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Presentation TCT 2019

After the Champagne for PMA Approval Come Your Obligations: Inspections, Postapproval Studies, Medical Device Reporting, and Recalls

Presenter: Megha Reddy

September 28, 2019

News Conference News TCT 2019

LEVANT: Patient-Level Data Show No Increase in 5-Year Death for Paclitaxel DCBs in PAD

L.A. McKeown

September 28, 2019

Presentation TCT 2019

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

Presenter: Hiren Mistry

September 28, 2019

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

News Conference News TCT 2019

‘Spooky’ Signal Still Haunts Paclitaxel DCBs in PAD, but Updated Analysis Reassures

L.A. McKeown

September 28, 2019

Presentation TCT 2019

The US EFS and Breakthrough Devices Programs: An FDA Update

Presenter: Andrew Farb

September 26, 2019

Session XI: Future Directions and Challenges in the MedTech Field - Featured Technology: Miniaturization of Medical Devices Through High-Definition Manufacturing — A Precision Micro-Device Ablation Technology

Presentation TCT 2019

Featured Technology: Miniaturization of Medical Devices Through High-Definition Manufacturing — A Precision Micro-Device Ablation Technology

Presenter: Christian Palmaz

September 26, 2019

Session XI: Future Directions and Challenges in the MedTech Field - Smart Medical Devices: Technological Trends That Will Revolutionize the Medical Field

Presentation TCT 2019

Smart Medical Devices: Technological Trends That Will Revolutionize the Medical Field

Presenter: Marvin Slepian

September 26, 2019

Presentation TCT 2019

Current Approach to Promote Development of Pediatric Medical Devices in the US and Japan

Presenter: Sara Takahashi

September 26, 2019

Presentation TCT 2019

Safety of PTX Devices for PAD in Japan: Academic View

Presenter: Masato Nakamura

September 26, 2019

Presentation TCT 2019

Statistical Considerations: Competing Risk, Pooling Data, RCT vs. Observational Data

Presenter: Roseann White

September 26, 2019

Presentation TCT 2019

Moving From “Signal Detection” to “Signal Discernment”: An FDA View

Presenter: Eleni Whatley

September 26, 2019

Presentation TCT 2019

New Horizons for Innovation: Japanese Regulatory Initiatives

Presenter: Fumihito Takanashi

September 26, 2019

Presentation TCT 2019

Introduction to HBD and US-Japanese Collaborations Past, Present, Future

Presenter: Mitchell Krucoff

September 26, 2019

Presentation TCT 2019

Closing Remarks

Presenter: Nabil Dib

September 25, 2019

News Conference News TCT 2019

Robotics and Augmented Reality Show Promise for Improving Access to Care, Reducing Patient Anxiety

L.A. McKeown

September 25, 2019

Presentation TCT 2019

FDA Perspectives

Presenter: Lydia Glaw

September 25, 2019

Presentation TCT 2019

Non-Clinical Evaluation

Presenter: Kevin Croce

September 25, 2019

Presentation TCT 2019

Unmet Clinical Needs/Current and Future Direction

Presenter: Ajay Kirtane

September 25, 2019

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After the Champagne for PMA Approval Come Your Obligations: Inspections, Postapproval Studies, Medical Device Reporting, and Recalls

LEVANT: Patient-Level Data Show No Increase in 5-Year Death for Paclitaxel DCBs in PAD

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

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?

‘Spooky’ Signal Still Haunts Paclitaxel DCBs in PAD, but Updated Analysis Reassures

The US EFS and Breakthrough Devices Programs: An FDA Update

Featured Technology: Miniaturization of Medical Devices Through High-Definition Manufacturing — A Precision Micro-Device Ablation Technology

Smart Medical Devices: Technological Trends That Will Revolutionize the Medical Field

Current Approach to Promote Development of Pediatric Medical Devices in the US and Japan

Safety of PTX Devices for PAD in Japan: Academic View

Statistical Considerations: Competing Risk, Pooling Data, RCT vs. Observational Data

Moving From “Signal Detection” to “Signal Discernment”: An FDA View

New Horizons for Innovation: Japanese Regulatory Initiatives

Introduction to HBD and US-Japanese Collaborations Past, Present, Future

Closing Remarks

Robotics and Augmented Reality Show Promise for Improving Access to Care, Reducing Patient Anxiety

FDA Perspectives

Non-Clinical Evaluation

Unmet Clinical Needs/Current and Future Direction

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