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FDA Alerts: Cardiology Roundup, Summer 2023

FDA Scolds Abiomed for Not Seeking a PMA for Its Web-Based User Portal

The warning letter is the latest indication of the fresh scrutiny the FDA is paying to software tools and decision aids.

10 Most Recent Medical Safety Recalls: August 17, 2023 – 24/7 Wall St

The U.S. Food and Drug Administration (FDA) issues safety alerts as needed to provide timely new safety information on human drugs, medical devices, vaccines, and other products, including biologics, dietary supplements, and cosmetics. The alerts are publicly available at the agency’s MedWatch website and contain “actionable information that may impact both treatment and diagnostic choices […]

10 Most Recent Medical Safety Recalls: August 11, 2023 – 24/7 Wall St

The U.S. Food and Drug Administration (FDA) issues safety alerts as needed to provide timely new safety information on human drugs, medical devices, vaccines, and other products, including biologics, dietary supplements, and cosmetics. The alerts are publicly available at the agency’s MedWatch website and contain “actionable information that may impact both treatment and diagnostic choices […]

10 Most Recent Medical Safety Recalls: July 18, 2023 – 24/7 Wall St

The U.S. Food and Drug Administration (FDA) issues safety alerts as needed to provide timely new safety information on human drugs, medical devices, vaccines, and other products, including biologics, dietary supplements, and cosmetics. The alerts are publicly available at the agency’s MedWatch website and contain “actionable information that may impact both treatment and diagnostic choices […]

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