The FDA shaped the biggest stories this fortnight. CorTec earned a second Breakthrough Device Designation, extending its implant from stroke rehabilitation into thought-based communication. Paradromics won approval to connect its BCI to the laptops and phones patients already own. Both decisions show the FDA engaging with the mission of turning brain-computer interfaces into tools of daily life.
Away from BCI, the fortnight saw steady progress across imaging and modulation platforms. Axoft released a new imaging polymer, Optohive launched its wearable fNIRS scanner, and Merge Labs and NeuroHarmonics both advanced ultrasound approaches. On the measurement side, Empatica cleared its Parkinson's monitoring platform, while Cumulus published usability data in ALS and FTD. Yesterday, Atlas rounded off the window by announcing its first EEG wearable.
Merge Labs signed a multi-year licensing agreement with Butterfly Network to build ultrasound-based brain-computer interfaces. The deal gives Merge access to Butterfly's Poseidon ultrasound-on-chip technology, with Butterfly serving as its exclusive chip partner in exchange for upfront payments, hardware commitments, and future royalties. Butterfly has similar agreements with Midjourney and Forest Neurotech (which shares a CEO with Merge). Merge, co-founded by Sam Altman and launched in January with $252M, is pursuing a non-invasive interface that reads and modulates brain activity with ultrasound.
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Paradromics received FDA approval to connect its investigational Connexus brain-computer interface to patients' own laptops, tablets, and phones. Until now, the implant worked only with a company-provided computer. The approval moves the platform toward the technology patients already use daily. It applies within the ongoing Connect-One feasibility study, the first for a fully implantable BCI aimed at restoring speech.
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CorTec received its second FDA Breakthrough Device Designation for its Brain Interchange system, this one covering device control for people with non-progressive quadriplegia. The fully implantable device records neural activity and delivers adaptive stimulation in a closed loop. The same implant can now both aid motor recovery and let users control a computer using thoughts. The first designation, granted in April, covered stroke motor rehabilitation. CorTec is already running a stroke study at the University of Washington, where three participants received the implant, and one used it to control a computer.
Axoft introduced Fleuron WISE, a new soft polymer that becomes optically invisible in water by matching its refractive index. The material is built for super-resolution imaging of biological samples, reducing the distortions that normally blur high-resolution views of water-immersed tissue. It extends the Fleuron portfolio that underpins Axoft's brain implants, where the same brain-soft material improves biocompatibility and signal stability. WISE is commercially available now. Axoft will present results at the Materials Research Society meeting in December.
NeuroHarmonics revealed the first public details of the neuromodulation platform it has been developing. The team develops a device that uses transcranial ultrasound to reach deep brain circuits without surgery. The London company, a spin-out of University College London, positions the system on accessibility, requiring no hair preparation, no mask, and no scanner, in contrast to the setup focused ultrasound normally demands. Focused ultrasound can target millimeter-scale regions in the deeper structures that surface stimulation cannot reach.
Fareon published a new paper linking biological markers to its Microtesla Magnetic Therapy, a non-invasive treatment delivered through low-intensity magnetic fields. In the exploratory study, participants with Long COVID brain fog showed plasma-protein changes tied to reduced inflammation, tissue repair, and lower predicted brain age, alongside earlier-reported gains in memory and processing speed. Fareon, formerly Humanity Neurotech, frames the results as early evidence that magnetic fields could treat brain disorders by targeting neuroinflammation.
Optohive made its HiveOne wearable fNIRS system commercially available to researchers. The ETH Zürich spin-out's headset uses functional near-infrared spectroscopy, an optical method that measures brain activity through changes in blood oxygenation, paired with proprietary silicon photomultiplier sensors to deliver lab-grade data in a lightweight, fully wireless form. It is built for real-world settings that traditional imaging cannot easily reach. Beyond research, Optohive is developing the platform toward longitudinal brain monitoring for conditions such as ADHD and stroke rehabilitation.
Empatica received FDA 510(k) clearance for its Health Monitoring Platform for Parkinson's, its 12th FDA clearance. The system pairs Empatica's clinical-grade wearable with a patient app and clinician portal to continuously track Parkinson's symptoms, including tremor, slowness of movement, involuntary movements, sleep, and medication compliance. It builds on the company's 2025 acquisition of PKG Health, folding PKG's established Parkinson's measures into Empatica's wearable platform.
Atlas opened pre-orders for the Atlas 1.0 after five years of development. Worn on the hairless skin behind the ear, the patch combines EEG with motion, skin conductance, and voice-vibration sensing to estimate three measures: Presence, Stress, and Energy Burn. Starting at $499 with a $29.99 monthly subscription, the San Francisco company is making a direct play for the mainstream wearable market held by Oura and Whoop, using a subscription model and simplified scores rather than clinical framing. Atlas has raised $24 million and was selected for the NBA Launchpad programme earlier this year.
Cumulus Neuroscience published results from its CNS-102 study in Scientific Reports, showing its at-home NeuLogiq platform can be used for people living with ALS and frontotemporal dementia. Over an eight-month protocol, the platform combined a wireless EEG headset with tablet-based cognitive tasks, with 82% of ALS participants rating it easy to use despite significant motor and cognitive impairment. The study is the first to combine at-home EEG and multi-domain cognitive assessment in this population.
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