GlobalData on MSN2d
R3 Vascular secures investigational device exemption for PAD treatment
The company has announced that its new investigational device exemption will be used to launch a pivotal trial of its ...
MassDevice1d
R3 Vascular wins FDA IDE for drug-eluting scaffold
R3 Vascular announced today that the FDA granted investigational device exemption (IDE) to evaluate its drug-eluting ...
GlobalData on MSN2d
FDA grants clearance for study of Envoy Medical’s cochlear implant
US-based Envoy Medical has received approval from the US Food and Drug Administration (FDA) for its investigational device ...
Endovascular Today1d
Philips Begins Pivotal THOR Trial of Combined Device to Treat PAD
Royal Philips announced enrollment of the first patient in THOR, a United States investigational device exemption (IDE) clinica ...
MassDevice1d
FDA approves IDE for Akura Medical’s thrombectomy system
Akura Medical, a Shifamed portfolio company, announced today that the FDA granted its Katana system investigational device exemption (IDE).
TCTMD6d
ACURATE IDE Trial Misses Primary Endpoint in All-Risk TAVI Patients
The result calls into question the prospects of FDA approval for the Acurate neo2 valve, which is already in use globally.
Envoy Medical receives FDA approval to initiate study for hearing device
Envoy Medical (COCH) announces that its Investigational Device Exemption, IDE, application for its pivotal study of the Acclaim Fully Implanted ...
EurekAlert!9d
Impella ECP pivotal study demonstrates safety, efficacy for use in high-risk PCI
Results were presented at Transcatheter Cardiovascular Therapeutics (TCT) 2024 conference from the first completed pivotal ...
Endovascular Today11d
Jupiter Endovascular Commences Vertex System’s SPIRARE II US Pivotal Trial
Jupiter Endovascular, Inc. announced that the first patient has been treated in the SPIRARE II United States pivotal study of ...
Business Wire16d
Endospan Completes Enrollment of Primary Arm in NEXUS® Aortic Arch Stent Graft TRIOMPHE IDE Clinical Study
Endospan, a pioneer in endovascular solutions for the Aortic Arch, today announced the completion of enrollment for the primary arm of its TRIOMPHE In ...