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Medtronic MiniMed Pump Recall is Class 1

[ Price : $8.95]

FDA says a Medtronic recall of its MiniMed insulin pumps due to potential cybersecurity risks is Class 1.

Warren, Murray Want More Device Approval Answers

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Sens. Warren and Murray raises objections to and questions about an FDA proposal for a progressive approval pathway for medical de...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes one medical product company Bingbing Pharmaceutical.

FDAers Look at Oncology Drug Clinical Holds

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CDER researchers look at why oncology INDs are placed on clinical hold.

Fagron Recalls Lets Gel Convenience Packs

[ Price : $8.95]

Fagron recalls its Lets Gel Kit Convenience Packs due to potential microbial contamination of non-sterile products.

Philips Recalls Forte Gamma Camera System

[ Price : $8.95]

Philips Medical Systems recalls (Class 1) the Forte Gamma Camera System due to a nonconforming material/component.

RedHill Bio Gains H. Pylori Approval

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FDA approves a RedHill Biopharma NDA for Talicia (omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules for tr...

DiFusion Spinal Interbody Device Cleared

[ Price : $8.95]

FDA clears a DiFusion 510(k) for the Xiphos-ZF Spinal interbody device.

Abbott Recalls CentriMag Circulatory Support System

[ Price : $8.95]

Abbott recalls its CentriMag Acute Circulatory Support System due to a calibration system error.

Aveo Planning Tivozanib NDA Despite FDA Objections

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FDA says a requested clinical trial did not alleviate an overall survival trend that it was concerned with in an earlier Aveo Onco...