Stereotaxis Shares Rise on FDA Clearance for Synchrony
By Elias Schisgall
Shares of Stereotaxis rose after the company said its Synchrony system had received clearance from the Food and Drug Administration.
Shares were up 5.4% to $1.97 in Monday morning trading. The stock is down 14% year-to-date.
The medical technology company said Monday that the FDA issued 501(k) clearance for Synchrony, a video system used in interventional cath labs. The FDA's 501(k) clearance indicates that a premarket medical device is substantially equivalent to a legally marketed device.
The Synchrony system uses the company's cloud-based SynX app and provides high-definition video streams and consolidated controls of laboratory systems, Stereotaxis said.
"Synchrony and SynX are central to our digital surgery efforts to modernize the interventional lab with enhanced workflow, remote connectivity, and smart AI capabilities," Stereotaxis Chief Executive David Fischel said. "The technology improves the robotic cockpit, and will be critical in supporting robotic efforts for remote long-distance procedures and automated catheter navigation."
The company reiterated its guidance for more than $3 million in revenue this year from Synchrony systems placed independent of other robotic systems.
Write to Elias Schisgall at elias.schisgall@wsj.com
(END) Dow Jones Newswires
April 06, 2026 10:47 ET (14:47 GMT)
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