Food and Drug Administration for its Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter, which is currently the subject of an Investigational Device Exemption
study called DISRUPT CAD III.
Medical technology company Endotronix Inc reported on Thursday the receipt of conditional Investigational Device Exemption
(IDE) approval from the US Food and Drug Administration (FDA) to commence the multi-centre PROACTIVE-HF trial of the Cordella Pulmonary Artery (PA) Pressure Sensor System (Cordella Sensor) in chronic heart failure patients.
Global Banking News-June 25, 2019-Micro Medical Solutions awarded FDA Investigational Device Exemption
(IDE) approval to evaluate MicroStent for CLI and PAD
The company will file an investigational device exemption
(IDE) supplement to add an interim efficacy readout in the fourth quarter of 2018 and expects top line data in the fourth quarter of 2019.
It has been granted an Investigational Device Exemption
(IDE) to initiate a pivotal human clinical study of the system in the United States.
Food and Drug Administration for an Investigational Device Exemption
In the United States, XEN45 is in late-stage development, with the final US Investigational Device Exemption
clinical trial fully enrolled in the second quarter of 2015.
After it secures approval for its investigational device exemption
application, Senseonics expects to begin clinical trials in the United States next year.
HeartWare's pre-market approval (PMA) submission included data from the Company's pivotal ADVANCE clinical trial, an FDA approved Investigational Device Exemption
(IDE) study designed to evaluate the system as a bridge to heart transplants with end-stage heart failure.
Brainsway's (TASE:BRIN) periodic report for 2010, has received an Investigational Device Exemption
("IDE") approval from the U.S.
The FDA has given approval for an investigational device exemption
(IDE) feasibility study to be conducted at both Wake Forest Baptist and University of California, San Francisco (UCSF).