Neurology

Paradromics won FDA clearance to test its Connexus BCI in two people with severe speech impairment. The 2026 trial will assess whether the device can decode speech in real time.

Ceribell’s algorithm analyzes EEG data collected through a headcap equipped with sensors can identify subclinical events unnoticed without continuous monitoring.

Medtech funding in 2025 sees a trend of fewer, yet larger deals with total funding of $3.6bn in Q1, $2.6bn in Q2 and $2.9bn in Q3, said LSI’s Nick Talamantes. In 2026, he expects a continued investor focus on more mature firms in areas of oncology, cardiology and neurology.

BrainsWay advanced its Deep TMS platform with an FDA labeling expansion for adolescent MDD and the launch of a 200-patient alcohol use disorder trial. The company posted strong Q3 growth and is pursuing new indications and at-home neuromodulation through its Neuralief investment.

Brain-computer interfaces advance toward trials and commercialization, Oura pushes for FDA-cleared blood pressure monitoring, and regulators weigh AI’s expanding role in mental health and diagnostics amid rising safety concerns.

Neurotech start-up Subsense started proof-of-concept studies in mice hoping to show by late 2026 that its nonsurgical, nanoparticle-driven brain-computer interface can read and stimulate neural activity and treat conditions such as Parkinson’s and epilepsy.

INBRAIN teamed up with Microsoft to apply agentic AI to analyze real-time brain data and eventually recommend programming like a “mini-neurologist,” said CEO Carolina Aguilar. It also seeks to enable scalable deployment of INBRAIN’s graphene-based technology and potential joined research.

Synchron raised $200m in series D funding to support pivotal trials in 2026 as well as commercialization of its Stentrode BCI. It also announced plans for a next-gen high-channel whole-brain interface and a new engineering hub in San Diego.

Viome Life Sciences accelerates its push into clinical diagnostics with studies in colorectal cancer and a major partnership with Microsoft to scale its molecular data analysis platform. Viome leverages RNA analysis and AI to detect disease at the molecular level and personalize preventive health.

The neuromodulation space is quickly filling with well-funded companies that have demonstrated early signs of success. However, with strategics seemingly unwilling to spend on novel technologies and pharma desperate to maintain its foothold in CNS, these companies will face many challenges.

After rolling out its hair-based autism diagnostic across the US, LinusBio is expanding into Japan and testing its “molecular movie” technology for ALS and other neurological disorders, aiming to deliver the first objective biomarkers in pediatric and neuropsychiatric care.

GT Medical says interim results from a clinical trial studying an innovative surgical procedure to treat brain tumors show promise for patients with newly diagnosed operable brain metastases.

Ceribell has filed patent-infringement claims against Natus alleging its BrainWatch EEG copies Ceribell’s headband and electrode innovations. Natus denies any intellectual property violations, saying the products serve different purposes.

At the MedTech Conference, the CEOs of Stryker, Hologic and Insulet said during a panel AI is now central to their business strategies, from creating new medical devices to streamlining workflows and administrative tasks. Stryker’s CEO Kevin Lobo plans a business unit focused on AI-enabled tech.

Rapid Nexus hopes its regenerative wound-healing system can ease the burden of diabetic foot ulcers and amputations. Backed by early clinical data and $3.8m in seed funding, the start-up is targeting the VA as a launchpad into a $6.5bn US market, with FDA clearance expected later this year.

Barcelona-based INBRAIN Neuroelectronics is partnering with Mayo Clinic to test whether its graphene-based cortical brain computer interface can enhance standard DBS in Parkinson’s, aiming for more precise adaptive therapy and improved gait outcomes.

The ShiraTronics Migraine Therapy System is a fully implantable neuromodulation platform purpose-built for head-based therapy. Unlike earlier off-label adaptations of spinal cord stimulators, it employs subcutaneous leads targeting the occipital and supraorbital nerves.

Microbot wins FDA nod for Liberty, Medtronic’s Hugo showed positive results in hernia repair in clinical studies, Obvius Robotics reports first human procedure with CERTA, Ronovo closes a $67m financing round with JJDC, and Quantum expands Epione CE marking to bone tumors.

Roche Diagnostics, Intuitive Surgical, Abbott and Edwards Lifesciences all acknowledge tariff headwinds, but stress preparedness, resilience and mitigation. Below is look at how management framed the impact in Q1 vs Q2 earnings calls.

The US FDA has published a list of recommendations for the safe use of hyperbaric oxygen therapy devices. While the therapy can be effective in treating several conditions, the agency says providers need to understand its potential risks.