Metavention's Renal Denervation Pivotal IDE Study now Approved by FDA for the Treatment of Hypertension
Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA | Trials | Full Text
FDA Approval of IDE to Initiate Multi-Center Pivotal Study of Alpha DaRT™ in Recurrent Cutaneous SCC
Nearly 20% of therapeutic devices cleared without pivotal clinical study
Attachment E CDRH Final Guidance Cover Sheet
FDA approval of drugs and transparency in clinical trial results | Science-Based Medicine
FDA 101: A Primer on IDEs - Clinical and Translational Science Institute - University at Buffalo
Early feasibility studies in the United States: Focus on electrophysiology - Weiss - 2023 - Journal of Cardiovascular Electrophysiology - Wiley Online Library
Clinical Trial Phases | Power
Mainz Biomed Announce IRB Approval and Initiation of US Pivotal FDA Clinical Study | Technology Networks
With results of pivotal study, AppliedVR to seek FDA clearance - MedCity News
Real-Time Oncology Review | FDA
Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA | Trials | Full Text
Characteristics of Pivotal Trials and FDA Review of Innovative Devices | PLOS ONE
Ongoing and Upcoming Studies
Early phase clinical trial played a critical role in the Food and Drug Administration–approved indications for targeted anticancer drugs: a cross-sectional study from 2012 to 2021 - ScienceDirect
Jim Yearick on LinkedIn: Endotronix Announces FDA Approval for PROACTIVE-HF Pivotal Trial Design…
PQ Bypass Announces Unconditional IDE Approval from U.S. FDA for Pivotal Study. - Seroba Life Sciences
FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Non-Comparative Clinical Outcome Studies | RegDesk
Joachim Eeckhout on LinkedIn: #crispr #biotech
Early Feasibility Studies for Cardiovascular Devices in the United States: JACC State-of-the-Art Review - ScienceDirect
Sample construction for pivotal trials using surrogate markers with... | Download Scientific Diagram
The Winding Journey From EFS/FIH to Pivotal Study: How to Work Closely With the FDA Through the Ups and Downs | tctmd.com
Early Feasibility Studies for Cardiovascular Devices in the United States: JACC State-of-the-Art Review - ScienceDirect
Summary of pivotal study designs for evaluating the efficacy of human... | Download Table
FDA Approves RECOVER IV Randomized Controlled Trial with Exception from Informed Consent (EFIC) | DAIC
