invasive · single-unit · investigational
Fleuron
By Axoft
Identity
- Manufacturer
- Axoft
- Model number
- —
- Codename
- —
- Aliases
- Axoft Fleuron, Fleuron iBCI
- Generation
- —
- Country of origin
- US
- Released
- —
- Announced
- —
- Discontinued
- —
- Status
- investigational
Classification
- Invasiveness
- invasive
- Modalities
- single-unit, multi-unit, LFP
- Primary modality
- single-unit
- Direction
- read-write
- Categories
- medical-implant, research-grade
- Form factor
- intracortical-implant
- Use cases
- intracortical recording for BCI research, intraoperative cortical / language / seizure-onset mapping during tumor resection, future clinical trial in TBI for measuring recovery and consciousness
- Target users
- neuroscience-researcher, neurosurgeon, patient-paralysis
Electrodes
- Total channels
- —
- Recording channels
- —
- Reference channels
- —
- Electrode type
- intracortical-soft
- Material
- fleuron-polymer
- 10-20 positions
- —
- Requires gel
- No
- Requires saline
- No
- Prep time
- —
- Reusable
- No
- Disposable
- No
Stimulation
- Capable
- Yes
Connectivity
- Protocols
- —
- Bluetooth
- —
- Bluetooth profiles
- —
- Concurrent mode
- —
- Encryption (transit)
- —
- Pairing methods
- —
- Cloud sync
- —
- Offline recording
- —
Power
- Sources
- —
- Battery life (active)
- —
- Charging port
- —
- Charging time
- —
- Battery replaceable
- —
- Notes
- —
Physical
- Weight
- —
- Dimensions
- —
- Materials
- fleuron-polymer
- Sizes
- —
- Head circumference
- —
- Operating temp
- —
Compute
- Has onboard computer
- Yes
- Operating systems
- —
- Primary OS
- —
- Edge ML accelerator
- —
- Root access
- —
- App sandbox
- —
- 3rd-party apps allowed
- —
- Notes
- Integrated circuit for on-device signal processing and bidirectional communication.
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
- No
- Open source
- No
- Languages
- —
- Web Bluetooth
- No
- Raw sample access
- Yes
- BCI paradigms
- —
- 3rd-party integrations
- —
- Docs
- —
Capabilities
- Attention / focus
- —
- Meditation / calm
- —
- Neurofeedback
- —
- Meditation coaching
- —
- Sleep tracking
- —
Regulatory & clinical
- FDA status
- investigational-device-exemption
- CE mark
- No
- Certifications
- —
- Prescription required
- Yes
- Pediatric approved
- No
Pricing & availability
- MSRP
- $0
- Current price
- —
- Subscription
- —
- Warranty
- —
- Return policy (days)
- —
- Where to buy
- —
Editor’s take
In favor
- Designed for chronic stability
- Could outlast Utah arrays by years
- $55M Series A (Apr 2026) supports clinical scale-up
Against
- Investigational only — no FDA-cleared product yet
- Commercial availability targeted for 2028
Sources & provenance
- Axoft — official site
- Axoft — $55M Series A press release
- MassDevice — Axoft completes first human cases
- medRxiv — Clinical translation of Fleuron probes
- Harvard OTD — Soft, safer brain implants
Last reviewed