GlobalData on MSN1d
FemPulse wins FDA IDE to use overactive bladder vaginal ring in pivotal trial
FemPulse’s CEO Alexandra Haessler said the FemPulse Ring was designed as an “internal wearable” with a “set it and forget it” ...
Hosted on MSN1d
EndoQuest wins FDA IDE to commence robot trial in colorectal indication
EndoQuest plans to test its technology on an estimated 50 participants enrolled across five sites in the US. The company’s ...
US FDA Grants Investigational Device Exemption (IDE) to EndoQuest™ Robotics for Its Flexible Robotic System
EndoQuest will commence its PARADIGM clinical trial for endoluminal robotic colorectal surgery at five leading US hospitals ...
MassDevice1d
FemPulse wins FDA IDE for for overactive bladder neuromod
FemPulse announced today that it received FDA investigational device exemption (IDE) approval for its overactive bladder (OAB ...
FemPulse Receives FDA IDE Approval for the Pivotal Clinical Trial of its Wearable Bioelectronic Device for Overactive Bladder in Women
FemPulse™ announced today Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin its EVANESCE II pivotal clinical trial in female patients suffering ...
MassDevice1d
EndoQuest wins FDA IDE to study surgical robot in colorectal surgery
EndoQuest Robotics announced today that it received FDA investigational device exemption (IDE) for a study of its surgical ...
Endovascular Today1d
RapidPulse Receives IDE Approval for Pivotal Study of Its Cyclic Aspiration System for Ischemic Stroke
RapidPulse, Inc. announced FDA approval of an investigational device exemption (IDE) for the company to study the RapidPulse c ...
Endoquest robotic system gets FDA OK to launch clinical trial
In January, Endoquest’s system was accepted into the FDA’s Safer Technologies Program for devices expected to improve the safety of available treatment options. Participants in the program benefit ...
Endovascular Today3d
Artivion Granted FDA Humanitarian Device Exemption for AMDS Hybrid Prosthesis
Artivion, Inc. announced that the FDA has granted a humanitarian device exemption (HDE) for use of the of the AMDS hybrid ...
Becker's Spine Review3d
Theradaptive earns additional FDA OK for OsteoAdapt spine study
Theradaptive earned the FDA's investigational device exemption approval to broaden its clinical research for the OsteoAdapt SP implant, the company said Dec. 10 ...