Stereotaxis, Inc. announced that its Synchrony system has received U.S. Food and Drug Administration 510(k) clearance. The 55‑inch 4K ultra‑high‑definition display is designed to digitize and modernize interventional cardiac catheterization laboratories by integrating video streams from all lab equipment into a single, low‑latency interface. The system is paired with SynX, a cloud‑based collaboration platform that enables remote connectivity for electrophysiology and other endovascular procedures.
The clearance unlocks commercial sales of Synchrony and SynX, a key milestone in Stereotaxis’ shift from capital equipment to a high‑margin recurring revenue model. Management has projected that the two products will generate more than $3 million in revenue this year, independent of the company’s robotic systems. This figure represents a significant portion of the company’s planned double‑digit revenue growth for 2026 and underscores the strategic importance of the digital surgery platform.
"Synchrony and SynX are central to our digital surgery efforts to modernize the interventional lab with enhanced workflow, remote connectivity, and smart AI capabilities," said CEO David Fischel. He added that the technology improves the robotic cockpit and will be critical for remote long‑distance procedures and automated catheter navigation, noting that the opportunity extends beyond robotic labs to all cath labs.
Stereotaxis’ broader financial outlook remains supportive of the new platform. The company guided for annual revenue exceeding $40 million in 2026, following a 20% growth in 2025. In Q4 2025 the company reported an adjusted operating loss of $2.6 million and a net loss of $2.5 million, but ended the year with $13.4 million in cash and no debt, providing a solid balance sheet for continued investment in the platform.
The announcement was positively received by investors, reflecting confidence in the company’s digital strategy and the potential for the Synchrony system to expand beyond its existing robotic platform. The FDA clearance is expected to accelerate the company’s transition to a recurring revenue model and broaden its market reach across all cath labs.
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