{"id":"ab46d800-4da3-4ebc-b839-f5ae6cc0fb77","slug":"stereotaxis-synchrony-fda-510k-2026-04","kind":"regulatory_action","headline":"FDA grants 510(k) clearance for Stereotaxis Synchrony system for digital cath lab","summary":"Stereotaxis received FDA 510(k) clearance for the Synchrony system, designed to digitize and modernize the interventional cath lab with a 55-inch 4K display consolidating lab system control. Synchrony includes SynX, a cloud-based HIPAA and GDPR-compliant app for remote connectivity and collaboration. The clearance was announced April 6, 2026.","occurredAt":"2026-04-06T00:00:00.000Z","reviewStatus":"unreviewed","modelId":null,"deploymentId":null,"companyId":"e401d2c7-b035-4dea-9b60-ae0d2bb9b99b","aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"minor","rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":null,"affectedUnitsBasis":null,"remediationStatus":null,"regulatoryAction":"other","regulatoryBody":"FDA","propertyDamageEstimateUsd":null,"damageEstimateBasis":null,"bodilyInjurySeverity":null,"fatalityCount":null,"lossCostClass":null,"sourceQualityTier":null,"oshaRecordable":null,"oshaCaseNumber":null,"rootCauseDisclosed":null,"publicDisclosureDate":null,"insuranceClaimPublic":null,"formFactor":null,"latitude":null,"longitude":null,"autonomyClass":null,"legalOutcomeClass":"unknown","createdAt":"2026-07-22T15:45:41.244Z","updatedAt":"2026-07-22T15:45:41.244Z","model":null,"deployment":null,"company":{"id":"e401d2c7-b035-4dea-9b60-ae0d2bb9b99b","name":"Stereotaxis","slug":"stereotaxis","description":"Stereotaxis is an American medical device company based in St. Louis, Missouri, developing magnetic navigation technology for robotic cardiology procedures. Its [Genesis RMN](/models/genesis-rmn) system uses robotically controlled magnets to guide flexible catheters with magnetic tips during cardiac ablation procedures, and received FDA clearance and NMPA approval in China.","status":"public (NYSE American: STXS)","founded":1990,"hq":"St. Louis, MO, USA","fundingTotal":null,"type":"both","reviewStatus":"reviewed","lifecycleState":"active","supersededByCompanyId":null,"sources":[{"url":"https://www.globenewswire.com/news-release/2025/11/10/stereotaxis-genesisx-fda-clearance","title":"Stereotaxis GenesisX RMN system receives US FDA 510(k) clearance (Nov 10 2025)","sourceName":"Stereotaxis (GlobeNewswire)"},{"url":"https://www.globenewswire.com/news-release/2026/01/06/stereotaxis-magic-catheter-fda","title":"Stereotaxis MAGiC magnetic ablation catheter receives FDA approval (Jan 6 2026)","sourceName":"Stereotaxis (GlobeNewswire)"},{"url":"https://www.globenewswire.com/news-release/2026/05/12/stereotaxis-q1-2026-results","title":"Stereotaxis Q1 2026 results (revenue $6.3M; Robocath acquisition agreement)","sourceName":"Stereotaxis (GlobeNewswire)"}],"keyFacts":[{"label":"Product","value":"Genesis RMN / GenesisX Robotic Magnetic Navigation"},{"label":"Gating events","value":"GenesisX CE Aug 2024 + FDA 510(k) Nov 10 2025; MAGiC FDA Jan 6 2026."},{"label":"Stock listing","value":"NYSE American: STXS"},{"label":"Installed base","value":">100 RMN systems installed"},{"label":"CEO","value":"David Fischel"},{"label":"Regulatory","value":"FDA cleared, NMPA cleared (China)"},{"label":"Listed on","value":"NYSE: STXS"}],"aliases":["STXS","Genesis RMN","GenesisX"],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"factoryLocations":null,"manufacturingCapacity":null,"orgType":null,"burnSignal":null,"litigationEvents":null,"insurancePostureDisclosed":null,"unitEconomicsDisclosed":null,"tickerSymbol":"STXS","stockExchange":"NYSE AMERICAN","secCik":"0001289340","revenueUsd":"32377000","revenueBasis":"disclosed","revenueAsOf":"2025-12-31T12:00:00.000Z","employeeCount":null,"employeeCountBasis":null,"employeeCountAsOf":null,"marketCapUsd":null,"marketCapAsOf":null,"marketCapSource":null,"createdAt":"2026-06-03T20:13:00.997Z","updatedAt":"2026-07-23T03:16:50.903Z"},"derived":{"status":"active"},"sources":[{"id":"05b972a7-41ff-420f-a3ef-74bf9260479e","incidentId":"ab46d800-4da3-4ebc-b839-f5ae6cc0fb77","url":"https://ir.stereotaxis.com/news-releases/news-release-details/stereotaxis-announces-fda-clearance-and-launch-synchrony-system","label":"Stereotaxis IR","publishedAt":null,"notes":null,"title":null,"sourceName":"Stereotaxis IR","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-22T15:45:41.244Z","updatedAt":"2026-07-22T15:45:41.244Z"}],"responses":[],"statusEvents":[{"id":"3485e48b-d542-4bfa-b6fd-0c3afae6b816","incidentId":"ab46d800-4da3-4ebc-b839-f5ae6cc0fb77","status":"active","reason":null,"source":"agent:recon","effectiveAt":"2026-07-22T15:45:42.408Z","createdAt":"2026-07-22T15:45:42.408Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/stereotaxis-synchrony-fda-510k-2026-04","url":"https://registry.deploy.report/incidents/stereotaxis-synchrony-fda-510k-2026-04","headline":"FDA grants 510(k) clearance for Stereotaxis Synchrony system for digital cath lab","description":"Stereotaxis received FDA 510(k) clearance for the Synchrony system, designed to digitize and modernize the interventional cath lab with a 55-inch 4K display consolidating lab system control. Synchrony includes SynX, a cloud-based HIPAA and GDPR-compliant app for remote connectivity and collaboration. The clearance was announced April 6, 2026.","identifier":"ab46d800-4da3-4ebc-b839-f5ae6cc0fb77","datePublished":"2026-04-06T00:00:00.000Z","articleSection":"regulatory action","publisher":{"@id":"https://deploy.report/#organization"},"author":{"@id":"https://deploy.report/#organization"}},"framework_metadata":{"framework_schema_version":"0.1.0","verification_status":"unreviewed","maturity_stage":null,"lifecycle_state":null,"architectural_position":{"cohort":null,"sub_cohorts":[]},"within_cohort_verified_vs_claimed_pair":null,"cap_flags":[],"verification_depth":{"sources_count":1,"primary_source_types":["primary-company-ir"]}}}