by British Medical Journal Credit: Unsplash/CC0 Public Domain More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) within the deadline set by federal regulations, finds an analysis of recent data published by The BMJ. Of these late reports, more than 400,000 were submitted more than six...
Tag: <span>medical device</span>
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FDA gets over 21,000 medical device reports, including 124 deaths, linked to Philips foam breakdown
Published May 20, 2022 Ricky Zipp Reporter Philips Dive Brief: The Food and Drug Administration released new data about medical device reports associated with Philips Respironics’ ongoing sleep apnea and ventilator recall, including more than 100 cases of patient deaths and tens of thousands of total reports. Between April 2021 and April 30, 2022, the FDA received...
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Researchers developed a new medical device to replace the stethoscope
What are the first thoughts that spring to mind when thinking about physicians? Probably white coats and a doctor’s most trusty tool, the stethoscope. Now more than 200 years old, this examination aid remains one of the essential tools of the physician, even though the device itself has hardly developed since the 1960s. An innovation...
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FDA warns of cyber vulnerabilities in medical device software components
Greg Slabodkin Senior Editor JuSun via Getty Images Dive Brief: FDA on Tuesday issued a cybersecurity alert warning about seven vulnerabilities in software company PTC’s Axeda agent and desktop server, third-party components that enable remote service via the internet, which are used in medical devices from several manufacturers. The agency said if the vulnerabilities in the web-based agent and desktop...
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Compact, Consumer “Stemoscope” Recently Launched: A Medgadget Review
While it is not intended to be used as a medical device or diagnostic tool, Hulu Devices has created a stethoscope for consumer use. The device itself looks like simply the head of a stethoscope, and is about the size of a watch face. Connection to this device is via Bluetooth to the Stemoscope app...