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 ...
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 ...
MassDevice22h
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 ...
MassDevice23h
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 ...
Endovascular Today2d
Study Finds Mortality and Rupture Are Uncommon After Elective FB-EVAR of Asymptomatic, Intact Thoracoabdominal Aortic Aneurysms
In a multicenter, prospective, nonrandomized study evaluating outcomes of fenestrated-branched endovascular aortic repair (FB ...
Becker's Spine Review2d
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 ...
Becker's Spine Review1d
5 medtech notes: Smith+Nephew, Zavation and more
From a company layoff to FDA nods, here are five key developments from spine and orthopedic medtech companies since Dec. 4.
GlobalData on MSN2d
SetPoint’s neurostimulation device for rheumatoid arthritis ready for FDA review
SetPoint Medical’s vagus nerve stimulator offers another treatment option for patients who do not properly respond to ...
pharmaphorum2d
Regulatory timelines in the Asia-Pacific
A CTIL is needed for an imported Investigational Product (IP) and a Clinical Trials Exemption (CTX ... The Pharmaceuticals and Medical Device Agency (PMDA) offers consultation before clinical ...
Artivion: FDA grants HDE for use of AMDS Hybrid Prosthesis
Artivion (AORT) announced that the U.S. FDA has granted a Humanitarian Device Exemption for use of the AMDS Hybrid Prosthesis in acute DeBakey ...