Staff Editor

19
Oct

AHWP WG5 Clinical Evaluation

AHWP WG5 Clinical Evaluation Clinical Evaluation Working Group 5, Clinical Performance & Safety 2015-11-03 Learn here about FDA training seminars

24
Nov

Ablation Catheter Approved to Treat Arrhythmia

FDA PMA Approval TactiCath Quartz Contact Force Ablation Catheter and TactiSys Quartz Equipment – P130026 FDA Approval Letter for P130026, Dated October 24, 2014 Summary of Safety and Effectiveness Data (SSED) and Labeling What is it? The TactiCath Quartz Contact Force Ablation Catheter (TactiCath) is a flexible catheter used to treat a certain kind of abnormal heart rhythm (arrhythmia) called paroxysmal

Read more

20
Nov

Common Moles Dysplastic Nevi and Risk of Melanoma

Moles, Dysplastic Nevi, and Risk of Melanoma Key Points A common mole (nevus) is a small growth on the skin that is usually pink, tan, or brown and has a distinct edge. People who have more than 50 common moles have a greater chance than others of developing a dangerous type of skin cancer known as melanoma. Most common moles

Read more

19
Nov

Report for Medication Therapy Management Interventions in Outpatient Settings

By Regulatory Doctor LinkedIn Google Plus Twitter Facebook Comparative Effectiveness Review Medication Therapy Management Interventions in Outpatient Settings This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products

Read more

13
Nov

FDA 510k Clearances October 2014

Summary of October 2014 510(k) Clearances TOTAL 510(k)s THIS PERIOD:                          264 TOTAL WITH 510(k) SUMMARIES:                254 TOTAL WITH 510(k) STATEMENTS:                10 510(k) Types Abbreviated 510(k)s:            8 Special 510(k)s:  

Read more