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Source: Mass Device
Nutrition: Weight Loss
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Total 2 results found since Jan 2013.
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
Diabetes: Study finds bariatric surgery beats diet, exercise
A study designed to compare bariatric surgery with lifestyle interventions found that Type II diabetics treated with gastric bypass or banding procedures fared better than patients who watched their diets and exercised.
Results from “Bariatric Surgery versus Intensive Medical Therapy for Diabetes – 3-Year Outcomes,” which was funded by Johnson & Johnson (NYSE:JNJ) subsidiaries Ethicon and LifeScan, the Cleveland Clinic and the National Institutes of Health, were published online yesterday in the Journal of the American Medical Assn.
The 3-year, 61-patient study randomized obese subjects 1 of 3 arms: Ro...
Source: Mass Device - July 2, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Weight loss Journal of the American Medical Assn. (JAMA) Source Type: news
