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CMS Proposes Updates to Coverage Policy for TAVR

April 1, 2019 -- The Centers for Medicare & Medicaid Services (CMS) proposed to update its national coverage policy for transcatheter aortic valve replacement (TAVR). CMS …

FDA Updates Process for Issuing Public Warnings and Notifications of Recalls

February 7, 2019 -- FDA Commissioner Scott Gottlieb, MD, announced new steps that the agency is taking to strengthen and modernize its process for issuing a public warning abo…

FDA Proposes Procedures and Criteria for De Novo Pathway for Medical Devices

December 5, 2018 -- The FDA announced it has published the De Novo Classification Proposed Rule. If finalized, the rule will establish procedures and criteria for the De Novo …

FDA Announces Plans to Modernize 510(k) Program

November 26, 2018 -- FDA Commissioner Scott Gottlieb, MD, and Jeff Shuren, MD, Director of the FDA's Center for Devices and Radiological Health (CDRH), announced proposed …

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 …

 

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US Device Guide

The Cardiac Interventions Today Europe Device Guide offers a searchable, comprehensive listing of the available interventional cardiology devices in the United States.

 
 

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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.