semi-invasive · ECoG · clinical-trial
Layer 7 Cortical Interface
Identity
- Manufacturer
- Precision Neuroscience
- Model number
- Layer 7-T
- Codename
- —
- Aliases
- Layer 7-T, Layer 7 Cortical Electrode
- Generation
- —
- Country of origin
- US
- Released
- Announced
- —
- Discontinued
- —
- Status
- clinical-trial
Classification
- Invasiveness
- semi-invasive
- Modalities
- ECoG, LFP
- Primary modality
- ECoG
- Direction
- read-write
- Categories
- medical-implant, diagnostic, communication-aac, prosthetic-control
- Form factor
- ecog-grid
- Use cases
- intra-operative cortical mapping, temporary recording, monitoring, and stimulation of cortical electrical signals, BCI for motor and speech restoration (chronic variant under IDE)
- Target users
- neurosurgeon, neurologist, neuroscience-researcher, patient-spinal-cord-injury, patient-stroke, patient-als, patient-paralysis
Electrodes
- Total channels
- 1024
- Recording channels
- 1024
- Reference channels
- —
- Electrode type
- subdural-grid
- Material
- thin-film-polyimide, platinum
- 10-20 positions
- —
- Requires gel
- No
- Requires saline
- No
- Prep time
- —
- Reusable
- No
- Disposable
- Yes
Signal acquisition
- Sampling rate
- —
- ADC resolution
- —
- Notch filters
- —
- Onboard artifact rejection
- —
Stimulation
- Capable
- Yes
Connectivity
- Protocols
- —
- Bluetooth
- —
- Bluetooth profiles
- —
- Concurrent mode
- —
- Encryption (transit)
- —
- Pairing methods
- —
- Cloud sync
- —
- Offline recording
- —
Power
- Sources
- wired-usb
- Battery life (active)
- —
- Charging port
- —
- Charging time
- —
- Battery replaceable
- —
- Notes
- Powered by external recording equipment via the headstage.
Physical
- Weight
- —
- Dimensions
- —
- Materials
- thin-film-polyimide, platinum
- Sizes
- —
- Head circumference
- —
- Operating temp
- —
Compute
- Has onboard computer
- No
- Operating systems
- —
- Primary OS
- —
- Edge ML accelerator
- No
- Root access
- —
- App sandbox
- —
- 3rd-party apps allowed
- —
- Notes
- Passive array + headstage; computation runs on host-side equipment.
Software & data
- Mobile app
- —
- Cloud platform
- —
- Offline mode
- —
- Subscription required
- —
- Raw data access
- Yes
- Export formats
- —
- LSL support
- —
- Data ownership
- —
- Apps
- —
SDK & developer access
- Has SDK
- —
- Open source
- —
- Languages
- —
- Web Bluetooth
- —
- Raw sample access
- —
- BCI paradigms
- decoded-speech, cursor-control, click-decoder, motor-imagery
- 3rd-party integrations
- —
- Docs
- —
Capabilities
- Attention / focus
- —
- Meditation / calm
- —
- Neurofeedback
- —
- Meditation coaching
- —
- Sleep tracking
- —
Security
- Authentication factors
- —
- Per-user profiles
- —
- Requires account
- —
- Claiming methods
- —
- Ownership model
- —
- Activation lock
- —
- Remote lock
- —
- Remote wipe
- —
- Find my device
- —
- Notes
- —
Firmware & updates
- OTA supported
- —
- OTA transports
- —
- Update mechanism
- —
- Update channels
- —
- Rollback supported
- —
- Signed updates
- —
- Forced updates
- —
- User deferrable
- —
- Requires app companion
- —
- Average update frequency
- —
- Notes
- —
Regulatory & clinical
- FDA status
- 510k
- CE mark
- —
- Certifications
- —
- Prescription required
- Yes
- Pediatric approved
- —
Pricing & availability
- MSRP
- —
- Current price
- —
- Subscription
- —
- Warranty
- —
- Return policy (days)
- —
- Where to buy
- —
Media & links
- Official site
- precisionneuro.io
- Product page
- —
Editor’s take
In favor
- Highest channel count of any FDA-cleared cortical-surface array
- Non-penetrating — designed to be reversibly placed and removed without parenchymal damage
- 510(k) Class II (Layer 7-T) avoids the PMA burden borne by Class III BCIs
- Already used in 37+ clinical participants prior to clearance
Against
- 510(k) clearance applies only to temporary (<30-day) use; chronic variant still under IDE
- Surface ECoG signal is lower-resolution than penetrating intracortical recording
- Detailed amplifier / acquisition specs not publicly disclosed
Sources & provenance
- Precision Neuroscience — official site
- FDA 510(k) K242618 — Layer 7-T
- FDA 510(k) K242618 clearance letter (PDF)
- GlobeNewswire — Precision FDA clearance press release
- MedTech Dive — Precision FDA clearance coverage
Last reviewed