GlobalData on MSN1d
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 MSN1d
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 ...
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.
GlobalData on MSN1d
FDA grants approval to commence trial of R3 Vascular’s scaffold
The trial is anticipated to commence in Q1 2025 and will enrol 264 subjects at up to 60 clinical sites worldwide.
Envoy Medical Receives FDA Approval To Initiate Pivotal Clinical Study for Breakthrough Hearing Device
The Acclaim® Fully ImplantedCochlear Implant is differentiated from existing cochlear implants and may offer new option for hearing loss patients ...
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 ...
TCTMD8d
FDA Approves Dual-Energy System for AF Ablation
The Affera mapping and ablation system is the first on the market that can deliver both pulsed-field and radiofrequency ...
Becker's Spine Review7d
CytexOrtho earns FDA approval for absorbable hip implant trials
CytexOrtho has earned FDA approval to begin a clinical trial evaluating the safety and efficacy of its absorbable hip implant in human patients, according to an Oct. 29 report from Mass Device. The ...