Medtech Matters

153 Episodes

1. Benefit-Risk Determinations

   Published: 9/16/2019
2. Mike on Medtech: Beyond 510(k)/PMA—Breakthrough Devices Program

   Published: 8/6/2019
3. Beyond 510(k)/PMA—De Novo 101

   Published: 7/2/2019
4. Mike on Medtech: The NYT Editorial Board Statement

   Published: 6/17/2019
5. The Alternative Summary Reporting Program

   Published: 5/24/2019
6. Do we need a pre-sub for 483s? (Part 2)

   Published: 5/9/2019
7. Do we need a pre-sub for 483s?

   Published: 5/9/2019
8. FDA's Material Evaluation

   Published: 4/2/2019
9. 510k Modernization

   Published: 1/25/2019
10. Personalized Healthcare

    Published: 1/3/2019
11. My Holiday Wish List (Part 2)

    Published: 12/11/2018
12. My Holiday Wish List (Part 1)

    Published: 12/4/2018
13. Regulating the Practice of Medicine

    Published: 10/26/2018
14. The Bleeding Edge, Part 3

    Published: 9/26/2018
15. The Bleeding Edge, Part 2

    Published: 9/7/2018
16. The Bleeding Edge, Part 1

    Published: 9/5/2018
17. Breakthrough Designation Program

    Published: 8/10/2018
18. 15 Tips for Getting New Products Through FDA

    Published: 7/3/2018
19. Voice-Enabled Medtech

    Published: 5/17/2018
20. Changing Pathway to Market?

    Published: 4/25/2018