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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
7 Ways to Permanently Banish Belly Fat
Sixty-nine percent of Americans adults are overweight, and over 35 percent are obese. Obesity increases your risk for numerous conditions including heart disease, stroke, Type 2 diabetes, high blood pressure, and cancer.
Sadly, about 3.4 million adults die each year from being overweight or obese. Globally obesity now kills about the same as tobacco and all wars, terrorism and violence. Nearly all people who are overweight already have "pre-diabetes" and have significant risks of disease and death. They just don't know it.
When you begin to put on weight, especially lethal belly fat, your biology shifts out of balance, v...
Source: Healthy Living - The Huffington Post - February 27, 2015 Category: Consumer Health News Source Type: news
The Bariatric Patient: An Overview of Perioperative Care
Obesity (ie, a body mass index of ≥30 kg/m2) is increasing in the United States. As a result, more overweight individuals are being surgically treated for weight loss, thus making it imperative for perioperative RNs to understand obesity’s effects on patients’ health, its contribution to significant comorbidities (eg, diabetes, cardiovascular disease, hypertension, sleep apnea, musculoskeletal issues, stroke), the perioperative care requirements (eg, specialized instruments and equipment, positioning and lifting aids), and unique needs of these patients (eg, diet, counseling).
Source: AORN Journal - July 28, 2015 Category: Nursing Authors: Jennifer L. Fencl, Angela Walsh, Dawn Vocke Tags: Featured article Source Type: research
