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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
The Man Who Grew Eyes
The train line from mainland Kobe is a marvel of urban transportation. Opened in 1981, Japan’s first driverless, fully automated train pulls out of Sannomiya station, guided smoothly along elevated tracks that stand precariously over the bustling city streets below, across the bay to the Port Island. The island, and much of the city, was razed to the ground in the Great Hanshin Earthquake of 1995 – which killed more than 5,000 people and destroyed more than 100,000 of Kobe’s buildings – and built anew in subsequent years. As the train proceeds, the landscape fills with skyscrapers. The Rokkō mounta...
Source: Science - The Huffington Post - October 11, 2015 Category: Science Source Type: news
Stem Cells for Cell-Based Therapies
The world of stem cells
We know the human body comprises many cell types (e.g., blood cells, skin cells, cervical cells), but we often forget to appreciate that all of these different cell types arose from a single cell—the fertilized egg. A host of sequential, awe-inspiring events occur between the fertilization of an egg and the formation of a new individual:
Embryonic stem (ES) cells are also called totipotent cells.
The first steps involve making more cells by simple cell division: one cell becomes two cells; two cells become four cells, etc.
Each cell of early development is undifferentiated; that is, it is...
Source: ActionBioscience - December 28, 2012 Category: Science Authors: Ali Hochberg Source Type: news
