Murilo Freitas – Page 10

Outpatient Telemetry Correction: Philips Issues Correction for Monitoring Service Application used with Mobile Cardiac Outpatient Telemetry Due to Potential for Missed Information or Notifications That May Impact Patient Care

Murilo Freitas - 05:00, 13 de January de 2025205

Philips Monitoring Service Application processes mobile cardiac telemetry data but failed to send critical data for review by healthcare professionals.

http://www.fda.gov/medical-devices/medical-device-recalls/outpatient-telemetry-correction-philips-issues-correction-monitoring-service-application-used-mobile

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FDA Roundup: January 10, 2025

Murilo Freitas - 20:03, 9 de January de 2025150

FDA Roundup: January 10, 2025
http://www.fda.gov/news-events/press-announcements/fda-roundup-january-10-2025

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FDA Roundup: January 7, 2025

Murilo Freitas - 21:31, 6 de January de 2025217

FDA Roundup: January 7, 2025
http://www.fda.gov/news-events/press-announcements/fda-roundup-january-7-2025

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FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy: FDA Safety Communication

Murilo Freitas - 05:00, 6 de January de 2025188

FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy: FDA Safety Communication

http://www.fda.gov/safety/medical-product-safety-information/fda-requires-guillain-barre-syndrome-gbs-warning-prescribing-information-rsv-vaccines-abrysvo-and

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FDA Issues Draft Guidance on Including Tissue Biopsies in Clinical Trials

Murilo Freitas - 16:38, 5 de January de 2025214

FDA Issues Draft Guidance on Including Tissue Biopsies in Clinical Trials
http://www.fda.gov/news-events/press-announcements/fda-issues-draft-guidance-including-tissue-biopsies-clinical-trials

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FDA Proposes Framework to Advance Credibility of AI Models Used for Drug and Biological Product Submissions

Murilo Freitas - 15:28, 5 de January de 2025198

FDA Proposes Framework to Advance Credibility of AI Models Used for Drug and Biological Product Submissions
http://www.fda.gov/news-events/press-announcements/fda-proposes-framework-advance-credibility-ai-models-used-drug-and-biological-product-submissions

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FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices

Murilo Freitas - 15:16, 5 de January de 2025185

FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices
http://www.fda.gov/news-events/press-announcements/fda-issues-comprehensive-draft-guidance-developers-artificial-intelligence-enabled-medical-devices

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FDA Roundup: January 3, 2025

Murilo Freitas - 19:19, 2 de January de 2025147

FDA Roundup: January 3, 2025
http://www.fda.gov/news-events/press-announcements/fda-roundup-january-3-2025

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Early Alert: Solution Set Issue from Baxter Healthcare Corporation

Murilo Freitas - 05:00, 30 de December de 2024209

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

http://www.fda.gov/medical-devices/medical-device-recalls/early-alert-solution-set-issue-baxter-healthcare-corporation

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Early Alert: Extracorporeal Blood Circuit Issue from Nuwellis

Murilo Freitas - 05:00, 29 de December de 2024140

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

http://www.fda.gov/medical-devices/medical-device-recalls/early-alert-extracorporeal-blood-circuit-issue-nuwellis