A connected device platform designed for the future of regenerative care.
4th State Medical is developing a next-generation medical device concept intended to integrate connected operation, consumable traceability, and clinical workflow support.
What we are engineering now.
The device program is focused on establishing a robust technical and regulatory foundation before any commercial release. The following priorities guide current engineering, quality, and regulatory work.
- 01Clinical need & concept definition
- 02Industrial & medical-grade design
- 03Quality-system planning
- 04Risk management & design controls
- 05Safety & performance testing
- 06Consumable compatibility analysis
- 07Human-factors evaluation
- 08Cybersecurity & data protection
- 09Regulatory classification & pathway
- 10Preclinical & clinical evidence planning
What the platform is designed to enable in the future.
Future device architecture designed to record session parameters, verify operating state, and support consistent use across clinical settings.
Intended capability to verify consumable identity and compatibility before use, helping reduce mismatched or expired components.
Planned data capture for lot numbers, expiration dates, and supply-chain traceability linked to each device-use session.
Future device-use session records designed to support quality review, training feedback, and structured outcomes data collection.
Planned automated notifications for consumable levels, expiration proximity, and replenishment needs.
Future secure synchronization with a cloud platform for device management, dashboard access, and data governance.
Designed to align with existing clinical processes, EMR interoperability objectives, and multi-user care-team environments.
Intended support for structured data collection to enable real-world evidence, quality reporting, and study participation.
Architecture planned to accommodate future analytics, protocol benchmarking, and decision-support tools developed under appropriate regulatory frameworks.
4th State Fusion
A dual-handpiece concept console designed to unify device operation, consumable authentication, and session data capture within a single connected workstation. Final industrial design, materials, user interface, and feature set are subject to change through engineering iteration, testing, and regulatory review.
Placeholder notice: Final device renderings, engineering specifications, and connected-system diagrams will replace this concept as development milestones are completed.
How device, consumable, and data may work together.
- Connected operation
- Usage logging
- Cloud sync
- Authentication
- Lot tracking
- Expiration alerts
- Clinical dashboard
- Outcomes data
- Future AI analytics
A disciplined route from concept to future authorization.
The device program is expected to follow a structured quality-system and regulatory pathway. The specific submission type, testing scope, and permitted claims for any product will be determined only after regulatory analysis based on the final intended use and technological characteristics.