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Presentation TCT 2018

FDA Perspectives on Sham-Controlled Trials

Presenter: Kenneth J. Cavanaugh Jr, Roxana Mehran, Hiren Mistry

September 23, 2018

Presentation TCT 2018

Sham Controls in Renal Denervation Studies: Need to Have vs Nice to Have?

Presenter: Kenneth J. Cavanaugh Jr, Roxana Mehran, David E. Kandzari

September 23, 2018

Presentation TCT 2018

ORBITA One Year Later: What Would I Do Differently, If Anything?

Presenter: Kenneth J. Cavanaugh Jr, Roxana Mehran, Rasha Al-Lamee

September 23, 2018

Presentation TCT 2018

Point to Consider in the Review of the RDN Related Devices: US Regulatory

Presenter: Kenneth J. Cavanaugh Jr, Takafumi Ueno, Hiren Mistry

September 22, 2018

Presentation TCT 2018

FDAs Patient Engagement Initiatives: How FDA Can Incorporate Patient Centered and Patient Reported Outcomes in Regulatory Decision-Making

Presenter: John C Laschinger

September 22, 2018

Presentation TCT 2018

Point to Consider in the Review of the LAAC Related Devices: Japanese Regulatory View: PMDA

Presenter: Akihide Konishi

September 22, 2018

Presentation TCT 2018

Point Parity Should Include Valve Assessments, Regulatory Standards, and Equal Patient Access

Presenter: Michael J. Mack

September 22, 2018

Presentation TCT 2018

How We Can Utilize the RWE for Regulatory Decision Making? FDA Perspective

Presenter: Neal Fearnot, John C Laschinger

September 22, 2018

Presentation TCT 2018

Early Feasibility Studies for Device Evaluation

Presenter: Spencer B. King III, Bram D. Zuckerman, Andrew Farb

September 21, 2018

Presentation TCT 2018

Pre-Clinical and Clinical Trial Design and Endpoints for Device Approval

Presenter: Spencer B. King III, Bram D. Zuckerman, Chris Mullin, Roseann M White

September 21, 2018

Presentation TCT 2018

Practice Guideline Requirement for New Technology

Presenter: Spencer B. King III, Bram D. Zuckerman, Alice K. Jacobs

September 21, 2018

Presentation TCT 2018

CMS Requirement for Reimbursement for Innovation

Presenter: Spencer B. King III, Bram D. Zuckerman, Lori M Ashby

September 21, 2018

Presentation TCT 2018

Regulatory Requirement for Marketing Approval including the Parallel Review, NEST, and Beyond

Presenter: Spencer B. King III, Bram D. Zuckerman

September 21, 2018

News Daily News

Lack of Short-term Cancer Risk With Tainted Valsartan ‘Reassuring’

Todd Neale

September 13, 2018

News Conference News ESC 2018

Myocardial Injury or MI? New Universal Definition Aims for Clarity

Todd Neale

September 05, 2018

News Daily News

‘The Bleeding Edge’ Documentary, Tackling Medical Device Regulation, Spurs Diverse Cardiology Reactions

Yael L. Maxwell

August 17, 2018

News Daily News

‘We Have to Go to Them’: New Global Initiative for Treating Rheumatic Heart Disease

Michael O'Riordan

August 06, 2018

News Daily News

No Benefits, Higher Costs With IVC Filters in Catheter-Directed Thrombolysis for DVT

Michael O'Riordan

July 23, 2018

News Daily News

High-Risk Medical Device Approval Process in Europe Inches Towards Transparency

Michael O'Riordan

July 20, 2018

News Daily News

Rivaroxaban Offers Net Reduction in Fatal or Irreversible Events in ACS: ATLAS ACS-2 TIMI-51

Michael O'Riordan

July 06, 2018

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FDA Perspectives on Sham-Controlled Trials

Sham Controls in Renal Denervation Studies: Need to Have vs Nice to Have?

ORBITA One Year Later: What Would I Do Differently, If Anything?

Point to Consider in the Review of the RDN Related Devices: US Regulatory

FDAs Patient Engagement Initiatives: How FDA Can Incorporate Patient Centered and Patient Reported Outcomes in Regulatory Decision-Making

Point to Consider in the Review of the LAAC Related Devices: Japanese Regulatory View: PMDA

Point Parity Should Include Valve Assessments, Regulatory Standards, and Equal Patient Access

How We Can Utilize the RWE for Regulatory Decision Making? FDA Perspective

Early Feasibility Studies for Device Evaluation

Pre-Clinical and Clinical Trial Design and Endpoints for Device Approval

Practice Guideline Requirement for New Technology

CMS Requirement for Reimbursement for Innovation

Regulatory Requirement for Marketing Approval including the Parallel Review, NEST, and Beyond

Lack of Short-term Cancer Risk With Tainted Valsartan ‘Reassuring’

Myocardial Injury or MI? New Universal Definition Aims for Clarity

‘The Bleeding Edge’ Documentary, Tackling Medical Device Regulation, Spurs Diverse Cardiology Reactions

‘We Have to Go to Them’: New Global Initiative for Treating Rheumatic Heart Disease

No Benefits, Higher Costs With IVC Filters in Catheter-Directed Thrombolysis for DVT

High-Risk Medical Device Approval Process in Europe Inches Towards Transparency

Rivaroxaban Offers Net Reduction in Fatal or Irreversible Events in ACS: ATLAS ACS-2 TIMI-51

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