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Presentation TCT 2019

Poly-Genetic Risk Analysis, Big Data Analytics, and Disease Prediction Models

Presenter: Robert Califf

September 26, 2019

Presentation TCT 2019

Session XI: Future Directions and Challenges in the MedTech Field - Featured Lecture: Clinical Validation of Emerging Technologies — In Which Direction Is the Global Landscape Changing?

Presenter: David Kong

September 26, 2019

Presentation TCT 2019

Keynote Lecture: FDA/CDRH — The Year in Review, Focus on CDRH’s Total Product Life Cycle Concept

Presenter: William Maisel

September 26, 2019

Presentation TCT 2019

Expectation for Utilizing Registry Data for Regulatory Use

Presenter: Sung-Hae Kim

September 26, 2019

Presentation TCT 2019

Expectation For Utilizing Registry Data For Regulatory Use – Industry’s View

Presenter: Kazuaki Sekiguchi

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

Introduction and Prospect of the HBD-for-Children Activities

Presenter: Nicole Ibrahim

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

TCT Shark Tank Innovation Competition Finalists - Early Feasibility of the Metavention Integrated Radio Frequency Nerve Ablation System to Improve Hyperglycemia and Fatty Liver in Type II Diabetic Subjects (Metavention)

Presentation TCT 2019

Early Feasibility of the Metavention Integrated Radio Frequency Nerve Ablation System to Improve Hyperglycemia and Fatty Liver in Type II Diabetic Subjects (Metavention)

Presenter: Felix Mahfoud

September 26, 2019

Presentation TCT 2019

Creating a Clear Path for Your Continous ECG Signals (SmartMedic)

Presenter: Adrian Maciejewski

September 26, 2019

Presentation TCT 2019

Sweden View

Presenter: David Erlinge

September 26, 2019

Presentation TCT 2019

Japan View

Presenter: Tetsuya Amano, MD

September 26, 2019

Presentation TCT 2019

USA View

Presenter: David Kong

September 26, 2019

Presentation TCT 2019

Japanese Regulatory Efforts to Promote and Accept Real-World Evidence

Presenter: Hanako Morikawa

September 26, 2019

Presentation TCT 2019

Real-World Evidence in Japan: Practical Considerations for Data Collection and Use

Presenter: Masahiko Fujihara

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

Jon DeHaan Foundation Award for Interventional Innovation

Presenter: Robert Schwartz

September 26, 2019

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Poly-Genetic Risk Analysis, Big Data Analytics, and Disease Prediction Models

Session XI: Future Directions and Challenges in the MedTech Field - Featured Lecture: Clinical Validation of Emerging Technologies — In Which Direction Is the Global Landscape Changing?

Keynote Lecture: FDA/CDRH — The Year in Review, Focus on CDRH’s Total Product Life Cycle Concept

Expectation for Utilizing Registry Data for Regulatory Use

Expectation For Utilizing Registry Data For Regulatory Use – Industry’s View

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

Introduction and Prospect of the HBD-for-Children Activities

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

Early Feasibility of the Metavention Integrated Radio Frequency Nerve Ablation System to Improve Hyperglycemia and Fatty Liver in Type II Diabetic Subjects (Metavention)

Creating a Clear Path for Your Continous ECG Signals (SmartMedic)

Sweden View

Japan View

USA View

Japanese Regulatory Efforts to Promote and Accept Real-World Evidence

Real-World Evidence in Japan: Practical Considerations for Data Collection and Use

New Horizons for Innovation: Japanese Regulatory Initiatives

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

Jon DeHaan Foundation Award for Interventional Innovation

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