Forest Devices announced today that it received FDA 510(k) clearance for its SignalNED Model RE system for brain state analysis. This marks the first FDA clearance for the company, which won MedTech Innovator’s 2019 accelerator competition. The Pittsburgh, Pennsylvania-based company also featured on our 2020 list of startups you need to know. Forest Devices, founded […]
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 neurotech companies you need to know
+ Brain breakthroughs: Aprinoia Therapeutics’ harnesses AI and strategic partnerships to propel neurodegenerative disease research
+ 7 brain-computer interface companies you need to know
+ Natalizumab and PML: The complex dance of benefit and risk for MS
Latest Neurological News
GE HealthCare picks up FDA nod for new brain imaging tool for Alzheimer’s
GE HealthCare announced today that the FDA has cleared its new imaging tool to assess people with potential Alzheimer’s disease. The FDA 510(k) clearance covers performing Centiloid scaling for positron emission tomography (PET)-based amyloid imaging analysis and quantification. Available with MIMneuro – a vendor-neutral solution – the new Centiloid scale tool can help clinicians more […]
Neuralink wins FDA breakthrough nod for vision-restoring implant
Neuralink announced on social media that it received FDA breakthrough device designation for its vision-restoring Blindsight implant. On the social media platform X (formerly Twitter), the Elon Musk-backed brain-computer interface (BCI) venture wrote: “We have received Breakthrough Device Designation from the FDA for Blindsight. Join us in our quest to bring back sight to those […]
Medtronic unveils novel approach to studying adaptive deep brain stim for Parkinson’s
Medtronic today announced the publication of its novel approach to studying adaptive deep brain stimulation (aDBS). The approach was studied in the Nature Portfolio of journals’ npj Parkinson’s Disease. It outlines the medtech giant’s adaptive DBS algorithm for personalized therapy in Parkinson’s disease (ADAPT-PD). The global, multi-center, prospective, single-blind, randomized crossover study looks at the […]
InspireMD submits carotid stent for FDA premarket approval
InspireMD (Nasdaq:NSPR) announced today that it submitted a premarket approval (PMA) application to the FDA for its CGuard system. The company designed the CGuard Prime carotid stent system for the treatment of carotid artery stenosis. It based its PMA application on positive one-year data from the company’s C-GUARDIANS pivotal clinical trial. The trial evaluated the […]
Penumbra wins CE mark for computer-assisted thrombectomy tech
Penumbra (NYSE:PEN) announced today that it received CE mark approval for its computer-assisted vacuum thrombectomy (CAVT) technologies. The Lightning Flash 2.0 and Lightning Bolt 7 offerings from the Alameda, California-based company both picked up European approval. Penumbra said approval makes its Lightning products the only CAVT systems available in Europe. The company’s latest offerings set […]
Synchron announces first use of BCI with Amazon Alexa
Synchron today announced the first use of Amazon’s Alexa by a patient implanted with its brain-computer interface (BCI). The first pairing of Alexa with the Synchron BCI comes just weeks after the company linked its BCI with the Apple Vision Pro in July. Mark, a 64-year-old man with amyotrophic lateral sclerosis (ALS), used the combination […]
GT Medical Technologies brings in $35M for bioresorbable radiation tile
GT Medical Technologies, maker of the GammaTile bioresorbable collagen tile, announced that it secured a $35 million venture loan facility. Within the loan facility, Horizon Technology Finance Corporation, an affiliate of Monroe Capital, funded an initial $15 million. In addition to Horizon, the company has backing from a number of top-tier investors. That list includes MVM […]
MicroVention rebrands to Terumo Neuro
MicroVention, a Terumo subsidiary, today announced its official rebranding to Terumo Neuro, effective immediately. The company says the name change signifies a new chapter in its evolution while maintaining its commitment to neurovascular care. Aliso Viejo, California-based Microvention — founded in 1997 and acquired by Terumo in 2006 — develops a number of technologies for […]
Neuromod tech developer Neuspera appoints first COO
Neuspera Medical announced today that it appointed Bunty Banerjee as its first chief operating officer (COO). The San Jose, California-based sacral neuromodulation (SNM) technology developer said Banerjee will lead activities in R&D and operations while working closely with all other functions. His appointment comes as the company completes a new FDA submission for its neuromodulation […]
Zeto inks partnership with Firefly Neuroscience
Zeto has formed a partnership with Firefly Neuroscience that boosts the distribution of Zeto’s FDA-cleared EEG headset devices. The strategic partnership, announced yesterday, makes Buffalo, New York–based Firefly a non-exclusive distributor of Santa Clara, California–based Zeto’s headset. The collaboration also includes the integration of Firefly’s proprietary Brain Network Analytics (BNA) technology with the EEG platforms, […]
