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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
Importance of Exercise Capacity in Predicting Outcomes and Determining Optimal Timing of Surgery in Significant Primary Mitral Regurgitation Valvular Heart Disease
Conclusion
In patients with primary MR that underwent exercise echocardiography followed by MV surgery, lower achieved metabolic equivalents were associated with worse long-term outcomes. In those with preserved exercise capacity, delaying MV surgery by ≥1 year did not adversely affect outcomes.
Source: JAHA:Journal of the American Heart Association - September 11, 2014 Category: Cardiology Authors: Naji, P., Griffin, B. P., Barr, T., Asfahan, F., Gillinov, A. M., Grimm, R. A., Rodriguez, L. L., Mihaljevic, T., Stewart, W. J., Desai, M. Y. Tags: Valvular Heart Disease Source Type: research
Predictors of Long-Term Outcomes in Patients with Significant Myxomatous Mitral Regurgitation Undergoing Exercise Echocardiography.
CONCLUSIONS: In patients with ≥III+ myxomatous MR undergoing ExEc, lower %age-gender predicted METS, lower HRR, atrial fibrillation, lower LV ejection fraction and high resting RVSP predicted worse outcomes.
PMID: 24396041 [PubMed - as supplied by publisher]
Source: Circulation - January 6, 2014 Category: Cardiology Authors: Naji P, Griffin BP, Asfahan F, Barr TS, Rodriguez LL, Grimm R, Agarwal S, Stewart WJ, Mihaljevic T, Gillinov AM, Desai MY Tags: Circulation Source Type: research
