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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

Off-Hour Admission and Mortality Risk for 28 Specific Diseases: A Systematic Review and Meta-Analysis of 251 Cohorts Epidemiology
Conclusions Off-hour admission is associated with increased mortality risk, and the associations varied substantially for different diseases. Specialists, nurses, as well as hospital administrators and health policymakers can take these findings into consideration to improve the quality and continuity of medical services.
Source: JAHA:Journal of the American Heart Association - March 17, 2016 Category: Cardiology Authors: Zhou, Y., Li, W., Herath, C., Xia, J., Hu, B., Song, F., Cao, S., Lu, Z. Tags: Epidemiology, Risk Factors, Health Services, Meta Analysis, Mortality/Survival Source Type: research

Bringing WISDOM to Breast Cancer Care
Dr. Laura Esserman answers the door of her bright yellow Victorian home in San Francisco’s Ashbury neighborhood with a phone at her ear. She’s wrapping up one of several meetings that day with her research team at University of California, San Francisco, where she heads the Carol Franc Buck Breast Care Center. She motions me in and reseats herself at a makeshift home office desk in her living room, sandwiched between a grand piano and set of enormous windows overlooking her front yard’s flower garden. It’s her remote base of operations when she’s not seeing patients or operating at the hospita...
Source: TIME: Health - October 22, 2021 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized Source Type: news

New Analyses Suggest Favorable Results for STELARA ® (ustekinumab) When Used as a First-Line Therapy for Bio-Naïve Patients with Moderately to Severely Active Crohn’s Disease and Ulcerative Colitis
SPRING HOUSE, PENNSYLVANIA, October 25, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from two new analyses of STELARA® (ustekinumab) for the treatment of adults with moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC).1,2 In a modelled analysisa focused on treatment sequencing using data from randomized controlled trials, network meta-analysis and literature, results showed patient time spent in clinical remission or response was highest when STELARA was used as a first-line advanced therapy for bio-naïve patients with moderately to severely acti...
Source: Johnson and Johnson - October 25, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news