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Labeling Considerations for Devices With Lubricious Coatings Addressed in FDA Draft Guidance

June 20, 2018 -- The US Food and Drug Administration (FDA) has issued a draft guidance document on labeling considerations for devices containing lubricious coatings…

FDA Issues Draft Guidance on Performance Tests and Labeling for Guidewires

June 20, 2018 -- The US Food and Drug Administration (FDA) has issued a draft guidance document that provides draft recommendations for 510(k) submissions for guidewires inten…

FDA Seeks to Strengthen Public Warnings and Recall Notifications; CDRH Outlines Strategic Priorities

January 18, 2018 -- US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, issued a statement on the agency's new policy steps for strengthening public war…

Magenta Medical Secures Funding for Development of Therapies for Acute Heart Failure

September 28, 2017 -- Magenta Medical, an Israel-based company developing therapeutic approaches to the management and treatment of acute heart failure, announced the closing …

Medtronic's Micra Pacing System Receives CMS Coverage

March 10, 2017 -- Medtronic announced that the US Centers for Medicare & Medicaid Services (CMS) have approved coverage for the company's Micra transcatheter pacing sy…

Boston Scientific Voluntarily Recalls All Lotus TAVR Devices

February 23, 2017 -- In a Form 8-K report to the US Securities and Exchange Commission (SEC), Boston Scientific announced a voluntary removal of all Lotus transcathe…

Abbott Set to Close Acquisition of St. Jude Medical, Inc.

January 3, 2017 -- Abbott Vascular announced last week that it intends to close the acquisition of St. Jude Medical, Inc. on Wednesday, January 4. The announcement follows the…

 

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2019 Buyer’s Guide

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

 

Top 5 Top 5 In Regulatory Center

FDA Seeks to Strengthen Public Warnings and Recall Notifications; CDRH Outlines Strategic Priorities

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

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

SCAI Comments on CMS MEDCAC Panel Regarding TAVR

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

 

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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.