Murilo Freitas – Page 2

FDA Authorizes Marketing of First Eyeglass Lenses to Slow Progression of Pediatric Myopia

Murilo Freitas - 18:01, 24 de September de 202553

FDA Authorizes Marketing of First Eyeglass Lenses to Slow Progression of Pediatric Myopia
http://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-first-eyeglass-lenses-slow-progression-pediatric-myopia

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FDA Removes Risk Evaluation and Mitigation Strategies (REMS) for Caprelsa (vandetanib)

Murilo Freitas - 17:57, 24 de September de 202598

FDA Removes Risk Evaluation and Mitigation Strategies (REMS) for Caprelsa (vandetanib)
http://www.fda.gov/news-events/press-announcements/fda-removes-risk-evaluation-and-mitigation-strategies-rems-caprelsa-vandetanib

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Blood and Plasma Warming Device Correction: 3M Company Issues Correction for Ranger Blood/Fluid Warming System

Murilo Freitas - 04:00, 23 de September de 2025105

3M is correcting their Ranger Blood/Fluid Warming System due to incomplete temperature and flow rate specifications on the label.

http://www.fda.gov/medical-devices/medical-device-recalls/blood-and-plasma-warming-device-correction-3m-company-issues-correction-ranger-bloodfluid-warming

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Early Alert: Automated Impella Controller Purge Retainer Fixation Issue from Abiomed

Murilo Freitas - 04:00, 22 de September de 202594

FDA is announcing an Early Alert for Abiomed’s Automated Impella Controller due to Purge Pressure Issues

http://www.fda.gov/medical-devices/medical-device-recalls/early-alert-automated-impella-controller-purge-retainer-fixation-issue-abiomed

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FDA Responds to Evidence of Possible Association Between Autism and Acetaminophen Use During Pregnancy

Murilo Freitas - 21:16, 21 de September de 2025102

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

Murilo Freitas - 21:16, 21 de September de 202579

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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Olympus Issues Voluntary Recall for Specific Lots of ViziShot 2 FLEX (19G) EBUS -TBNA Needles

Murilo Freitas - 04:00, 21 de September de 202567

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

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/olympus-issues-voluntary-recall-specific-lots-vizishot-2-flex-19g-ebus-tbna-needles

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FDA Grants Accelerated Approval to First Treatment for Barth Syndrome

Murilo Freitas - 20:47, 18 de September de 202592

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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Early Alert: TactiFlex Ablation Catheter Issue from Abbott

Murilo Freitas - 04:00, 17 de September de 202593

Abbott has issued new instructions on removing TactiFlex Ablation Catheter, Sensor Enabled from its packaging due to tip detachment issues

http://www.fda.gov/medical-devices/medical-device-recalls/early-alert-tactiflex-ablation-catheter-issue-abbott

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FDA Updates Warning About Imported Cookware That May Leach Lead: August 2025

Murilo Freitas - 04:00, 16 de September de 2025100

FDA Updates Warning About Imported Cookware That May Leach Lead: August 2025. Retailers Should Not Sell and Consumers Should Not Use Certain Cookware Because of Their Potential to Leach Lead into Food When Cooking

http://www.fda.gov/safety/medical-product-safety-information/fda-updates-warning-about-imported-cookware-may-leach-lead-august-2025