MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

Home » FDA clears NeuroOne’s Evo sEEG electrode

FDA clears NeuroOne’s Evo sEEG electrode

By

NeuroOne_Logo (1)NeuroOne Medical Technologies (NMTC) announced that it received FDA 510(k) clearance for its Evo sEEG electrode technology.

Eden Prairie, Minnesota-based NeuroOne’s Evo sEEG electrode technology received clearance for temporary (less than 24 hours) recording, monitoring and stimulation of electrical signals at the subsurface level of the brain, according to a news release.

The Evo sEEG electrode represents the second FDA-cleared product from NeuroOne its Evo cortical electrode technology in November 2019. The company develops surgical care options for patients suffering from neurological disorders.

NeuroOne’s sEEG electrodes, contrary to cortical electrodes, provide a similar function at the subsurface level of the brain while using a much less invasive process as it does not require the removal of the top portion of the patient’s skull.

The company anticipates a launch of the Evo sEEG by the end of calendar year 2021, pending additional regulatory clearance for labeling that would enable longer-term use.

“This represents yet another critical milestone met by the Company as we continue to execute our strategy,” NeuroOne CEO Dave Rosa said in the release. “The next steps for the company are to expand the sEEG labeling for longer-term use, which we believe will be a key part of our commercialization strategy for the Evo sEEG electrode, and complete development of an sEEG ablation electrode/probe for ablation of brain tissue and permanently implanted stimulation electrodes for patients with chronic applications such as epilepsy, Parkinson’s disease and chronic back pain.”

In case you missed it

RSS From Medical Design & Outsourcing

  • Bringing motion to medicine: How Actuated Medical is innovating deep brain stimulation and more
    Actuated Medical is making electrode placement for deep brain stimulation easier and less traumatic. Nearly 16 years ago, Actuated Medical co-founder, President and CEO Maureen Mulvihill was working for a company making actuators that were the size of a grain of rice. While the company was focused on components, she wanted to help patients more.… […]
  • Elkem Silicones opens new medical silicone production facility
    Elkem Silicones announced today that it opened its new specialized facility for producing high-purity medical silicones. York, South Carolina-based Elkem held a grand opening on Sept. 28. Customers and local, state and federal officials attended the event, which featured a ribbon-cutting ceremony, facility tours and a reception. “Elkem’s investment in this highly specialized facility demonstrates… […]
  • Three considerations for reshoring your medical device components and assemblies
    Reshoring medical devices — moving production back to the United States — requires strategic and complex navigation. John Banks and Richard Landry, Beacon MedTech Solutions Reshoring is a topic of conversation with almost every biopharma, life sciences and medical company currently outsourcing production of thermoplastic or silicone parts, products and assemblies to overseas molders. Just… […]
  • How Medline maintains quality while innovating and growing
    Medline President of Quality and Regulatory Affairs Lara Simmons offers insight into innovation and quality as the company grows. When Lara Simmons joined Medline Industries in 1991, she began by performing packaging validations. At the time, Medline was bringing in $250 million in sales per year, and the company’s quality assurance team had only about… […]
  • How this inside-out vascular access system simplifies catheter placement
    Bluegrass Vascular Technologies is making catheter placement procedures for dialysis and chemotherapy easier and safer using inside-out technology, explains CEO and President Gabi Niederauer. Bluegrass Vascular Technologies has figured out a way to make a catheter sheath go inside the body and back out for easy catheter placement in standard access procedures. The San Antonio,… […]
  • 6 Steps for Winning at Life Sciences Bid Management
    By Bob Steller, Industry Principal – Life Sciences Discover the secret to success for planning, executing—and winning—profitable bids Did you know that 85% of revenue in the medical technology market comes through bids and tenders? For Life Sciences companies like yours, one key to building and expanding your business is mastering the art and science… […]
  • Digital Pump Customization: Unlocking the True Potential of BLDC Motors
    By using advanced electric motors, a variety of motor and pump parameters can be customized to individual customer needs. It is becoming increasingly more valuable to be able to monitor all electronic components on board medical devices. By taking advantage of the full capabilities and digital customization of brushless direct current (BLDC) motor controllers, pumps… […]
  • Why Automate? Justification and Impact Explained
    Do you want to integrate automation into your manufacturing process but you’re unsure where to start? Maybe your biggest hurdle is justifying the costs associated with the change. Effectively communicating the reasons why and the ROI to all stakeholders in this major shift is a necessary starting point. Justifying the Need to Automate Increased production… […]
  • In vivo electroporation is an engineering solution for drug and gene delivery
    Why the new buzz about an old technique? Harness the potential of an existing technology for modern medicine. Daniel Friedrichs, Minnetronix Medical Reversible electroporation is the use of an electric field to open pores in a cell wall, allowing transport of drugs, DNA or other “cargo” into a cell — in particular, allowing delivery of… […]
  • FDA and VA Ventures Innovation Institute partner on new medical device testing tools
    The Department of Veterans Affairs’ VA Ventures Innovation Institute in Seattle will host up to a dozen FDA staffers in a new collaboration to develop and share new tools for medical device testing safety and efficacy. The agencies intend to provide developers of devices and new technology with off-the-shelf tools that can help streamline regulatory… […]
  • How Boston Scientific is managing labor shortages with cobots and Spanish
    Boston Scientific (NYSE: BSX) executives said two labor-shortage strategies are paying off in a big way for the medical device maker, which has around 41,000 employees across the globe. Collaborative robotics and Spanish-speaking shifts are helping Boston Scientific deal with labor shortages in the U.S. and elsewhere. That’s according to Global Operations EVP Brad Sorenson… […]