{"id":"1570fb0f-67fb-4ebe-b081-e3efd981a58d","slug":"fda-510k-momentis-anovo-multiport-2026-07","kind":"regulatory_action","headline":"FDA grants 510(k) clearance to Momentis Surgical Anovo system for multiport surgery, first platform supporting all three surgical access approaches","summary":"The U.S. FDA granted 510(k) clearance for the multiport configuration of Momentis Surgical's Anovo Surgical System on July 23, 2026. The clearance makes Anovo the first robotic surgical platform capable of supporting natural orifice, single-port, and multiport procedures on a single system, expanding the platform beyond its previously cleared indications.","occurredAt":"2026-07-23T12:00:00.000Z","reviewStatus":"reviewed","modelId":null,"deploymentId":null,"companyId":"febb0fc1-a961-4d6c-88b7-3d870c63bc4d","aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"moderate","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":"2026-07-25T14:08:09.385Z","updatedAt":"2026-08-09T05:24:01.599Z","model":null,"deployment":null,"company":{"id":"febb0fc1-a961-4d6c-88b7-3d870c63bc4d","name":"Momentis Surgical","slug":"momentis-surgical","description":"Israeli surgical robotics company developing the ANOVO™ Robotic Surgical System, a miniaturized platform for transvaginal benign gynecological procedures and general surgery. ANOVO features 2-armed, 360-degree articulating robotic instruments designed to mimic human arms with haptic feedback. The second-generation ANOVO received FDA 510(k) clearance, introducing haptic feedback and dual-mode articulation. Deployed at hospitals including HCA Florida Northwest Hospital, Medical City Plano (Texas), and Lee Health (Florida). Competes with [Intuitive Surgical](/companies/intuitive-surgical) in the robotic surgery market.","status":null,"founded":2012,"hq":"Yokne'am Illit, Israel","hqLat":null,"hqLng":null,"hqGeocodedAt":"2026-08-05T14:39:37.987Z","hqAddress":null,"hqPrecision":null,"website":"momentissurgical.com","fundingTotal":null,"type":null,"reviewStatus":"reviewed","lifecycleState":"active","supersededByCompanyId":null,"sources":[{"url":"https://southfloridahospitalnews.com","label":"South Florida Hospital News"}],"keyFacts":[{"label":"CEO","value":"Dvir Cohen (Co-Founder, since October 2013)"},{"label":"Product","value":"ANOVO™ Robotic Surgical System"},{"label":"FDA 510(k)","value":"First gen: gynecological procedures; Second gen: haptic feedback + dual-mode articulation + general surgery"},{"label":"Total funding","value":"$128-133M (7 rounds)"},{"label":"Financial stage","value":"Growth — initial revenues, Series E stage"},{"label":"Employees","value":"~65 (49 in Israel)"},{"label":"Deployments","value":"HCA Florida Northwest Hospital, Medical City Plano, Lee Health"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"factoryLocations":null,"manufacturingCapacity":null,"orgType":null,"burnSignal":null,"litigationEvents":null,"insurancePostureDisclosed":null,"unitEconomicsDisclosed":null,"tickerSymbol":null,"stockExchange":null,"secCik":null,"revenueUsd":null,"revenueBasis":null,"revenueAsOf":null,"employeeCount":null,"employeeCountBasis":null,"employeeCountAsOf":null,"marketCapUsd":null,"marketCapAsOf":null,"marketCapSource":null,"createdAt":"2026-07-18T12:44:05.124Z","updatedAt":"2026-08-05T14:46:39.215Z"},"derived":{"status":"active"},"sources":[{"id":"b32d39fd-e14d-4acb-8afa-f64ae17233ab","incidentId":"1570fb0f-67fb-4ebe-b081-e3efd981a58d","url":"https://www.prnewswire.com/news-releases/fda-clears-momentis-surgicals-anovo-system-for-multiport-surgery-making-it-the-first-robotic-platform-to-support-three-surgical-approaches-302833131.html","label":"PR Newswire","publishedAt":"2026-07-23T00:00:00.000Z","notes":null,"title":null,"sourceName":"PR Newswire","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-25T14:08:09.385Z","updatedAt":"2026-07-25T14:08:09.385Z"},{"id":"bc96bf7f-8be3-4aa0-9832-04cd6f59c16c","incidentId":"1570fb0f-67fb-4ebe-b081-e3efd981a58d","url":"https://www.massdevice.com/fda-clears-momentis-multi-port-robot/","label":"MassDevice","publishedAt":"2026-07-23T00:00:00.000Z","notes":null,"title":null,"sourceName":"MassDevice","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-25T14:08:09.385Z","updatedAt":"2026-07-25T14:08:09.385Z"}],"responses":[],"statusEvents":[{"id":"44006037-30cd-472b-899a-917d1b1d9c2c","incidentId":"1570fb0f-67fb-4ebe-b081-e3efd981a58d","status":"active","reason":null,"source":"agent:recon","effectiveAt":"2026-07-25T14:08:10.721Z","createdAt":"2026-07-25T14:08:10.721Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/fda-510k-momentis-anovo-multiport-2026-07","url":"https://registry.deploy.report/incidents/fda-510k-momentis-anovo-multiport-2026-07","headline":"FDA grants 510(k) clearance to Momentis Surgical Anovo system for multiport surgery, first platform supporting all three surgical access approaches","description":"The U.S. FDA granted 510(k) clearance for the multiport configuration of Momentis Surgical's Anovo Surgical System on July 23, 2026. The clearance makes Anovo the first robotic surgical platform capable of supporting natural orifice, single-port, and multiport procedures on a single system, expanding the platform beyond its previously cleared indications.","identifier":"1570fb0f-67fb-4ebe-b081-e3efd981a58d","datePublished":"2026-07-23T12:00:00.000Z","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":"verified","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":2,"primary_source_types":[]}}}