BfArM RSS-Feed: Medical Devices
- Notification of interruptions or discontinuations of the supply of a medical device
- DiGA and DiPA
- Critical vulnerabilities in the real-time operating systems of various venders
- Updated BfArM recommendation
- Damage of hip stem prostheses (neck area) caused by high-frequency cauterizing instruments (e. g. cautery knife)
- MIR-Changelog
- MIR changelog
- BfArM Recommendations
- Exemption criteria and risk assessment summary within clinical investigations or performance evaluation studies
- Troubleshooting: View PDF documents with Firefox
FDA D.I.S.C.O
- FDA D.I.S.C.O. Burst Edition: FDA approval of Ryoncil (remestemcel-L-rknd) for steroid-refractory acute graft versus host disease in pediatric patients
- FDA D.I.S.C.O. Burst Edition: FDA approval of Bizengri (zenocutuzumab-zbco) for Treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy
- FDA D.I.S.C.O. Burst Edition: FDA approval of Tecelra (afamitresgene autoleucel) for unresectable or metastatic synovial sarcoma
- FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) for unresectable advanced or metastatic malignant pleural mesothelioma
- FDA D.I.S.C.O. Burst Edition: FDA approvals of Augtyro (repotrectinib) for NTRK gene fusion-positive solid tumors and Krazati (adagrasib) for KRAS G12C-mutated colorectal cancer
- FDA D.I.S.C.O. Burst Edition: FDA approval of Retevmo (selpercatinib) for advanced or metastatic RET fusion-positive thyroid cancer
- FDA D.I.S.C.O. Burst Edition: FDA approval of Ojemda (tovorafenib) for relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion or rearrangement, or BRAF V600 mutation
MedWatch Safety Alerts RSS Feed
- ICU Medical Issues Nationwide Recall of Potassium Chloride Injection, 20 mEq and Potassium Chloride Injection, 10 mEq Due to Mislabeling
- Heart Pump Recall: Abiomed, Inc. Updates Use Instructions for Impella RP with SmartAssist and Impella RP Flex with SmartAssist Due to A Risk That the Tip of Guidewires or Other Medical Devices May Come into Contact with The Impella Pump During Insertion, Adjustment, Or Removal
- Breathing Circuit Kit Recall: Sentec/Percussionaire Removes VDR4 Phasitron Breathing Circuits due to Venturi Component Malfunctions that May Reduce Pressure and Volume Flow
- Arterial Catheter Recall: Medline Industries, LP, Removes Integrated Arterial Catheters due to Excess Material at Catheter Hub that May Detach
- Early Alert: Atherectomy Catheter System Issue from Bard Peripheral Vascular