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FDA clears Stereotaxis’ Synchrony system

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Stereotaxis (NYSE: STXS) has received FDA 510(k) clearance for its Synchrony system, designed to digitize and modernize the interventional cath lab.

According to Stereotaxis, Synchrony is made available with SynX, a cloud-based HIPAA and GDPR-compliant app that allows for secure remote connectivity, collaboration, recording, and monitoring of the cath lab.

In a statement, Dr. Mauricio Arruda, professor of medicine at Case Western Reserve University School of Medicine and director of electrophysiology at University Hospitals Harrington Heart & Vascular Institute, commented, “We have long recognized that seamless remote connectivity and collaboration for our EP labs could be very beneficial. We are particularly interested in being early pioneers of Synchrony and SynX, and look forward to demonstrating that intraoperative collaboration enhances our ability to provide the best patient care and train the next generation of physicians.”

David Fischel, chairman and CEO of Stereotaxis, remarked, “Synchrony and SynX are central to our digital surgery efforts to modernize the interventional lab with enhanced workflow, remote connectivity, and smart AI capabilities. The technology improves the robotic cockpit, and will be critical in supporting robotic efforts for remote long-distance procedures and automated catheter navigation. The opportunity is much broader than robotic labs as we believe all cath labs stand to benefit from improved workflow, connectivity, and collaboration.”

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