secwatch / observer

8-K filed August 7, 2024, 7:59 PM ET ticker ALUR CIK 0001964979

regulatory confidence high sentiment negative materiality 0.85

Allurion Balloon sales suspended in France; device withdrawn pending remediation plan

ALLURION TECHNOLOGIES, INC.

French regulator ANSM suspended sales; Allurion withdrawing device from French market.
Company cites 20 peer-reviewed articles and 150,000+ patients treated to support safety profile.
Complication rates in line with published literature and lower than other weight loss products.
Allurion cooperating with ANSM on remediation plan for advertising, follow-up, and training.
Company disagrees with decision but seeks path to resume commercialization in France.

Machine-readable event card

schema_version: secwatch.filing_event.v1
accession: 0000950170-24-093016
form_type: 8-K
ticker: ALUR
cik: 0001964979
company_name: ALLURION TECHNOLOGIES, INC.
filed_at: 2024-08-07T23:59:59+00:00
discovered_at: 2026-05-14T18:03:15.287880+00:00
generated_at: 2026-05-31T11:55:34.814443+00:00
sec_items: ["8.01"]
event_type: regulatory
sentiment: negative
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: high
secwatch_canonical_url: https://secwatch.observer/filing/0000950170-24-093016
json_url: https://secwatch.observer/filing/0000950170-24-093016.json
markdown_url: https://secwatch.observer/filing/0000950170-24-093016.md
text_url: https://secwatch.observer/filing/0000950170-24-093016.txt
edgar_index_url: https://www.sec.gov/Archives/edgar/data/1964979/000095017024093016/0000950170-24-093016-index.htm
edgar_primary_document_url: https://www.sec.gov/Archives/edgar/data/1964979/000095017024093016/alur-20240806.htm
generated_by_model: deepseek-v4-flash:cloud@v2
review_status: machine_generated
human_reviewed: false
corrected: false
correction_note: null
correction_timestamp: null
superseded_by: null

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Source: SEC EDGAR

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