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FDA Alert: Abiomed Impella Blood Pump Controller

by Devices and Pharma | Jul 8, 2025 | Alerts-Device, Class I Recalls, FDA Safety Communication, Med-Devices, MedWatch-System, Product Recalls, Product Safety

FDA Alert: Abiomed Impella Blood Pump Urgent Recall Controller may fail to detect the Impella device Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Abiomed Impella blood pump controllers...

China Implements a Ban on European Medical Devices

by Devices and Pharma | Jul 8, 2025 | Global-RA, Industry Information, Industry News

China Retaliates Against European Union Device Manufacturers Imposes a ban on European medical devices Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Growing China-EU Trade Conflict The medical...

GE HealthCare Anesthesia Systems Recall Due to Ventilation Risk

by Devices and Pharma | Jul 7, 2025 | Alerts-Device, Class I Recalls, FDA Safety Communication, Industry News, Product Recalls, Products_Devices

GE HealthCare Anesthesia Systems Recall potentially life-threatening risk in Volume Control Ventilation (VCV) mode Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact GE Carestation Anesthesia...

FDA Approves DATROWAY® Breast Cancer Treatment

by Devices and Pharma | Jul 7, 2025 | FDA Approvals, FDA_Innovation, Industry News, New Drugs, New Pharma Products, Pharmaceuticals, Product-Innovation, US-FDA

FDA Approves DATROWAY® for Advanced HR+/HER2- Breast Cancer Trop-2-directed antibody-drug conjugate Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact A new breast cancer treatment option The United...

A Dangerous and Unapproved Drug Sold as a “Cure”

by Devices and Pharma | Jul 5, 2025 | Consumer Information, Consumer Safety, Product Safety

Tianeptine: A Dangerous and Unapproved Drug Sold as a “Cure” What you need to know Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact The dangers of tianeptine FDA warns that tianeptine is sold...
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