Developing a hardware-enforced control architecture that physically conditions therapeutic energy on real-time verified positional confidence — transforming ablation precision for moving anatomical targets.
"No current ablation system verifies probe position at the moment energy is delivered. The clinician makes the call. The system does not check."
Targets move. During percutaneous ablation, lung nodules shift 10–30mm with every breath. The ablation margin extends only 2–5mm beyond the probe tip.
Sensors go blind. Active RF energy degrades electromagnetic tracking. Ultrasound is obscured by acoustic artefact. Worst visibility occurs at the moment of delivery.
Humans can't react fast enough. Manual respiratory gating relies on clinician reaction time of 150–300ms — longer than the safe delivery window.
Tumors and anatomical targets move with every breath. Conventional ablation systems deliver energy continuously — with no verification that the probe is on target at the moment of firing.
SyncAblate introduces a hardware-enforced safety gate that allows therapeutic energy delivery only when real-time positional confidence is verified — enforced in silicon, not software.
Precise ablation of moving targets with reduced collateral damage — enabling procedures that are currently too high-risk to perform, and improving outcomes in the procedures that are.
SyncAblate is a hardware control module designed to integrate with existing imaging and therapeutic energy systems. It evaluates real-time positional confidence and enforces energy gating — allowing the existing ablation generator to fire only when the target is verified to be within the defined safety margin.
SyncAblate does not replace existing imaging or ablation devices. It connects between them — enabling motion-synchronised, position-verified energy delivery on platforms already in clinical use.
A predictive motion model estimates target position 150–300ms ahead, compensating for imaging and system latency. Energy arrives where the tumour will be — not where it was observed.
An FPGA-controlled fail-safe relay sits in series with the generator activation pathway. Energy physically cannot be delivered unless positional confidence exceeds a defined threshold — enforced in hardware, independent of software.
A hardware-governed duty cycle periodically interrupts energy delivery to create electromagnetically quiet windows. Ground-truth position is reacquired at each window, preventing accumulated prediction error over multi-minute procedures.
The existing ablation generator fires — with no hardware modification. The system integrates as a modular interceptor between the clinician's footswitch and the generator activation port.
Answers to the questions most commonly raised by interventional radiologists, biomedical engineers, and potential development partners.
The system does not rely on a simple periodic waveform model. The Layer 01 predictive engine uses a sliding-window algorithm that continuously adapts to irregular breathing, sudden patient movement, and breath-hold deviations. The safety envelope is recalculated every few milliseconds. If the pattern becomes too irregular to predict with sufficient confidence, positional confidence drops below the threshold and the hardware gate inhibits delivery automatically — the same fail-safe behaviour as a sensor disconnection.
At an 85% energy-on duty cycle, the impact on total thermal dose is clinically negligible. The reacquisition windows are measured in tens of milliseconds — long enough for ground-truth sensor reacquisition, but too short for significant tissue cooling to occur. Published data on existing pulsed ablation protocols supports this. The net effect is a marginally extended total procedure time with no meaningful change in ablation zone geometry.
The hardware relay opens in under 2ms of the FPGA issuing an inhibit command — this is the deterministic hardware path. Total system latency from positional confidence dropping below threshold to generator output ceasing is governed by the relay opening time plus the generator's own power-down ramp, which is typically 20–30ms for standard RF generators. The system is designed around a worst-case budget of 87ms for the full reacquisition cycle, with a 13ms margin against the 100ms quiet window.
SyncAblate is a modular interceptor. It connects to the generator's standard footswitch activation port — the same port the clinician's footpedal normally connects to. When the clinician presses the pedal, the signal reaches the FPGA first. If the target is within the positional safety margin, the relay closes and the signal passes to the generator in under 2ms. If not, the relay stays open and no signal reaches the generator. The generator has no awareness that the interceptor is present — it simply sees a footswitch input.
No. SyncAblate ingests standard sensor data streams — electromagnetic tracking, ultrasound, and available imaging — and processes them externally on its own hardware. It operates as a fully independent safety layer. Your existing regulated generator hardware and software remain unmodified and within their original regulatory clearance. This is a deliberate architectural choice: modifying a cleared medical device would require re-submission. SyncAblate avoids that pathway entirely.
The architecture is designed to be sensor-agnostic at the hardware level. The primary validated configuration uses an NDI Aurora-class electromagnetic tracker as the ground-truth reacquisition sensor and a standard B-mode ultrasound as the primary tracking modality during active delivery. The sensor arbitration logic in the FPGA is configurable, allowing integration with alternative EM and ultrasound platforms. CT fluoroscopy, cone-beam CT, and optical tracking embodiments are covered in the patent portfolio.
The hardware safety gate is fail-safe by design. If positional confidence drops below the required threshold for any reason — sensor disconnection, excessive interference, or loss of tracking — the FPGA relay opens immediately, halting energy delivery in under 2ms. Energy cannot resume until tracking confidence is restored and verified above the threshold. The clinician is never locked out: they retain the ability to abort the procedure at any point by releasing the footpedal, which overrides the system entirely.
The hardware-enforced inhibition logic is modality-agnostic. The relay intercepts the activation pathway regardless of the energy type the generator produces downstream. Compatibility covers radiofrequency ablation (RFA), microwave ablation (MWA), cryoablation, laser ablation, high-intensity focused ultrasound (HIFU), and irreversible electroporation (IRE). All six modalities are explicitly claimed in the patent portfolio.
Because SyncAblate does not modify any cleared medical device and functions as an add-on safety accessory, the anticipated pathway in Australia is TGA Class IIb under the AIMD framework, with a parallel CE Mark submission under the EU MDR for international markets. The modular interceptor architecture was specifically designed to maintain the regulatory status of existing generators, which substantially simplifies the submission scope. This will be refined in consultation with a regulatory affairs specialist prior to any clinical trial submission.
Additional technical documentation is available under mutual NDA. Contact us to request access →
Three provisional patent applications have been filed with IP Australia, covering distinct layers of the SyncAblate control architecture. A PCT international application is planned for early 2027.
Covers the AI-driven predictive targeting system and real-time motion synchronisation architecture for moving anatomical targets during continuous therapeutic energy delivery.
IP Australia FiledCovers the FPGA-controlled hardware safety gate architecture, fail-safe relay design, and modular interceptor embodiment that conditions energy delivery on verified positional confidence.
IP Australia FiledCovers the hardware-governed pulsed duty cycle system that creates deterministic sensing windows for ground-truth positional reacquisition throughout multi-minute therapeutic procedures.
IP Australia FiledA disciplined progression from computational modelling to pre-clinical validation, designed to satisfy regulatory requirements and de-risk early clinical adoption.
Modelling of motion-synchronised energy gating across respiratory and cardiac motion profiles. Validation of positional confidence thresholds and inhibition timing.
Hardware validation using motion phantoms. Measurement of relay response times, gating accuracy, and system latency under simulated clinical conditions.
Imaging-guided integration testing with existing ablation platforms. Verification of signal interfaces, safety inhibition logic, and clinical workflow compatibility.
Pre-clinical testing in relevant tissue models. Regulatory submission preparation targeting TGA Class IIb (Australia) and CE Mark under EU MDR.
SyncAblate is designed to sit between existing clinical systems — not replace them. This positions the technology as a high-value integration layer for established imaging and therapeutic energy platforms.
CT fluoroscopy · Cone-beam CT · Ultrasound · Electromagnetic tracking · Optical tracking · MR tracking
Positional confidence evaluation · Hardware safety gating · Motion synchronisation · Fail-safe relay control
Radiofrequency ablation · Microwave ablation · Cryoablation · Laser ablation · HIFU · Irreversible electroporation
SyncAblate is actively seeking clinical feedback from interventional radiologists and oncologists, research collaboration with academic engineering groups, and discussions with medical device companies interested in licensing or development partnerships.
Full technical architecture and engineering documentation are available for discussion under a mutual non-disclosure agreement.