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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
A Review of Mathematical Models for Muscular Dystrophy: A Systems Biology Approach
Discussion
With new developments in computational power and data availability, a growing amount of research is using a systems biology approach to understand pathogenesis and progression of disease. Effective and integrated in vitro and in silico models could inform biological phenomena, even without the need of a living subject. For instance, over the last few decades, collagen hydrogel with muscle derived cells (CHMDCs) have promised to revolutionize in vitro experiments and tissue engineering. For CHMDCs to reach the envisioned use, verification by use of mathematical simulations are needed. Recently while examining sha...
Source: PLOS Currents Muscular Dystrophy - February 16, 2018 Category: Neurology Authors: Matthew Houston Source Type: research
Device that measures cell strength could help identify drugs for asthma, hypertension and muscular dystrophy
Engineers, doctors and scientists at UCLA and Rutgers University have developed a tool that measures the physical strength of individual cells 100 times faster than current technologies.The new device could make it easier and faster to test and evaluate new drugs for diseases associated with abnormal levels of cell strength, including hypertension, asthma and muscular dystrophy. It could also open new avenues for biological research into cell force. It is the first high-throughput tool that can measure the strength of thousands of individual cells at a time.“Our tool tracks how much force individual cells exert over time...
Source: UCLA Newsroom: Health Sciences - February 9, 2018 Category: Universities & Medical Training Source Type: news
How COVID-19 Changes the Heart —Even After the Virus Is Gone
While COVID-19’s effects on the lungs and respiratory system are well known, there is growing research suggesting that the virus is also affecting the heart, with potentially lasting effects.
In a presentation at the annual meeting of the Biophysical Society, an international biophysics scientific group, Dr. Andrew Marks, chair of the department of physiology at Columbia University, and his colleagues reported on changes in the heart tissue of COVID-19 patients who had died from the disease, some of whom also had a history of heart conditions. The team conducted autopsy analyses and found a range of abnormalities, pa...
Source: TIME: Health - February 18, 2023 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized COVID-19 healthscienceclimate Source Type: news
