{"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":"Butterfly Network received FDA clearance for AI-powered ultrasound tool for fetal biometric measurements. Trained on 21M+ images. Delivers estimate in under 2 minutes.","occurredAt":"2026-03-30T12:00:00.000Z","reviewStatus":"unreviewed","modelId":null,"deploymentId":null,"companyId":"10c41dfa-9a1d-4e6a-a63a-901375715bd7","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,"createdAt":"2026-07-03T16:14:24.757Z","updatedAt":"2026-07-03T16:14:24.757Z","model":null,"deployment":null,"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":null,"founded":2011,"hq":"Burlington, MA, USA","fundingTotal":"1030000000","type":"hardware","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"}],"keyFacts":[{"label":"CEO","value":"Joseph M. DeVivo"},{"label":"Founder","value":"Dr. Jonathan Rothberg"},{"label":"Stock","value":"NYSE: BFLY"},{"label":"Revenue 2025","value":"97.6M USD (company-reported)"},{"label":"Technology","value":"Ultrasound-on-Chip semiconductor"},{"label":"Ticker","value":"BFLY (NYSE)"},{"label":"SPAC merger date","value":"2021-02-16 (Longview Acquisition Corp, $1.5B valuation)"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"createdAt":"2026-07-03T16:14:15.145Z","updatedAt":"2026-07-03T17:06:46.751Z"},"derived":{"status":"active"},"sources":[{"id":"e11033af-48e7-4cf9-87cc-672de6a2e7b6","incidentId":"25f63aab-17ed-453d-893b-d15a6142d0bc","url":"https://www.reuters.com/business/healthcare-pharmaceuticals/butterfly-network-gets-fda-clearance-ai-ultrasound-pregnancy-tool-2026-03-30/","label":null,"publishedAt":null,"notes":null,"title":"Butterfly Network gets FDA clearance for AI ultrasound pregnancy tool","sourceName":"Reuters","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-03T16:14:24.948Z","updatedAt":"2026-07-03T16:14:24.948Z"}],"responses":[],"statusEvents":[{"id":"0fa1fc08-2a86-4f1b-92ef-3b8e944a6159","incidentId":"25f63aab-17ed-453d-893b-d15a6142d0bc","status":"active","reason":null,"source":"agent:depth","effectiveAt":"2026-07-03T16:14:25.105Z","createdAt":"2026-07-03T16:14:25.106Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/regulatory-action-2026-03-30-butterfly-network","url":"https://registry.deploy.report/incidents/regulatory-action-2026-03-30-butterfly-network","headline":"Butterfly Network receives FDA clearance for AI ultrasound fetal biometric tool","description":"Butterfly Network received FDA clearance for AI-powered ultrasound tool for fetal biometric measurements. Trained on 21M+ images. Delivers estimate in under 2 minutes.","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":"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":["secondary-established-publication"]}}}