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Incident · Regulatory action

Butterfly Network receives FDA clearance for AI ultrasound fetal biometric tool

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).

Occurred 2026-03-30 · Butterfly iQ+ at South Africa · Butterfly Network · South Africa · Biometric wearables · Investigated by FDA

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Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.
Track Butterfly Network receives FDA clearance for AI ultrasound fetal biometric tool

Machine-readable surfaces

Sources (3)

  1. https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252148.pdf · 2026-03-27
  2. https://www.accessdata.fda.gov/cdrh_docs/cfdocs/cfPMN/pmn.cfm?ID=K252148 · 2026-03-27
  3. https://www.reuters.com/business/healthcare-pharmaceuticals/butterfly-network-gets-fda-clearance-ai-ultrasound-pregnancy-tool-2026-03-30/

Status history

  • Active · 2026-07-03 · agent:depth

Common questions

What happened in Butterfly Network receives FDA clearance for AI ultrasound fetal biometric tool?
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)).
When did this incident occur?
The incident is recorded as occurring on March 30, 2026 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in Butterfly Network receives FDA clearance for AI ultrasound fetal biometric tool?
Butterfly iQ+ by Butterfly Network is the recorded robot involved in this incident at South Africa.
Has anyone responded to Butterfly Network receives FDA clearance for AI ultrasound fetal biometric tool?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of Butterfly Network receives FDA clearance for AI ultrasound fetal biometric tool?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 3 sources (2 primary) · last reviewed 2026-09-29

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-09-29

Sources by quality tier

2
primary-fda-database
FDA database
1
secondary-established-publication
Established publication

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for Butterfly Network receives FDA clearance for AI ultrasound fetal biometric tool.

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Canonical ID 25f63aab-17ed-453d-893b-d15a6142d0bc