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Presentation TCT 2019

Best Practices in Animal Studies of Cardiovascular Devices: What Does the FDA Look For?

Presenter: Natalie Miller

September 28, 2019

Presentation TCT 2019

Best Practices in Biocompatibility Assessment of Cardiovascular Devices: What Does the FDA Look For?

Presenter: Claire Hambright

September 28, 2019

Presentation TCT 2019

The Winding Journey From EFS/FIH to Pivotal Study: How to Work Closely With the FDA Through the Ups and Downs

Presenter: Changfu Wu

September 28, 2019

Presentation TCT 2019

How to Get Your IDE Approved in the First Round: Tips and Common Mistakes to Avoid

Presenter: Jennifer Bastijanic

September 28, 2019

Presentation TCT 2019

Best Practices in Presubmissions: How to Make Them Useful for Everyone

Presenter: Ariel Ash-Shakoor

September 28, 2019

Presentation TCT 2019

It’s Now Official: The New CDRH Organizational Structure and How It May Impact Your Interactions With the FDA Through the Total Product Life Cycle

Presenter: Nicole Ibrahim

September 28, 2019

Presentation TCT 2019

Regulatory Considerations for New Valves and Adjunctive Devices

Presenter: Jennifer Bastijanic

September 27, 2019

Presentation TCT 2019

Transcatheter Mitral Valve Repair and Replacement Devices: Reimbursement Considerations

Presenter: Lori Ashby

September 27, 2019

Presentation TCT 2019

Transcatheter Mitral Valve Repair and Replacement Pivotal Trials: Regulatory Considerations

Presenter: Changfu Wu

September 27, 2019

Presentation TCT 2019

Transcatheter Mitral Valve Repair and Replacement Pivotal Trials: Industry Perspectives

Presenter: Ted Feldman

September 27, 2019

Presentation TCT 2019

Pivotal Transcatheter FMR Device Trials: Future Perspectives One Year After COAPT and MITRA-FR

Presenter: Gregg Stone

September 27, 2019

Presentation TCT 2019

Regulatory Considerations for High Bleeding Risk Patients Undergoing PCI

Presenter: Adrian Magee

September 27, 2019

Presentation TCT 2019

Reimbursement Pathways for Shock Devices

Presenter: Lori Ashby

September 27, 2019

Presentation TCT 2019

Designing Controlled Trials for Shock Devices: Population Targets and Safety and Effectiveness Considerations

Presenter: Anthony Gershlick

September 27, 2019

Presentation TCT 2019

Industry Perspectives on Controlled Trials for Shock Devices

Presenter: Seth Bilazarian

September 27, 2019

Presentation TCT 2019

Devices to Treat Shock: Regulatory Perspectives

Presenter: Fernando Aguel

September 27, 2019

Presentation TCT 2019

Perspectives on Infarct Size as a Surrogate in STEMI

Presenter: Navin Kapur

September 27, 2019

Presentation TCT 2019

Industry View on Controlled Trials for Heart Failure and Shock Devices

Presenter: William Abraham

September 27, 2019

Presentation TCT 2019

ARC Initiative for Heart Failure and Shock: HF ARC, Shock ARC, and More

Presenter: Christopher O'Connor

September 27, 2019

News Conference News TCT 2019

SCOPE I: Acurate Neo Comes Up Short for Severe Aortic Stenosis

Marcus A. Banks

September 27, 2019

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Best Practices in Animal Studies of Cardiovascular Devices: What Does the FDA Look For?

Best Practices in Biocompatibility Assessment of Cardiovascular Devices: What Does the FDA Look For?

The Winding Journey From EFS/FIH to Pivotal Study: How to Work Closely With the FDA Through the Ups and Downs

How to Get Your IDE Approved in the First Round: Tips and Common Mistakes to Avoid

Best Practices in Presubmissions: How to Make Them Useful for Everyone

It’s Now Official: The New CDRH Organizational Structure and How It May Impact Your Interactions With the FDA Through the Total Product Life Cycle

Regulatory Considerations for New Valves and Adjunctive Devices

Transcatheter Mitral Valve Repair and Replacement Devices: Reimbursement Considerations

Transcatheter Mitral Valve Repair and Replacement Pivotal Trials: Regulatory Considerations

Transcatheter Mitral Valve Repair and Replacement Pivotal Trials: Industry Perspectives

Pivotal Transcatheter FMR Device Trials: Future Perspectives One Year After COAPT and MITRA-FR

Regulatory Considerations for High Bleeding Risk Patients Undergoing PCI

Reimbursement Pathways for Shock Devices

Designing Controlled Trials for Shock Devices: Population Targets and Safety and Effectiveness Considerations

Industry Perspectives on Controlled Trials for Shock Devices

Devices to Treat Shock: Regulatory Perspectives

Perspectives on Infarct Size as a Surrogate in STEMI

Industry View on Controlled Trials for Heart Failure and Shock Devices

ARC Initiative for Heart Failure and Shock: HF ARC, Shock ARC, and More

SCOPE I: Acurate Neo Comes Up Short for Severe Aortic Stenosis

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