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FDA Approvals - FDA Approves Software Update That Identifies Potential Defibrillator Lead Fractures


FDA Approves Software Update That Identifies Potential Defibrillator Lead Fractures (Medical News Today)
The U.S. Food and Drug Administration announced approval of a software update from Medtronic that will help detect fractures of the company's Sprint Fidelis cardiac defibrillator lead. The new software package will alert both patients and physicians of a potential lead fracture. This will enable early intervention and lower the risk of serious complications.

FDA Starts Reporting Drugs Under Safety Investigation (Medical News Today)
On Friday 5th September, in line with new legislation introduced last year, the US Food and Drug Administration (FDA) posted the first of its quarterly reports on the drugs it is investigating for safety reasons because of post marketing adverse events reports it has received from patients and doctors.
 

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