Most medical devices developed in the U.S. reach the market through the 510(k) pathway, in which manufacturers prove that technology in their device is "substantially equivalent" to one or more predicates—existing devices ...
Jan 10, 2023
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Researchers have developed a novel device that detects abnormal breathing sounds to predict whether an ICU patient is likely to suffer from respiratory complications after removal from a mechanical ventilator, alerting intensive ...
Dec 16, 2022
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Researchers at the UPV/EHU-University of the Basque Country have developed a microfluidic plasma separator to optically detect blood biomarkers
Dec 12, 2022
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Lasik eye surgery is a common vision-correcting procedure that many Americans view as safe and effective, but the U.S. Food and Drug Administration has now drafted guidance that warns of potential complications.
Dec 8, 2022
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The U.S. Food and Drug Administration's foods program is in "constant turmoil" and needs stronger leadership, a panel said Thursday.
Dec 7, 2022
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Clinical trials are critical to the development and approval of medical treatments, whether those are drugs, vaccines or medical devices. It is challenging to recruit certain people for clinical trials for different reasons, ...
Dec 1, 2022
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Recently, consumer wearables have created the vision of new possibilities for personal care. Routine monitoring of biological signals such as heart rate or sleep pattern using wearable devices is an emerging trend in health ...
Nov 15, 2022
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Georgios Sotiriou, principal researcher at the Department of Microbiology, Tumor and Cell Biology, and his colleagues have developed a durable coating for medical devices which is activated by light, providing on-demand disinfection.
Nov 2, 2022
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Small leadless implanted electronic devices (LLIEDs) have emerged as a safer alternative to lead-dependent cardiac rhythm-management devices, with advancements in miniaturization, battery technology, and communication. Intrathoracic ...
Oct 28, 2022
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Clinical trials are critical to understanding the benefits of new treatments and medical therapies, but researchers say people who design and run clinical trials need to lift their game when it comes to recording and reporting ...
Oct 27, 2022
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