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Early Alert: Arrow International Removes Dialysis Catheter Kits Containing Merit Medical Splittable Sheath Introducers

Murilo Freitas - 04:00, 23 de April de 2026102
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Arrow International is removing dialysis catheter kits containing recalled Merit Medical Splittable Sheath Introducers

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-arrow-international-removes-dialysis-catheter-kits-containing-merit-medical-splittable

 
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Early Alert: Automated Compounding System Issue from Omnicell

Murilo Freitas - 04:00, 23 de April de 2026110
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Certain labels used with i.V.Station automated compounding systems may not be detected, leading to mislabeled sterile filled syringes

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-automated-compounding-system-issue-omnicell

 
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FDA Approves First-Ever Gene Therapy for Treatment of Genetic Hearing Loss Under National Priority Voucher Program

Murilo Freitas - 19:25, 22 de April de 2026137
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FDA Approves First-Ever Gene Therapy for Treatment of Genetic Hearing Loss Under National Priority Voucher Program
http://www.fda.gov/news-events/press-announcements/fda-approves-first-ever-gene-therapy-treatment-genetic-hearing-loss-under-national-priority-voucher

 
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PAHO calls to strengthen vaccination amid rising measles cases in the Americas

admin - 15:34, 22 de April de 202668
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PAHO calls to strengthen vaccination amid rising measles cases in the Americas

Oscar Reyes

23 Apr 2026

 
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CMS and FDA Announce RAPID Coverage Pathway to Accelerate Patient Access to Life-Changing Medical Devices

Murilo Freitas - 12:50, 22 de April de 2026127
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CMS and FDA Announce RAPID Coverage Pathway to Accelerate Patient Access to Life-Changing Medical Devices
http://www.fda.gov/news-events/press-announcements/cms-and-fda-announce-rapid-coverage-pathway-accelerate-patient-access-life-changing-medical-devices

 
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Cranial Drill Recall: Integra LifeSciences Recalls Codman Disposable Perforators Due to Risk of Device Disassembly

Murilo Freitas - 04:00, 22 de April de 2026458
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Certain Codman Disposable Perforators may disassemble during or after use, increasing the risk of brain injury, hemorrhage, or prolonged surgery.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/cranial-drill-recall-integra-lifesciences-recalls-codman-disposable-perforators-due-risk-device

 
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Early Alert: Convenience Kit Issue from Aligned Medical Solutions

Murilo Freitas - 04:00, 22 de April de 202671
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The adaptor on Namic RA syringes may unwind during use. The resulting loose connection or disconnection may lead to infection, blood loss, or air embolism.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-convenience-kit-issue-aligned-medical-solutions

 
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WHO certifies the Bahamas for eliminating mother-to-child transmission of HIV

admin - 17:10, 21 de April de 202667
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WHO certifies the Bahamas for eliminating mother-to-child transmission of HIV

Cristina Mitchell

22 Apr 2026

 
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Insulin Pump Correction: Tandem Diabetes Care Issues Correction for Tandem Mobi Insulin Pumps

Murilo Freitas - 04:00, 21 de April de 202698
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Tandem is correcting Mobi insulin pumps operating on affected software versions (7.6.0.1, 7.6.0.3, and 7.7.0.1) which may incorrectly detect a motor issue.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/insulin-pump-correction-tandem-diabetes-care-issues-correction-tandem-mobi-insulin-pumps

 
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FDA Achieves Year 1 Goals in Reducing Animal Testing in Drug Development

Murilo Freitas - 15:12, 19 de April de 202698
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FDA Achieves Year 1 Goals in Reducing Animal Testing in Drug Development
http://www.fda.gov/news-events/press-announcements/fda-achieves-year-1-goals-reducing-animal-testing-drug-development

 
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