Neurovalens announced today that it received FDA clearance for its Modius Stress device for treating anxiety and raised $2.65 million. Belfast, Northern Ireland–based Neurovalens designed Modius Stress to deliver non-invasive electrical stimulation. It stimulates key areas of the brain and nervous system without the need for surgically implanted electrodes. Modius Stress treats anxiety with a […]
Neurological
Welcome to MassDevice's Neurological Hub, your resource for the latest news in the neurological device space. Stay informed about the innovations and business news shaping the neurological industry.
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Neuromodulation/Neurostimulation | Bioelectronic Medicine | Pain Management | Brain-Computer Interfaces
Here are the top neurological device features from MassDevice and its sister publications (and scroll down to read the latest cardiology device news from MassDevice):
+ 7 brain-computer interface companies you need to know
+ Brain breakthroughs: Aprinoia Therapeutics’ harnesses AI and strategic partnerships to propel neurodegenerative disease research
+ Natalizumab and PML: The complex dance of benefit and risk for MS
Latest Neurological News
Synchron launches BCI registry with eyes on larger study, approval
Synchron announced today that it launched a community-centered registry to evaluate its brain-computer interface (BCI) technology. The company said its study aims to bring patients, carers and clinicians together to learn about BCI design and its benefits for people with limited mobility. Synchron designed its BCI technology to decipher the neural code of the brain, […]
FDA says recall of Cerenovus catheter guide sheaths is serious
The FDA deemed a recall of catheter guide sheaths from Johnson & Johnson’s Cerenovus Class I, the most serious kind. Medos International Sàrl, a J&J unit, recalled the Cerenovus Cerebase DA guide sheath and single-use neurovascular guide catheter on Feb. 2, 2024. The company distributed the devices — 1,343 in total — between June 14, […]
Brainlab, Fujifilm partner on neurosurgery navigation tech
Fujifilm Healthcare announced that it picked Brainlab to exclusively distribute its Arietta Precision ultrasound for neurosurgery applications in the U.S. The companies say Arietta Precision in conjunction with Brainlab’s surgical navigation system “becomes a powerful intraoperative neurosurgery solution.” It delivers advanced guidance and image quality for critical surgical decisions. Together, the end-to-end solution provides comprehensive […]
FTC wants more info on Boston Scientific, Axonics deal with closing timeline pushed back
Boston Scientific said today that the FTC requested additional information regarding its planned $3.7 billion acquisition of Axonics (Nasdaq:AXNX). In an SEC filing, Boston Scientific said both it and Axonics received requests from the FTC (U.S. Federal Trade Commission). The agency seeks to gather more information in connection with its review of the merger. Reports […]
Neurava raises $2.3M for epilepsy monitoring tech
Neurava announced today that it completed an oversubscribed seed financing round worth proceeds of $2.26 million. Indianapolis-based Neurava develops a novel wearable device for mitigating the risk of sudden unexpected death in epilepsy (SUDEP). The device monitors and alerts for seizures, cardiorespiratory dysfunctions, and the impending risk of SUDEP. Neurava says it’s unlike any other […]
WAT Medical wins FDA nod for OTC migraine preventative device
WAT Medical this week won FDA clearance for over-the-counter use of its HeadaTerm 2 wearable anti-migraine device. HeadaTerm 2 uses neuromodulation technology. It releases targeted electrical impulses that increase the pain tolerance of the wearer. It is FDA-cleared for the preventative treatment of migraine headaches and is available without a prescription in the U.S. HeadaTerm2 […]
Onward submits movement-restoring spinal cord stim tech to FDA
Onward Medical announced today that it submitted a de novo application to the FDA for the approval of its ARC-EX spinal cord stimulation system. The Eindhoven, the Netherlands-based company designed ARC-EX to restore function of upper extremities after spinal cord injury (SCI). If approved, the company says ARC-EX would become the first ever SCS therapy […]
FDA clears sleep monitoring software from Beacon Biosignals
Beacon Biosignals announced that it received FDA 510(k) clearance for its SleepStageML machine-learning software for sleep monitoring. SleepStageML automatically stages sleep from electroencephalogram (EEG) signals of clinical polysomnography (PSG) recordings. It aids in the diagnosis and evaluation of sleep and sleep-related disorders. Boston-based Beacon Biosignals said in a news release that the software could enable […]
Neuralink may be getting some scrutiny on Capitol Hill
Reuters reports that U.S. Rep. Earl Blumenauer (D-OR) issued a letter to the FDA questioning its inspection practices related to Neuralink. The report said Blumenauer asked why the FDA decided not to investigate the Elon Musk-backed brain chip maker before allowing in-human trials. This relates to repeated questions around animal practices at the company. Reuters […]
Synaptive Medical wins FDA nod for near-infrared fluorescence in robotic exoscope
Synaptive Medical announced today that it received FDA 510(k) clearance for its near-infrared fluoresence visualization module on its robotic exoscope. The Toronto-based company can now add its Modus IR module to the existing fluorescence offering on the 4K, 3D Modus X system. Modus IR bolsters the capabilities of the exoscope across all neurosurgical procedures, as […]