SYNCRA is a robotic catheter navigation system delivering precision cardiac intervention — radiation-free, AI-guided, and built for the cardiac surgeons of tomorrow.
Cardiac structural disease is one of the leading causes of death worldwide. While minimally invasive surgery has advanced patient outcomes, critical limitations still put patients and surgeons at risk.
The need: a safer, more accurate, and simpler alternative minimally invasive technology for cardiac surgery.
The SYNCRA Robotic Catheter Navigation System is a breakthrough platform designed to assist trained physicians in the controlled manipulation and positioning of compatible catheters during interventional cardiac procedures.
Indicated for use in hospital catheterization laboratories and operating rooms, SYNCRA provides mechanical support and precise control of catheter movement — all under continuous physician supervision. The system does not diagnose disease, recommend therapy, or deliver energy.
Robotic catheter navigation system for trained physicians — diagnostic and interventional endovascular procedures
Physician-controlled at all times — mechanical support with precise, continuous operator oversight
FDA Class II · 510(k) · Breakthrough Device Designation
A robotic arm delivers sub-millimeter catheter positioning, eliminating hand tremor and enabling repeatable accuracy across complex cardiac anatomies.
Powered by transesophageal echocardiography (TEE) and magnetic field tracking — zero fluoroscopic X-ray exposure for patients and the entire surgical team.
Real-time AI image interpretation, augmented reality overlays, and patient-specific procedural planning dramatically reduce cognitive burden on surgeons.
SYNCRA anchors a fully integrated procedural ecosystem — from multimodality pre-operative planning to real-time augmented reality guidance and post-procedure analytics.
A robotic arm integrates seamlessly with ultrasound guidance at the bedside. The surgical team maintains a sterile field with no radiation exposure — making complex procedures accessible to higher-risk and older patients.
A haptic console provides intuitive force feedback combined with augmented reality visualization — giving surgeons a real-time 3D view of cardiac anatomy and live catheter position, dramatically simplifying complex navigation.
CT, ultrasound, and fluoroscopy data fused into a single procedural view for pre-operative planning and intraoperative guidance
Tendon-driven flexible catheter controlled by a robotic arm with magnetic field tracking for unprecedented maneuverability inside the heart
Surgeon-facing AR display overlays procedural anatomy in real time, closing the perception gap of traditional cathlab navigation
SYNCRA creates measurable value across the entire cardiac care ecosystem — from the patient on the table to the health system managing throughput and clinical outcomes.
Working prototypes spanning all three pillars of the SYNCRA system have been built and validated — robotic navigation, radiation-free ultrasound imaging, and augmented reality intelligence.
A working robotic arm with TEE probe integration validated in the lab, demonstrating full catheter navigation without fluoroscopy.
AR headset-based interface prototyped and tested, enabling real-time 3D visualization of catheter position within cardiac anatomy.
IP portfolio covering robotic driver system design, catheter design & control, delivery accessories, and full system integration architecture.
Acute animal study completed, providing early safety and system performance data supporting regulatory pathway planning.
SYNCRA follows a well-established FDA Class II regulatory pathway with strong predicate support, targeting market clearance by 2030.
Established predicates: Corpath GRX and Genesis RMN robotic catheter systems provide a clear 510(k) predicate pathway.
SYNCRA targets FDA Breakthrough Device Designation — a pathway for technologies offering significant clinical advantages for life-threatening conditions with no adequate existing alternatives.
Procedure category qualifies for 100% Medicare and Medicaid reimbursement, enabling broad patient access from day one of commercialization.
Quality system implementation, design controls, electrical safety & EMC verification
FDA feedback session, study design agreement, and Breakthrough designation filing
Preclinical in-vivo testing to fully characterize the safety profile
IDE study, FIH trial with short follow-up through strategic hospital partnership
Prepare and submit FDA 510(k) application — targeting market clearance and initial commercialization
Structural heart disease affects tens of millions globally, concentrated in high-volume cardiac centers with the infrastructure and clinical volume to adopt next-generation robotics.
SYNCRA is positioned for a B2B licensing strategy — enabling rapid commercial scale through partnerships with device manufacturers and health systems, without requiring a large direct hospital sales force at launch.
Whether you're a clinical partner, strategic investor, or healthcare innovator — we'd love to connect and explore how SYNCRA can transform cardiac care.