Studies use retinal scans to potentially identify earlier signs of Alzheimer’s disease
October 30, 2018
By Neozene

Two studies showed that noninvasive eye scans measuring the thickness of the retina can provide a window into the early signs of Alzheimer’s disease, with the goal of providing a quick, inexpensive test for identifying those at a higher risk. By using optical coherence tomography angiography, or OCT scans, researchers observed cross sections of patients’ retinas, visualizing the changes seen in its smallest blood vessels. They believe that the deterioration of the retina may mirror the disease’s progression in the brain, conveyed across the optic nerve. The researchers were able

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US FDA Clarifies Human Subject Requirements for Clinical Investigations
October 23, 2018
By Neozene

New guidance from the US Food and Drug Administration explains how its clinical investigation requirements pertaining to human subject protection policies correspond to US federal policy on human subject protections enforced by the Department of Health and Human Services (HHS). The guidance is intended to explain how sponsors whose medical device and pharmaceutical clinical investigations must meet both FDA clinical investigation regulations for human subject safety and informed consent as well as HHS’s “Common Rule” for human subject protections should address compliance issues. In general, the guidance recommends that in

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10,000-patient Apple Watch study in hip and knee surgeries
October 16, 2018
By Neozene

Apple and Zimmer Biomet have begun collaborating on a large clinical study that will use an Apple Watch and iPhone app to help prepare and track patients through hip and knee replacement surgeries—with the goal of adding digital health products and active engagement to a new standard of care. The multiyear trial, which aims to enroll as many as 10,000 participants, will study Zimmer Biomet’s mymobility app and its impacts on recovery and overall costs, by combining patient-reported feedback with heart rate and movement data collected both pre- and postsurgery.

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