A study conducted by Regenstrief Institute research scientists to examine the use, by older adults with type 1 or type 2 diabetes, of continuous glucose monitors and other wearable devices to assess and manage low blood sugar, ...
Jan 26, 2023
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Manufacturers, through a loophole in the law, can use an unsafe medical device as a basis for U.S. Food and Drug Administration (FDA) authorization to sell the device, a new Yale-led study finds.
Jan 20, 2023
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The same devices used to take selfies and type out tweets are being repurposed and commercialized for quick access to information needed for monitoring a patient's health. A fingertip pressed against a phone's camera lens ...
Jan 18, 2023
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Imperial researchers have developed a low-cost, easy-to-manufacture stabilizer for broken bones to help in regions where such devices are expensive or in short supply and people sometimes resort to homemade options.
Jan 11, 2023
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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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