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THE TAPE
Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register
The Directory // Neurology & Neurotech

Neurology & Neurotech

Neuromodulation, brain-computer interfaces, stroke and neurodiagnostics. 23 companies listed.

Boston, MA  ·  Est. 2017  ·  Unknown  ·  Submission pending

Developing a non invasive brain stimulation device patients can use at home, in FDA pivotal trials for major depressive disorder with pilot work in Alzheimer's and Parkinson's disease.

St. Louis, MO  ·  Est. 2024  ·  Seed  ·  Breakthrough designation

Washington University spinout developing V-Link, a noninvasive ear-worn vagus nerve stimulator to reduce cerebral vasospasm after aneurysmal subarachnoid hemorrhage. Breakthrough Device designation granted June 30, 2026.

San Francisco, CA  ·  Est. 2020  ·  Unknown

Developing a neurostimulation implant for hearing loss in patients who no longer benefit from hearing aids but are not candidates for cochlear implants. Came out of Stanford Biodesign.

Cambridge, MA  ·  Est. 2021  ·  Series A  ·  $60M+ raised

Develops implantable brain-computer interfaces made from Fleuron, a soft polymer intended to reduce scarring and signal drift. In early human trials; no FDA marketing authorization yet.

Boston, MA  ·  Series B  ·  $132M+ raised  ·  510(k) cleared

Beacon Biosignals makes the Waveband EEG headband and AI sleep-staging software, and sells brain-function biomarkers to drug developers.

Boston, MA  ·  Est. 2014  ·  Series C  ·  Breakthrough designation

Developing eShunt, an endovascular cerebrospinal fluid shunt for normal pressure hydrocephalus placed through femoral venous access. Breakthrough-designated and in the STRIDE trial ahead of a PMA.

Cambridge, MA  ·  Est. 2016  ·  Series C  ·  Breakthrough designation

Builds Spectris, a prescription home-use device that delivers gamma frequency light and sound stimulation for Alzheimer's disease. The device holds Breakthrough Device designation and is in the HOPE trial ahead of an FDA submission.

London, UK  ·  Series A  ·  $102.5M raised  ·  Submission pending

CoMind is developing CoMind One, a non-invasive optical monitor for cerebral blood flow, autoregulation and intracranial pressure in critical care.

Mountain View, CA  ·  Seed  ·  Breakthrough designation

Cordance Medical is developing a focused ultrasound system that temporarily opens the blood-brain barrier for drug delivery and liquid biopsy in brain tumors.

Malmö, Sweden  ·  Est. 2016  ·  Series A  ·  PMA approved

Flow Neuroscience makes a home-use tDCS headset paired with a behavioral therapy app for depression. It has sold in the UK and Europe since 2019.

Tempe, AZ  ·  Est. 2017  ·  Series D+  ·  $214M raised  ·  510(k) cleared

Sells GammaTile, a bioresorbable brachytherapy implant placed in the resection cavity during brain tumor surgery. Cleared under 510(k) with product code KXK and used at more than 150 US cancer centers.

Austin, TX  ·  Est. 2007  ·  Public  ·  PMA approved

Formerly MicroTransponder. Sells the Vivistim Paired VNS System, an implanted vagus nerve stimulator approved under PMA P210007 for upper limb rehabilitation after chronic ischemic stroke. Listed on Nasdaq as MOBI in May 2026.

Netanya, Israel  ·  Unknown  ·  PMA approved

Neurolief makes wearable multi-channel neuromodulation headsets for home use, including Relivion MG for migraine and ProlivRx for depression. It has offices in Netanya, Israel and Coral Springs, Florida.

Pleasanton, CA  ·  Acquired  ·  De Novo granted

Makes Nidra, a pair of wearable units that stimulate the peroneal nerves to reduce symptoms of moderate to severe restless legs syndrome in adults whose medication has stopped working. Resmed acquired the company in June 2026.

Galway, Ireland  ·  Series A  ·  €44.5M raised  ·  510(k) cleared

Makes aspiration and access catheters for mechanical thrombectomy in ischemic stroke, including the 0.088-inch Millipede88.

Irvine, CA  ·  Series A  ·  Submission pending

Spiro Medical is developing an implantable spinal nerve stimulator to reduce symptoms in severe, uncontrolled asthma.

New York, NY  ·  Series D+  ·  $345M raised  ·  Submission pending

Synchron builds the Stentrode, an endovascular brain-computer interface implanted through the blood vessels so people with paralysis can control digital devices.

Boston, MA  ·  Est. 2018  ·  Unknown

Developing implantable closed loop neuromodulation devices that sense and stimulate brain activity, aimed at improving deep brain stimulation for Parkinson's disease, essential tremor and epilepsy.

Kitchener, ON, Canada  ·  Est. 2016  ·  Series A  ·  510(k) cleared

Makes a very small forward looking camera on a catheter for imaging inside blood vessels during neurovascular procedures.

San Francisco, CA  ·  Est. 2018  ·  Acquired

Developed a device that cools the brain to limit damage during a stroke. Acquired by Penumbra.

Paris, France  ·  Est. 2012  ·  Series D+  ·  510(k) cleared

Builds self-balancing walking exoskeletons for rehabilitation clinics and for personal use by people with spinal cord injury.

San Francisco, CA  ·  Est. 2019  ·  Unknown

Makes a wearable headband that uses EEG sensors and machine learning to detect a stroke as it starts and alert emergency services.

Boston, MA  ·  Est. 2018  ·  Unknown  ·  510(k) cleared

Sells a navigation and robotics platform that uses computer vision for image guidance in minimally invasive procedures. The Zeta Navigation System and Zeta TMS Navigation System are FDA cleared.

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