Automated Nitric Oxide Therapy System: Connected iNO Delivery for NICU Patients
Development of an FDA-compliant automated inhaled Nitric Oxide (iNO) therapy system for NICUs treating newborns with persistent pulmonary hypertension. Features precise gas delivery, real-time monitoring, cloud connectivity for remote oversight, and comprehensive safety systems. Reduces iNO therapy costs by 60% while improving treatment outcomes.
The Challenge
Newborns with Persistent Pulmonary Hypertension of the Newborn (PPHN) require precise inhaled Nitric Oxide therapy, but existing systems are prohibitively expensive and lack remote monitoring capabilities. An affordable, connected solution was needed for NICUs in emerging markets.
Our Solution
We developed a fully automated iNO delivery system with precise gas mixing, real-time monitoring, cloud connectivity for remote specialist oversight, and comprehensive safety interlocks - achieving FDA clearance while reducing treatment costs by 60%.
System Architecture
Complete iNO therapy ecosystem from gas delivery to cloud monitoring.
Custom Hardware Design
| MCU | STM32F7 (Safety-critical rated) |
| Flow Control | Mass flow controllers (±1%) |
| NO Sensor | Electrochemical (0-100 ppm) |
| NO2 Sensor | Electrochemical (0-10 ppm) |
| Display | 7" Medical-grade LCD |
| Connectivity | WiFi + Ethernet + 4G backup |
| Power | Medical-grade PSU + 4hr UPS |
| Enclosure | IP54, IEC 60601-1 compliant |
Safety-Critical Firmware (IEC 62304 Class C)
- Dual-core architecture with safety processor
- Watchdog supervision with safe-state fallback
- Real-time NO/NO2 PID control loop (100 Hz)
- Alarm management with priority escalation
- Comprehensive event logging (1-year storage)
- Secure OTA updates with rollback capability
- Self-test routines on startup and continuously
- FDA 21 CFR Part 11 compliant audit trail
Implementation Timeline
Results & Impact
The automated iNO therapy system has been deployed to 500+ NICUs, dramatically improving access to this life-saving treatment while reducing costs by 60%. The connected platform enables remote expert oversight for NICUs lacking specialized staff.
Dosing Accuracy
Exceeds FDA requirements
Cost Reduction
vs traditional iNO therapy
NICUs Deployed
Across 8 countries
Uptime
Device reliability
Remote Consultations
Expert sessions conducted
Lives Treated
Newborns receiving therapy
“Before this system, we had to transfer PPHN babies to tertiary centers 200km away - many didn't survive the journey. Now we can treat them here with remote specialist support. It's genuinely saving lives in our community.”
Head of Neonatology
District Hospital NICU, India