Medtech Matters

153 Episodes

1. AI Predetermined Change Control Plan

   Published: 9/19/2023
2. Can You Use a Recalled Device as a Predicate?

   Published: 6/20/2023
3. Leading Issues from FDA Inspections (or History Repeating Itself)

   Published: 4/4/2023
4. To Regulate or Not to Regulate…LDTs, Part 2

   Published: 2/7/2023
5. To Regulate or Not to Regulate…Lab Developed Tests, Part 1

   Published: 1/31/2023
6. What Happens When the EUA Period Ends?

   Published: 12/13/2022
7. What Does 510k Exempt Actually Mean?

   Published: 11/29/2022
8. How Can Off-Label Use Be Promoted?

   Published: 11/15/2022
9. FDA's Intended Use Rule’s Relation to Labeling

   Published: 11/1/2022
10. Gaining an Advantage Through Class II Special Controls

    Published: 10/25/2022
11. FDA’s Refuse to Accept Policy for 510(k)s

    Published: 10/18/2022
12. Initiating a Voluntary Medical Device Recall

    Published: 10/11/2022
13. A Letter to File Deep Dive

    Published: 10/4/2022
14. Discussion of Neuromodulation Technology with Medtronic's Dave Anderson

    Published: 5/31/2022
15. Humacyte’s Bioengineered Tissue Platform Technology

    Published: 3/8/2022
16. Koya Medical Restores Mobility for Compression Therapy Patients

    Published: 3/1/2022
17. NeuroPace’s Aid in Tracking and Treating Epilepsy

    Published: 2/22/2022
18. Aidoc Is Improving Patient Outcomes Through AI

    Published: 2/15/2022
19. Performing a Gap Analysis on FDA's Regulatory Protocols

    Published: 2/8/2022
20. Stereotaxis’ Robotic Surgery System for Interventional Procedures

    Published: 2/1/2022