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Medtech approvals: FDA releases August 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in August 2015:
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 70
Summary of PMA Originals Under Review
Total Under Review: 57
Total Active: 28
Total On Hold: 29
Summary of PMA Supplements Under Review
Total Under Review: 569
Total Active: 422
Total On Hold: 147
Summary of All PMA Submissions
Originals: 5
Supplements: 90
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 70
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 229.0
FDA Time: 130...
Source: Mass Device - October 23, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Source Type: news
No pain, no gain? Getting the most out of exercise
Staying in shape has all sorts of benefits, from maintaining heart health to warding off dementia and cancerInactivity – fuelled by cars and a sedentary work life – has been dubbed the biggest public health problem of the 21st century, a global pandemic with dramatic impact on peoples wellbeing. The latest reports suggest that around the world it was responsible for 5.3 million deaths in 2008 – around one in 10 – more deaths than smoking.Not only does exercise make you fitter, it can also ward off numerous and often unexpected diseases, from heart attacks, to diabetes, some forms of cancer and dementia. There are t...
Source: Guardian Unlimited Science - January 13, 2014 Category: Science Authors: Catherine de Lange Tags: Cycling Fitness Sport Running Transport Yoga Weightlifting Features UK news Life and style Cycle hire schemes The Observer Swimming Science Source Type: news
Osteoporosis and Sarcopenia Increase Frailty Syndrome in the Elderly
Conclusions
World population is aging and the increase in life expectancy is often unhealthy. In particular, musculoskeletal aging, which leads to sarcopenia and osteoporosis, has several causes such as changes in body composition, inflammation, and hormonal imbalance. Sarcopenia, osteoporosis, and more frequently, sarcopenic obesity are commonly associated with aging and frequently closely linked each other, often leading to the development of a frailty syndrome. Frailty syndrome favors an increased risk of loss function in daily activities, for cardiovascular diseases, cancers, falls, and mortality. As the number of eld...
Source: Frontiers in Endocrinology - April 23, 2019 Category: Endocrinology Source Type: research
