6525--RFI - NeuroSignal Robotic Transcranial Doppler (raTCD)

Performance Work Statement (PWS)

This PWS outlines the requirements for acquiring, installing, configuring, and implementing a Robotic Transcranial Doppler (TCD) system to support advanced cerebrovascular monitoring at the Michael E. DeBakey VA Medical Center (MEDVAMC). The system aims to aid in the detection and trending of vasospasm, evaluation of cerebral autoregulation, real-time hemodynamic assessment, and microembolic signal (MES) surveillance.

• Procurement of one (1) Robotic TCD system, including console, robotic headset(s), 2 MHz transducers, fixation mechanisms, mobile cart, cables, and accessories.

• Provision of necessary software licenses/modules for automated vessel search, probe actuation, continuous signal optimization, spectral Doppler/M-mode visualization, emboli detection, waveform trending, and data export/reporting.

• Integration with VA-approved hardware and network environments, ensuring user authentication and secure storage on VA-controlled systems.

• Installation and configuration of the device, software, and network connectivity.

• Clinical training for physicians, technologists, and nursing staff.

• Initial technical support, warranty services, and implementation assistance.

• Robotic Automation: Automated vessel search, probe alignment, and continuous signal optimization with minimal operator intervention.

• Autonomous Reacquisition: Automatic probe adjustment after patient movement with alerts for signal loss/recovery.

• Continuous Monitoring Stability: Suitable for prolonged, hands-free monitoring in neuro-ICU environments.

• Ultrasound Modalities: Spectral Doppler and M-mode visualization, real-time hemodynamic measurements, and beat-to-beat waveform capture.

• Advanced Analytics: MES detection and logging, trend analysis, configurable alarms for vasospasm risk, and optional autoregulation indices.

• Data Management: Secure export to formats like PDF and CSV for clinical documentation; local storage on VA-approved systems (no offsite/cloud storage).

• Delivery & Installation: Within agreed timeframe after PO issuance; hardware/software installed and networked per VA requirements.

• Functionality: Successful bilateral insonation, continuous monitoring with autonomous reacquisition, operational MES detection, and verified export/report functions.

• Data Quality: Stable, reproducible Doppler signals suitable for trending and clinical decision-making.

• Training: Proficiency demonstrated in protocol setup and report generation.

• Support: Response to technical issues within 24 hours.

• Security Compliance: Full adherence to VA IT and security policies (VA Handbook 6500, HIPAA); no offsite data storage.

• Delivery: Within 45–60 days ARO (After Receipt of Order).

• Installation: Within 30 days of equipment receipt.

• Training: Within 30 days of installation.

• Warranty: 12 months from installation date.

• Compliance with VA Handbook 6500 and associated directives.

• No offsite storage or external hosting of VA data.

• Coordination with Information Security Officer (ISO) for cybersecurity review.

• Provision of documentation for VA IT approval (network diagrams, software versioning, etc.).

Solicitation / RFP / RFQ

This is a Special Notice of Intent (NOI) to award a Firm-Fixed-Price, Sole Source, Single-Award contract to NeuraSignal, Inc. for the purchase, installation, and training of the NeuraSignal NG2 Intelligent Ultrasound Robotic Transcranial Doppler (raTCD) System. The Department of Veterans Affairs (VA) intends to award this contract under the authority of FAR 6.302-1, citing NeuraSignal as the only known responsible source capable of providing the required fully automated robotic TCD platform.

• Automated robotic Doppler console

• Robotic TCD headset and fixation system

• Dual 2 MHz probes

• Mobile medical-grade cart

• Software licenses for automated vessel search, signal optimization, MES detection, waveform trending, and reporting

• Installation, configuration, and acceptance testing

• Clinical training for staff

• One-year warranty and technical support

• Specific Brand Name Items: NSC-NVGSYS2 (System), NSC-NGVSUB (App Subscription), NSC-WARRANTY (Service Warranty), NA-OST3 (Training Program), NA-OSTC (Clinical Education Plan), SHIP-NVG-US (Domestic Shipping)

• Contract Type: Firm-Fixed-Price, Sole Source, Single-Award

• Period of Performance: Delivery 45-60 days ARO, Installation within 30 days of receipt, Training within 30 days of installation, Warranty 12 months from installation.

• Place of Performance: Michael E. DeBakey VA Medical Center, Houston, TX.

• This notice is NOT a request for competitive quotes. A solicitation will not be issued.

• Interested parties may submit capability statements if they can demonstrate, with clear and convincing evidence, that they can provide the brand-name NeuraSignal system or satisfy the VA's full robotic TCD requirements.

• Responses must include Business Size and Socioeconomic Status, UEI, SAM.gov registration status, manufacturer authorization evidence, and technical documentation meeting PWS specifications.

• Responses Due: Submit via email to Shasta Britt (shasta.britt@va.gov) by the date specified on the announcement page.

• This is a sole source notice. The government will only consider competition if future responses demonstrate that competition would be advantageous and all brand-name specifications can be met.

• NAICS Code: 334510 (Electromedical and Electrotherapeutic Apparatus Manufacturing), Size Standard: 1,350 employees.

• PSC Code: 6525 (Imaging Equipment and Supplies).

• The government retains sole discretion to determine whether competition is possible.