{"id":"25f63aab-17ed-453d-893b-d15a6142d0bc","slug":"regulatory-action-2026-03-30-butterfly-network","kind":"regulatory_action","headline":"Butterfly Network receives FDA clearance for AI ultrasound fetal biometric tool","summary":"FDA records show 510(k) clearance for Butterfly Network's Gestational Age Tool on March 27, 2026. The tool uses deep learning with Butterfly ultrasound systems to estimate gestational age ([FDA K252148](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252148.pdf)).","occurredAt":"2026-03-30T12:00:00.000Z","reviewStatus":"reviewed","modelId":"b2d13502-17cd-4a08-a041-1975cd143852","deploymentId":"967ebcc2-d990-4fbc-86c0-5720abfc678f","companyId":"10c41dfa-9a1d-4e6a-a63a-901375715bd7","dataCenterId":null,"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":"2026-07-03T16:14:24.757Z","updatedAt":"2026-09-29T20:00:54.191Z","model":{"id":"b2d13502-17cd-4a08-a041-1975cd143852","companyId":"10c41dfa-9a1d-4e6a-a63a-901375715bd7","modelName":"Butterfly AI Ultrasound","slug":"butterfly-ai-ultrasound","description":"Butterfly Network develops AI-powered handheld ultrasound technology, including the [Butterfly iQ+](/models/butterfly-ai-ultrasound) and Butterfly iQ3 probes that enable whole-body imaging from a single semiconductor-based device. Founded in 2011 by Dr. Jonathan Rothberg, the company went public via a $1.5B SPAC merger with Longview Acquisition Corp. in February 2021 and trades on NYSE under BFLY. The company has received multiple FDA clearances for AI-powered ultrasound tools and deploys across health systems including [Atrium Health](https://atriumhealth.org) and Hennepin EMS.","formFactor":"biometric","industryVertical":null,"environment":null,"maturityStage":"commercial","lifecycleState":"active","supersededByModelId":null,"specs":{},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://www.reuters.com/business/healthcare-pharmaceuticals/butterfly-network-gets-fda-clearance-ai-ultrasound-pregnancy-tool-2026-03-30/","title":"Butterfly Network gets FDA clearance for AI ultrasound pregnancy tool","sourceName":"Reuters"},{"url":"https://www.butterflynetwork.com/iq-plus","title":"iQ+ Ultrasound","sourceName":"Butterfly Network"},{"url":"https://www.butterflynetwork.com/iq3","title":"iQ3 Ultrasound","sourceName":"Butterfly Network"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"manufacturerTermForTeleop":null,"keyFacts":[{"label":"Type","value":"AI-powered portable ultrasound"},{"label":"Single-probe ultrasound","value":"Butterfly describes iQ+ as a handheld ultrasound device using a single Ultrasound-on-Chip probe for multiple imaging types across the body ([Butterfly iQ+](https://www.butterflynetwork.com/iq-plus)).","sourceUrl":"https://www.butterflynetwork.com/iq-plus"},{"label":"Point-of-care workflow","value":"Butterfly says iQ+ connects to compatible iOS or Android devices through the Butterfly app and supports clinical imaging presets and workflow tools ([Butterfly iQ+](https://www.butterflynetwork.com/iq-plus)).","sourceUrl":"https://www.butterflynetwork.com/iq-plus"}],"createdAt":"2026-07-03T16:14:15.301Z","updatedAt":"2026-09-29T20:23:41.242Z","unitsInFieldClaimed":null,"unitsInFieldVerified":null,"unitsManufacturedClaimed":null,"unitsManufacturedVerified":null,"unitsAsOf":null,"unitsSource":null,"salesModel":null,"priceUndisclosedSince":null,"autonomyClass":null,"autonomyStatement":null,"autonomyStatementSource":null,"demoForensics":null,"exportControlClass":null,"minCommitment":null,"warrantyTerms":null,"serviceModel":null,"productionRateClaimed":null,"productionRateEvidenced":null,"teleopRatioDisclosed":null,"interventionRateDisclosed":null},"deployment":{"id":"967ebcc2-d990-4fbc-86c0-5720abfc678f","modelId":"aed64d0b-bb26-4f48-8a32-1a6a7187fdbd","versionId":null,"locationId":"131f30d3-6e7e-4055-959a-2caec70e29a1","operatorId":"10c41dfa-9a1d-4e6a-a63a-901375715bd7","ownerId":null,"slug":"butterfly-iq-plus-south-africa-south-africa","status":"operational","firstSeen":"2023-01-01T00:00:00.000Z","statusChangeReason":null,"contractType":null,"pilotOutcome":null,"endedAt":null,"unitsOnSite":null,"tasksPerformed":["autonomous_operation"],"shiftStructure":null,"hoursPerDay":24,"siteType":"office","operatorConfirmed":false,"humanSupervisionOnsite":null,"locationPrecisionTier":"verified_coordinates","deploymentScale":"medium_11_100","siteEnvironment":"indoor","operatorType":"maker_operated","sourceQualityTier":2,"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://www.butterflynetwork.com/press-releases/butterfly-gusi-chai-500-probes-south-africa","label":"Butterfly, CHAI, and GUSI Partner to Advance Maternal and Fetal Health in South Africa","title":"Butterfly, CHAI, and GUSI Partner to Advance Maternal and Fetal Health in South Africa","mediaType":"article","sourceName":"Butterfly Network","publishedAt":"2023-01-01"}],"notes":"Butterfly partnered with CHAI and GUSI to deploy probes for maternal and fetal health in South Africa, funded by the Gates Foundation grant.","keyFacts":[],"reviewNote":null,"exposureHours":null,"deploymentMilesEstimate":null,"exposureBasis":null,"customerSegment":"research","scaleTier":"commercial_10_99","contractValueUsd":null,"contractValueBasis":null,"customerCompanyId":null,"customerExternalName":null,"createdAt":"2026-07-03T17:06:14.140Z","updatedAt":"2026-08-21T14:22:57.611Z"},"company":{"id":"10c41dfa-9a1d-4e6a-a63a-901375715bd7","name":"Butterfly Network","slug":"butterfly-network","description":"Butterfly Network develops AI-powered handheld ultrasound technology, including the [Butterfly iQ+](/models/butterfly-ai-ultrasound) and Butterfly iQ3 probes that enable whole-body imaging from a single semiconductor-based device. Founded in 2011 by Dr. Jonathan Rothberg, the company went public via a $1.5B SPAC merger with Longview Acquisition Corp. in February 2021 and trades on NYSE under BFLY. The company has received multiple FDA clearances for AI-powered ultrasound tools and deploys across health systems including [Atrium Health](https://atriumhealth.org) and Hennepin EMS.","status":"public","founded":2011,"hq":"Burlington, MA, USA","hqLat":42.5048167,"hqLng":-71.1956111,"hqGeocodedAt":"2026-08-05T00:50:45.528Z","hqAddress":null,"hqPrecision":null,"website":"butterflynetwork.com","fundingTotal":"1030000000","type":"hardware","roles":["robot_maker","robot_operator"],"reviewStatus":"reviewed","heatIndex":77,"lifecycleState":"active","supersededByCompanyId":null,"sources":[{"url":"https://www.reuters.com/business/healthcare-pharmaceuticals/butterfly-network-gets-fda-clearance-ai-ultrasound-pregnancy-tool-2026-03-30/","title":"Butterfly Network gets FDA clearance for AI ultrasound pregnancy tool","sourceName":"Reuters"}],"keyFacts":[{"label":"CEO","value":"Joseph M. 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The tool uses deep learning with Butterfly ultrasound systems to estimate gestational age ([FDA K252148](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252148.pdf)).","identifier":"25f63aab-17ed-453d-893b-d15a6142d0bc","datePublished":"2026-03-30T12:00:00.000Z","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":3,"primary_source_types":["primary-fda-database","secondary-established-publication"]}}}