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Battery Performance and Cybersecurity Firmware Updates for Abbott Implantable Cardiac Devices

in Pharmaceutical News
Battery Performance Alert and Cybersecurity Firmware Updates for Certain Abbott Implantable Cardiac Devices

The FDA approved a firmware update that is now available and is intended as a corrective action (recall), to reduce the risk of patient harm due to premature battery depletion and potential exploitation of cybersecurity vulnerabilities for certain Abbott ICDs and CRT-Ds. “Firmware” is a specific type of software embedded in the hardware of a medical device (e.g. a component in the defibrillator). The FDA recommends that all eligible patients receive the firmware update at their next regularly scheduled visit…

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FDA permits marketing of AI-based device to detect diabetes-related eye problems

in Pharmaceutical News

The U.S. Food and Drug Administration permitted marketing of the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes. Diabetic retinopathy occurs when high levels of blood sugar lead to damage in the blood vessels of the retina, the light-sensitive tissue in the back of the eye. Diabetic retinopathy is the most common cause of vision loss among the more than 30 million Americans…

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