Newronika announced today that it received CE mark approval for its AlphaDBS device for treating Parkinson’s disease. AlphaDBS, the company’s next-generation, closed-loop deep brain stimulation (DBS) system treats other neurological diseases, too. It dynamically adjusts stimulation based on real-time brain signals. Newronika joins Medtronic in offering an adaptive DBS system after the medtech giant began […]
Bioelectronic Medicine
Sooma wins FDA IDE for neuromod tech that treats depression
Sooma Medical announced today that it received FDA investigational device exemption (IDE) for its transcranial direct current stimulation (tDCS) device. The company can now begin a pivotal study of the medical device with the IDE. Helsinki, Finland–based Sooma designed the tDCS device to treat depression through portable neuromodulation. Worn as a cap, the device uses a […]
Onward picks up grants to support spinal cord stim for Parkinson’s
Onward Medical today announced two new grants to support early clinical feasibility studies for its investigational ARC-IM system. The studies aim to evaluate the ARC-IM spinal cord stimulation (SCS) system’s potential to help people with Parkinson’s disease. Researchers Dr. Jocelyne Bloch and Grégoire Courtine of NeuroRestore received a $1 million grant from the Michael J. […]
Onward reports positive spinal cord stim results for ARC-EX
Onward Medical today announced positive study results from an evaluation of its ARC-EX spinal cord stimulation therapy system. Results from the investigator-sponsored Pathfinder 2 study, published in Neuromodulation: Technology at Neural Interface, detailed findings from one year of evaluations for people utilizing ARC-EX therapy. It showed that ARC-EX, combined with activity-based rehabilitation, delivered functional improvements […]
Medtronic wins first FDA nod for adaptive DBS for Parkinson’s
Medtronic announced today that the FDA approved its BrainSense adaptive deep brain stimulation (aDBS) platform. The company also received approval for its BrainSense Electrode Identifier (EI). Together, these technologies use a minimally invasive, surgically implanted neurostimulator to transmit electrical signals to specific parts of the brain affected by neurological disorders. They act as a sort […]
Salvia BioElectronics reports first migraine therapy implant in The Netherlands
Salvia BioElectronics has reported the first patient implanted with its ultra-thin implant for chronic migraine in The Netherlands. The first implant in the country took place at Erasmus MC in Rotterdam as part of a clinical study. Investigators are currently evaluating the technology in an ongoing study in Belgium, Australia and now The Netherlands, where […]
Neuromod developer NeuroPace announces $65M offering
NeuroPace (Nasdaq:NPCE) today announced that it intends to sell common stock in an underwritten public offering worth $65 million. Mountain View, California-based NeuroPace plans to grant underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock offered in the public offering as well. The company expects to […]
Newronika closes $14.1M Series B to support adaptive DBS
Newronika announced today that it closed a €13.6 million ($14.1 million) Series B round to support its deep brain stimulation (DBS) system. New investor Fondazione ENEA Tech e Biomedical led the financing round. Existing investors Indaco Venture Partners SGR, Innogest SGR, Wille Finance, TNBT Capital and F3F participated, too. The Series B adds to a […]
Cognito Therapeutics expands executive team to drive growth, reports positive neuromod data
Cognito Therapeutics today announced the appointment of four new executives to accelerate its growth and commercialization efforts. Cambridge, Massachusetts-based Cognito named Steve Worthy as its new chief business & financial officer, Dr. Robbert Zusterzeel as its chief clinical & regulatory officer, Deanna Angello as chief commercial officer and Pritesh Shah as chief strategy officer. The […]
Neuronetics prices $18M offering
Neuronetics (Nasdaq:STIM) announced today that it priced an underwritten public offering of common stock at approximately $18 million. The company intends to offer 8 million shares of common stock at $2.25 per share to total gross proceeds of about $18 million. That total excludes discounts and commissions and other offering expenses payable by the Malvern, […]
Newronika wins FDA IDE for adaptive deep brain stim tech
Newronika announced today that it received FDA investigational device exemption (IDE) for its deep brain stimulation (DBS) system. The IDE enables Newronika to initiate a pivotal U.S. clinical trial to evaluate the safety and efficacy of the adaptive DBS system. It could aid patients with movement disorders, including Parkinson’s disease. Milan, Italy-based Newronika said it […]
