimulation system for chronic low back pain. The FDA approval grants Mainstay the right to market ReActiv8 in the U.S. as an aid in the management of intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced in adults who have failed therapy, including pain medications and physical therapy, and are not candidates for spine surgery.

As with so many conferences held in 2020, the MDIC Annual Public Forum has transformed itself from a multi-day in-person event to a series of virtual meetings. The Medical Device Innovation Consortium is a public-private partnership that focuses on advancing medical device regulatory science for the benefit of the end-user or patient. This consortium is unique to the medical device landscape since…

Neurotech Reports announced it will offer a commercialization workshop for neurotech startups and established firms seeking to launch new products on July 8. The workshop, hosted on Zoom, will feature short courses from NBR editors James Cavuoto, Jennifer French, Jeremy Koff, and Jo Jo Platt. The free morning sessions will feature short courses devoted to preparing a pitch deck, developing a financial model, attracting early-stage investment, and assessing the market opportunity.

Neurotech Reports announced it will offer a commercialization workshop for neurotech startups and established firms seeking to launch new products on July 8. The workshop, hosted on Zoom, will feature short courses from NBR editors James Cavuoto, Jennifer French, Jeremy Koff, and Jo Jo Platt. The free morning sessions will feature short courses devoted to preparing a pitch deck, developing a financial model, attracting early-stage investment, and assessing the market opportunity.

Neurotech Reports announced it will offer a commercialization workshop for neurotech startups and established firms seeking to launch new products on July 8. The workshop, hosted on Zoom, will feature short courses from NBR editors James Cavuoto, Jennifer French, Jeremy Koff, and Jo Jo Platt. The free morning sessions will feature short courses devoted to preparing a pitch deck, developing a financial model, attracting early-stage investment, and assessing the market opportunity.

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…