CLIMATE Artificial intelligence is often associated with ludicrous amounts of electricity, and therefore planet-heati…+ EDUCATION While many schools in England have banned smartphones, in Estonia – regarded as the new European education po… EDUCATION In a Cambridge classroom, Joseph, 10, trained his AI model to discern between drawings of apples and drawings… EDUCATION OpenAI CEO Sam Altman recently told a US podcast that if he was graduating today, “I would feel like the luck… EDUCATION I disagree with the decision of lecturers to use artificial intelligence to create teaching materials (‘We co… BUSINESS Americans are growing worried about what artificial intelligence portends for their futures. Eight in 10 Amer… BUSINESS Accenture has reportedly begun calling its near 800,000 employees “reinventors”, as the consultancy tries to… LABOR US workers overwhelmingly support pro-worker policies on artificial intelligence (AI) and view labor unions a…
TruaceTracing the truth around AISunday, July 12, 2026
TRV-2026-0043Version 1 · Certified

Written 2026-07-12 20:50:17 UTC · current record

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TRUVACE RECORD VERSION
record: TRV-2026-0043
version: 1
kind: certified
reason: Certified into the record
timestamp: 2026-07-12T20:50:17.844924Z
status: published
lens: p_space
sector: health
headline: Mitraclip® system clip delivery system: FDA injury report involving AI
dek: The FDA received a injury report involving Mitraclip® system clip delivery system, made by Abbott medical. The article, "predicting outcomes in patients with tricuspid regurgitation undergoing transcatheter edge-to-edge repair using an artificial intelligence¿derived risk score", was reviewed. this research article is a retrospective multicenter experience to evaluate and validate a robust, reliable risk score for predicting mortality and clinical outcomes in patients undergoing tricuspid- transcatheter edge-to-edge repa…
gain_reading: (none)
problem_reading: An FDA adverse-event report linked Mitraclip® system clip delivery system to an AI-related injury; the report requires investigation and does not by itself establish causality.
limitation: FDA adverse-event reports can be incomplete, duplicated, or unverified and do not establish that a device caused the reported outcome.
tag: Evidence-backed problem
key_points: Device: Mitraclip® system clip delivery system; manufacturer: Abbott medical. | FDA report type: Injury. | An adverse-event report is a safety signal, not proof that the device caused the event.
rundown: The article, "predicting outcomes in patients with tricuspid regurgitation undergoing transcatheter edge-to-edge repair using an artificial intelligence¿derived risk score", was reviewed. this research article is a retrospective multicenter experience to evaluate and validate a robust, reliable risk score for predicting mortality and clinical outcomes in patients undergoing tricuspid- transcatheter edge-to-edge repa…

The report is part of FDA’s MAUDE surveillance data. It should be read as a signal for follow-up, not a clinical conclusion or a verified incidence rate.
sources:
- government | FDA MAUDE report 24887023 | https://api.fda.gov/device/event.json?search=mdr_report_key%3A%2224887023%22&sort=date_received%3Adesc&limit=1 | 2026-04-15
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