The FDA clearance removes a key regulatory hurdle, enabling immediate commercial rollout. With strong physician endorsements and a clear path to $3M+ in non-robotic revenue, Synchrony could become a near-term revenue driver. Traders should monitor Q2 and Q3 revenue recognition and adoption rates at key centers like Allina Health and University Hospitals.
Price Chart
Executive Summary
Stereotaxis announced FDA 510(k) clearance for its Synchrony™ system, a digital platform designed to modernize the interventional cath lab with enhanced visualization, workflow, and remote collaboration via its SynX™ cloud app. The company reiterated guidance for over $3 million in revenue this year from Synchrony placements independent of robotic systems.
Key Financial Metrics
Key Facts
- Stereotaxis received FDA 510(k) clearance for the Synchrony™ system, a 55” 4K ultra-high-definition display platform for cath labs.
- Synchrony integrates and streamlines disparate lab systems with custom layouts, ultra-low latency video, and an intuitive interface.
- SynX™, a HIPAA/GDPR-compliant cloud app, enables secure remote collaboration, recording, and monitoring.
- The company reiterated guidance for over $3 million in revenue this year from Synchrony systems placed outside robotic sales.
- Multiple leading electrophysiologists expressed strong interest in adopting the technology, citing workflow and training benefits.
Financial Impact
Over $3 million in incremental revenue expected in 2026 from Synchrony systems alone.
Risk Factors
- Execution risk in scaling production and deployment of Synchrony systems.
- Forward-looking statements are subject to risks including customer adoption, global economic conditions, and healthcare policy changes.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3268405 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Sep 3, 2026 7w ago | Press Release | $1.39 $1.18 | ▼ −15.11% | ▼ −13.92% | $0.9900 (−28.78%) |
Aug 14, 2026 10w ago | EFFECT | $1.38 $1.33 | ▲ +3.62% | ▲ +1.63% | $0.9900 (+28.26%) |
Aug 14, 2026 10w ago | EFFECT | $1.38 $1.33 | ▲ +3.62% | ▲ +1.63% | $0.9900 (+28.26%) |
Aug 11, 2026 10w ago | Press Release | $1.40 $1.30 | ▼ −7.14% | ▼ −5.25% | $0.9900 (−29.29%) |
Jul 15, 2026 14w ago | S-3 | $1.65 $1.38 | ▲ +16.36% | ▲ +19.98% | $0.9900 (+40.00%) |
Jul 15, 2026 14w ago | S-3 | $1.65 $1.38 | ▼ −16.36% | ▼ −19.98% | $0.9900 (−40.00%) |
Jul 9, 2026 15w ago | 8-K | $1.74 $1.36 | ▼ −21.84% | ▼ −24.08% | $0.9900 (−43.10%) |
May 12, 2026 23w ago | 8-K | $1.85 $1.82 | ▲ +1.62% | ▲ +1.01% | $0.9900 (+46.49%) |
May 12, 2026 23w ago | Press Release | $1.85 $1.82 | ▼ −1.62% | ▼ −1.01% | $0.9900 (−46.49%) |
Apr 21, 2026 26w ago | Press Release | $1.92 $1.78 | ▼ −7.29% | ▼ −12.21% | $0.9900 (−48.44%) |
US Market Status
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