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Early Alert: Automated Impella Controller Purge Retainer Fixation Issue from Abiomed
FDA is announcing an Early Alert for Abiomed’s Automated Impella Controller due to Purge Pressure Issues
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At UNGA 80 event, PAHO Director highlights critical link between infectious diseases and NCDs
At UNGA 80 event, PAHO Director highlights critical link between infectious diseases and NCDs
Cristina Mitchell
22 Sep 2025
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FDA Responds to Evidence of Possible Association Between Autism and Acetaminophen Use During Pregnancy
FDA Responds to Evidence of Possible Association Between Autism and Acetaminophen Use During Pregnancy
http://www.fda.gov/news-events/press-announcements/fda-responds-evidence-possible-association-between-autism-and-acetaminophen-use-during-pregnancy
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FDA Takes Action to Make a Treatment Available for Autism Symptoms
FDA Takes Action to Make a Treatment Available for Autism Symptoms
http://www.fda.gov/news-events/press-announcements/fda-takes-action-make-treatment-available-autism-symptoms
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PAHO Director calls for immediate action and stronger partnerships to reduce suicide in the Americas
PAHO Director calls for immediate action and stronger partnerships to reduce suicide in the Americas
Cristina Mitchell
22 Sep 2025
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Olympus Issues Voluntary Recall for Specific Lots of ViziShot 2 FLEX (19G) EBUS -TBNA Needles
CENTER VALLEY, Pa., (September 19, 2025) — Olympus Corporation has announced a voluntary, global medical device removal action for ViziShot 2 FLEX (19G) EBUS -TBNA needles (“ViziShot 2 FLEX”) manufactured prior to May 12, 2025, after receiving reports of device components detaching during procedures
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PAHO intensifies call to strengthen vaccination in light of rising measles cases in the Americas
PAHO intensifies call to strengthen vaccination in light of rising measles cases in the Americas
Cristina Mitchell
19 Sep 2025
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FDA Grants Accelerated Approval to First Treatment for Barth Syndrome
FDA Grants Accelerated Approval to First Treatment for Barth Syndrome
http://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-first-treatment-barth-syndrome
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UNGA: PAHO to join global call for action at High-level Meeting on NCDs and Mental Health
UNGA: PAHO to join global call for action at High-level Meeting on NCDs and Mental Health
Oscar Reyes
18 Sep 2025
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Early Alert: TactiFlex Ablation Catheter Issue from Abbott
Abbott has issued new instructions on removing TactiFlex Ablation Catheter, Sensor Enabled from its packaging due to tip detachment issues
