Over the last two weeks, much of the real progress came through less eye-catching milestones: data serving label expansions, post-approval studies, feasibility results, and CMS payment expansions. Paired with new devices and functionalities going live, neurotech moved a little further into regulated care.
Yet the milestones most likely to reach readers came from two patient stories. Paradromics offered a window into the life of its first implanted participant, a woman in her sixties now using the device to hold full conversations with her grandchildren. Meanwhile, in non-invasive territory, the team at Synaptrix showed they can control a cursor with EEG alone.
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The first participant implanted with Paradromics' Connexus brain-computer interface has successfully used the device for real-time speech. The Michigan woman, in her sixties and living with motor neuron disease, chose her own words, answered open-ended questions, and spoke with her grandchildren on a phone call. According to the startup, every word directly reflected her selections, without corrections. The milestone comes three months after implantation as part of Paradromics' Connect-One feasibility study.
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Synaptrix Labs demonstrated real-time control of a computer cursor using its non-invasive EEG headset. The New York company pairs a dry-electrode headset with its in-house AI engine, which filters noise from scalp EEG to decode user intent with low latency. Synaptrix is building toward wheelchair and communication control as an affordable, surgery-free alternative to eye-tracking and implanted interfaces.
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Flow Neuroscience launched FL-100 in the US, the first FDA-approved at-home brain stimulation device for depression. The prescription headset delivers transcranial direct current stimulation, a low, steady electrical current, to the dorsolateral prefrontal cortex, a brain region often underactive in depression. Approved through the FDA's full premarket approval pathway, FL-100 is indicated for adults with moderate to severe major depression as a standalone or add-on treatment. The headset has already been used by more than 55,000 people in Europe.
NeuroHarmonics launched its first clinical trial, evaluating its non-invasive deep-brain ultrasound platform in essential tremor. The study follows regulatory clearance from the UK's MHRA and a favorable ethics opinion, and will enroll adults whose tremor is inadequately controlled by medication. Focused ultrasound can reach deep brain structures that surface stimulation cannot. NeuroHarmonics is designing for accessibility, removing the MRI guidance and fitted mask that focused ultrasound normally requires.
Nyxoah reported that its ACCCESS pivotal study met its primary safety and efficacy endpoints in patients with complete concentric collapse, a form of obstructive sleep apnea excluded from competing nerve-stimulation therapies. Across 47 patients, Genio achieved a 77.2% responder rate on the apnea-hypopnea index, with no device-related serious adverse events. The leadless, battery-free implant stimulates both sides of the hypoglossal nerve to keep the airway open during sleep. Nyxoah is preparing an FDA submission to expand Genio's US indication and has separately begun its BREATHE post-approval study.
ONWARD Medical performed the first implant in EIGER, a new feasibility study of its ARC-IM system for restoring mobility after spinal cord injury. The implanted device delivers targeted spinal cord stimulation to support standing and walking. EIGER is the first ONWARD mobility study to include people with subacute injuries, sustained within six weeks of the procedure. The procedure took place at Lausanne University Hospital under the supervision of co-founder Dr. Jocelyne Bloch.
Neuro Event Labs received CMS approval for a New Technology Add-on Payment for Nelli, its AI-powered seizure monitoring system. From October 2026, hospitals can receive up to $975 per eligible Medicare inpatient case. Nelli uses automated video and audio analysis to detect and characterize seizures with a motor component, reducing reliance on staff-intensive review. The payment follows its November 2025 FDA clearance and supports broader adoption of the first FDA-cleared video-based seizure monitoring device in the US.
Kneu Health launched a passive Parkinson's monitoring tool that runs on a patient's Apple Watch. It adds 24/7 tracking of tremor and, for the first time, dyskinesia, the involuntary movements caused by Parkinson's medication. The watch data complements motor and cognitive tests in Kneu's smartphone app, giving clinicians a continuous view of symptoms between appointments. The tool is FDA-cleared, MHRA-registered, and live across ten NHS organisations, with 79% of eligible patients adopting it within two weeks.
NeuroBionics received a Phase II NSF SBIR grant to advance its IO Fiber platform, a multifunctional neural probe for researchers. The flexible fiber combines electrical and optical recording and stimulation with localized fluid delivery, replacing several separate probes in complex experiments. The funding supports manufacturing scale-up and commercialization. The Cambridge company is also developing the underlying bioelectronic-fiber technology toward less invasive therapies such as deep brain stimulation.
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