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 […]
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.
🧠 Narrow your focus with these categories:
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
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 […]
SyntheticMR wins FDA clearance for 3D brain scanner
SyntheticMR announced today that its next-generation 3D imaging solution with isotropic resolution received FDA 510(k) clearance. Linköping, Sweden-based SyntheticMR said in a news release that the regulatory nod “marks a significant advancement in quantitative MRI technology.” The company says its SyMRI 3D offering provides “unprecedented resolution and accuracy in brain imaging.” Approval marks the second […]
Protembis raises $32.6M, adds Shockwave exec to board
Cardiovascular medical device maker Protembis announced today that it completed a $32.6 million (€30 million) Series B financing round. The Aachen, Germany-based company plans to use the funds to support enrollment for its PROTEMBO FDA investigational device exemption (IDE) trial. The trial evaluates the company’s embolic protection technology. European VC investors, including Segulah Medical Acceleration, […]
NeuroOne begins neuroablation system launch in U.S.
NeuroOne Medical Technologies (Nasdaq:NMTC) announced today that it initiated a limited commercial launch for its OneRF ablation system. The Eden Prairie, Minnesota–based company said its initial rollout comes earlier than it previously expected. It picked up FDA 510(k) clearance for the OneRF system just over three months ago in December 2023. Indications cover the creation […]
Fast Company names 10 medtech companies as most innovative of 2024
Fast Company recently named 10 medical device companies as some of the most innovative companies of 2024. Each year, Fast Company releases its list of the world’s most innovative companies. The list covers 58 industries and sectors, ranging from advertising to video. Companies on the “Most Innovative” list apply to be included, and then Fast […]