CardioCore™ is a deterministic execution kernel for life-critical medical device software, designed to support reproducible, replayable execution for implantable cardiac devices under defined conditions. It supports forensic incident analysis, regulatory evidence generation, and post-incident review for manufacturers operating under IEC 62304 Class C requirements.

The problem

Implantable cardiac devices fail in the real world—inside patients, under conditions that cannot be recreated in the lab. When this happens, manufacturers are expected to explain exactly what the software did and why. Today, that is not technically possible.

Unreproducible failures

Execution depends on interrupts, timing jitter, and scheduler decisions that cannot be reconstructed after the fact.

Significant patient safety impact in device-related incidents

Escalating recall costs

Software-driven recalls dominate remediation spend because behaviour cannot be proven definitively.

Hundreds of millions in reported recall costs

Unbounded liability

Without deterministic evidence, post-incident analysis becomes opinion rather than proof.

Substantial recurring industry costs

The solution

CardioCore replaces non-deterministic RTOS behaviour with a deterministic execution substrate designed specifically for implantable cardiac devices. Execution is designed to be reproducible, auditable, and verifiable under defined system conditions.

Core design principle

Given an initial system state and a complete event log, CardioCore is designed to produce reproducible, bit-identical replay of execution traces across supported hardware configurations.

This is achieved through logical-time scheduling, pure-function task execution, and a cryptographically chained audit log.

Determinism by construction

Logical time only

Execution advances by deterministic ticks rather than wall-clock time, interrupts, or hardware jitter.

Pure execution model

Tasks execute as side-effect-free functions with explicit state, supporting replayability.

Cryptographic audit trail

Every state transition is hash-chained, producing tamper-evident, forensic-grade evidence.

Scope note: CardioCore does not replace device-specific control logic or clinical decision algorithms. It is a deterministic execution substrate intended to replace or underlay existing safety kernels.

Validation

CardioCore has been validated as a deterministic execution substrate at proof-of-concept level through comprehensive automated testing.

80 Automated tests passing

✓ Byte-identical replay verified

3 Hardware platforms tested

±2µs Simulated pacing precision

Validation includes cross-platform replay verification, deterministic reconstruction of simulated cardiac signals, and architectural design alignment with IEC 62304 Class C requirements. Formal medical device certification would be completed by the acquiring organization.

Acquisition relevance

CardioCore is designed to be acquired, licensed, or embedded as a foundational platform capability by medical device manufacturers.

Implantable Cardiac Device Manufacturers

IEC 62304 Class C

Deterministic execution substrates can support improved post-incident analysis, regulatory confidence, and long-term liability management.

Cardiac Rhythm Management Leaders

High-volume device portfolios

Verifiable execution architecture can address regulatory scrutiny and support security and safety compliance requirements.

Emerging Medical Device Companies

Competitive differentiation

Deterministic architecture can support differentiation and potentially streamline certification pathways for new entrants.

Development Status: CardioCore is a validated proof-of-concept with working code and comprehensive test suite. Production readiness, medical device certification, and clinical validation would be completed by the acquiring organization.

Strategic medical IP

Detailed technical documentation, test artifacts, architectural specifications, and patent materials available under NDA.

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