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Separating Regulatory and Clinical Standards

Gary M. Ansel, MD; and Raghu Kolluri, MD, RVT, RPVI

September/October 2018—Understanding the FDA device approval process and the difference between data from premarket and postapproval trials to make informed clinical decisions.

Challenging Cases: What Would You Do?

Ted E. Feldman, MD, MSCAI, FACC, FESC; and Shakeel A. Qureshi, MD, FRCP, FRCPCH

September/October 2018— Most issues of Cardiac Interventions Today are focused on a single disease state. This issue takes a different approac

Cook Medical Resolves 2014 FDA Warning Letter

September 11, 2018 -- Cook Medical announced it has received a close-out notification from the US Food and Drug Administration, resolving the warning letter issued to the comp…

SCAI Comments on CMS MEDCAC Panel Regarding TAVR

July 26, 2018 -- The Society for Cardiovascular Angiography and Interventions (SCAI) released a statement commenting on the meeting of the Centers for Medicare & Medicaid …

Edwards Responds to MEDCAC Panel Meeting on Procedural Volume Requirements for TAVR

July 26, 2018 -- Edwards Lifesciences commented on the US Centers for Medicare & Medicaid Services’ (CMS) advisory panel regarding evidence pertaining to proced…

CMS to Convene MEDCAC Panel to Consider Procedural Volume Requirements for TAVR

July 2, 2018 -- The Centers for Medicare & Medicaid Services (CMS) will convene a panel of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) on Ju…

Labeling Considerations for Devices With Lubricious Coatings Addressed in FDA Draft Guidance

June 20, 2018 -- The US Food and Drug Administration (FDA) has issued a draft guidance document on labeling considerations for devices containing lubricious coatings…

FDA Issues Draft Guidance on Performance Tests and Labeling for Guidewires

June 20, 2018 -- The US Food and Drug Administration (FDA) has issued a draft guidance document that provides draft recommendations for 510(k) submissions for guidewires inten…

 

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2018 Buyer’s Guide

This Buyer’s Guide offers a searchable, comprehensive listing of the FDA-approved interventional devices available in the United States.

 
 

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484-581-1816
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Charles Philip
484-581-1873
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About Cardiac Interventions Today

Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing comprehensive coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. Cardiac Interventions Today premiered in March 2007 and each edition contains a variety of topics in a flexible format, including articles covering various perspectives on current clinical topics, in-depth interviews with expert physicians, overviews of available technologies, industry news, and insights into the issues affecting today's interventional cardiology practices.