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 […]
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
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 […]
Precision Neuroscience launches new BCI study sites
Precision Neuroscience announced that it launched new clinical study sites at Mount Sinai Health System and the University of Pennsylvania. The company says the studies represent “a major step forward” as it aims to understand how the brain controls movement. It hopes to utilize the sites to advance its brain-computer interface (BCI) technology for people […]
FDA clears Neuronetics’ neurostim for adolescents with depression
Neuronetics (Nasdaq:STIM) announced today that it received FDA clearance for the use of its NeuroStar therapy for adolescent patients. Clearance covers the use of NeuroStar as an adjunct treatment of major depressive disorder (MDD) in adolescent patients aged 15-21. Neuronetics said clearance makes NeuroStar the first and only transcranial magnetic stimulation (TMS) treatment cleared for […]
Former Neuropace CEO takes the helm at Revamp Medical
Revamp Medical this week announced it appointed Mike Favet as CEO, effective immediately. Favet joins the Netanya, Israel–based heart failure congestion management company with more than 20 years of executive-level experience. He most recently was CEO of Neuropace, where he led a commercial expansion and took the company public in 2021. “Mike brings a distinguished […]
PTAB upholds two Medtronic patents in spat with Axonics, could go to jury trial
Medtronic announced today that the U.S. Patent and Trademark Office upheld many of its claims around two of its patents in its battle with Axonics (Nasdaq:AXNX). The office’s Patent Trial and Appeal Board (PTAB) affirmed the validity of many of the claims in two of Medtronic’s patents in the latest development in a long-running spat […]