Digital neurology: the certified landscape 2026
Seizure detection, Parkinson's measurement, tremor stimulation, stroke AI and cognitive training: 46 neurology tools individually assessed against the FDA register, EUDAMED and the German DiGA directory.
Six findings
- Seizure monitoring went wearable. Seizure monitoring is now cleared on the wrist (Empatica EpiMonitor), on an Apple Watch (EpiWatch, 2025), on the upper arm (NightWatch+, from the Netherlands, 2025) and from video (Nelli, from Finland, 2025).
- The pace is high. 17 products received their own FDA decision since January 2025: 9 first authorisations and 8 updates.
- Parkinson's symptoms are measured at home, tremor is treated on the wrist. Parkinson's movement symptoms are measured with smartwatch and wrist software (NeuroRPM, StrivePD's Rune Labs system, Sine in 2026, Kneu Platform in 2025 and 2026) and, since August 2026, with Empatica's Parkinson's monitoring that incorporates the PKG monitor.
- Stroke AI is cleared module by module. Viz.ai (first De Novo 2018) and Brainomix (about a dozen module clearances since 2020) hold separate authorisations per function: large vessel occlusion, haemorrhage, subdural collections, hyperdensities, perfusion, ASPECTS.
- Cognition is a German DiGA field. NeuroNation MED (permanent) and memodio (provisional) are reimbursed for mild cognitive impairment, and neotivCare holds a class IIa mark for remote memory testing.
- Europe is less transparent than the US. Only 10 of 29 tools with an FDA record appear in EUDAMED.
Inside the report
- Executive summary and six findings
- Six segments, one nervous system: the market map
- What changed in 2025 and 2026: 9 first authorisations, 8 updates
- Six segment tables (Epilepsy and seizure monitoring; Parkinson's disease and tremor; Stroke: AI imaging and rehabilitation; Cognition and dementia; Multiple sclerosis and migraine; Concussion and brain injury) with FDA route, first and latest decision, reference numbers and verification level for every tool, plus EU class, notified body certificate evidence from EUDAMED and DiGA status
- Seven ways a neurology label can mislead
- What it means for pharma, insurers, care providers and primary care
- Method, verification levels and counting rules
What the full report adds to the free directory
Our free directory shows which tools are certified. The report shows the proof, and what it means.
- Evidence for every tool. The FDA record number, whether that record names this exact product, only its product family or only related hardware, the first and latest decision, and the notified body certificate evidence visible in EUDAMED. None of this is in the directory.
- What it means. The findings, the label traps, the white spaces in the market, and what the landscape means for pharma, payers, hospitals and clinicians.
- A document you can defend. Dated, externally reviewed and citeable in a strategy or procurement file. The organisation licence adds the Excel data file and the right to share it internally.
Order the full report
The full report (PDF, 13 pages) for one reader, personalised with your name and email on every page. For your own use, not for sharing.
Buy nowThe full report without personal marking, to share across your organisation, on your intranet and in internal presentations. Plus the Excel data file with all 46 tools, their FDA and EU references and certificate details, and an updated edition after six months.
Buy nowEverything in the organisation licence, plus a one-hour briefing with Prof. Koen Kas for your team on what the landscape means for your strategy.
RequestSee all certified brain and nerves tools in the free directory