Evidence
Built on evidence.
The science behind NVT BVS is published and peer reviewed, and the record is growing.
24/7
continuous recording, at home, at work, and in sleep
150+
patients with sub-scalp electrode experience
3 yrs
the recording life a single implant is designed for
The record, year by year.
2020
2020Peer reviewedJournal of Clinical Neurophysiology
Recording from under the scalp, validated against electrodes inside the skull.
The founding validation, compared with simultaneous intracranial EEG during the same seizures.
2020
2020MilestoneAmerican Epilepsy Society
Co-founder recognized for clinical science.
Dr. Ruben Kuzniecky receives the AES Research and Recognition Award.
2021
2021Peer reviewedJournal of Neuroscience Methods
Automated seizure detection, benchmarked against expert review.
Tested on sub-scalp recordings against blinded expert readers.
2023
2023MilestoneNational Institutes of Health
NIH Blueprint MedTech backs the platform.
Federal funding and access to NIH research resources.
2023
2023MilestoneUniversity of Colorado
Preclinical: eight weeks implanted, no observed adverse effects.
Clean recordings throughout, and the device removed exactly as planned.
2024
2024Peer reviewedNew England Journal of Medicine
The field's leading journal takes up the question.
Co-founder Dr. Daniel Friedman co-authors the NEJM review of wearable digital health technology for epilepsy.
2024
2024Peer reviewedJournal of Clinical Neurophysiology
From brief snapshots to months of recording.
Co-founder Dr. Ruben Kuzniecky and F. Lado chart what continuous EEG changes about the disease.
2024
2024MilestoneEpilepsy Foundation
One of two companies recognized nationally.
Selected at the Foundation's annual innovation competition.
Regulatory pathway
A defined regulatory path.
NVT is pursuing the FDA De Novo pathway, which provides a route for novel low-to-moderate-risk medical devices without a legally marketed predicate. Our completed pre-IDE meeting with the FDA informed this pathway, and NVT is preparing the pivotal clinical trial that will support the submission.
NVT BVS is an investigational device today and is not approved for sale in any jurisdiction.
Frequently asked questions
How was recording from under the scalp validated?
A 2020 study in the Journal of Clinical Neurophysiology recorded both at once in the same patients, during the same seizures, and compared single-channel subgaleal EEG with intracranial EEG for seizure identification.
How was automated seizure detection tested?
A 2021 study in the Journal of Neuroscience Methods benchmarked automated ictal detection on subgaleal recordings against blinded expert review, and found detection across the seizure types studied.
Has the device been implanted and tested?
Yes. An eight-week preclinical trial at the University of Colorado Veterinary School recorded clean EEG throughout with no observed adverse effects, and the device was removed exactly as planned.
Is NVT BVS approved for sale?
No. NVT BVS is an investigational device and is not approved for sale. NVT is preparing for a pivotal clinical trial and an FDA De Novo submission, the pathway informed by our completed pre-IDE meeting.
The technology this evidence supports.