- A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.
Stereotaxis received FDA clearance for commercial launch and submitted applications regarding its procedures in the U.S. market.
2 reports, 2 independent
Updated Sep 3
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What happened
Stereotaxis received FDA clearance for commercial launch and submitted applications regarding its procedures in the U.S. market.
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.- Stereotaxis received FDA clearance for a diagnostic catheter and utilizes Genesis robotic navigation systems.Sub-event
- Stereotaxis CEO David Fischel is scheduled to present at conferences in New York City.Sub-event
Stereotaxis achieved FDA clearance for commercial procedures in the U.S.1 source
Keep exploring
Part of
A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.Also in this story
- A partnership with BARDA has accelerated the development of SCY-247 for the company.
- A company plans to submit regulatory applications to the FDA, EMA, and Australian TGA.
- Approval leads to procurement process initiation.
- UroGen Pharma Ltd., headquartered in Princeton, is seeking FDA approval for its products for the U.S. market.
The entities involved
-
Stereotaxis
American medical robotics company
- FDA
Related events
- FDA approval preceded a device showcase event held in Las Vegas on October 13, 2026.
- Both the FDA and the European Medicines Agency govern drug approval processes.
- FDA approval is the goal for product candidates from Daré Bioscience, Inc.
- Eli Lilly and Company plans to submit a drug candidate to the FDA for review and approval.
- Generic medicine services are seeking approval for launch from the FDA.
Coverage
Newest first; wire copies grouped- ZacksSTXS Launches First U.S. Robotic HD Mapping With MAGiC Sweep Stereotaxis STXS, a global leader in surgical robotics for minimally invasive endovascular intervention, recently announced the successful
- GlobeNewswireFirst US Commercial Robotic HD Mapping Procedures Successfully Completed with MAGiC Sweep Catheter ST. LOUIS, Sept. 02, 2025 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader