NeuroSigma has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to begin a Phase III pivotal trial of its Monarch eTNS System. Designed to treat the drug resistant epilepsy, the ...
Tags: Device Trial, NeuroSigma
St. Jude Medical has implanted the first patient in a clinical study of its Amplatzer Cardiac Plug (ACP) device, designed for the prevention of stroke in patients with non-valvular atrial fibrillation (AF). The self-expanding occlusion ...
Tags: St.Jude Medical, clinical study, ACP device
Velomedix has completed enrollment of the first patient in Velocity clinical study of its rapid therapeutic hypothermia system for treating acute myocardial infarction (AMIs or heart attacks). Using a peritoneal-based approach, the ...
Tags: Velomedix, Velocity clinical study, rapid therapeutic hypothermia system
Medtronic has commenced prospective, open-label, parallel-group PROMISE trial of its neurostimulation therapy device for treating patients with chronic low back pain associated with failed back surgery syndrome (FBSS). The spinal cord ...
ElectroCore has initiated enrolling patients in a clinical trial of its GammaCore nVNS therapy, designed for preventing chronic migraine. The easy-to-use, non-invasive device, which enables self-administration of therapy, stimulates ...
Medtronic has completed enrolling the first patient in MIRACLE EF clinical trial, designed to evaluate the effectiveness of its Consulta cardiac resynchronization therapy-pacemaker (CRT-P) in treating symptomatic heart failure patients with ...
Tags: Medtronic, MIRACLE EF, trial, CRT-P
CellAegis Devices has obtained Health Canada's investigational testing (ITA) approval to initiate a pilot clinical trial of its noninvasive autoRIC device for remote ischemic conditioning (RIC). The CE-marked device is placed around ...
Tags: Health Canada, ITA, clinical trial, RIC
SciBase has announced positive results of its non-invasive point-of-care Nevisense device from the pivotal SIMPS study. The patented Nevisense device, which includes an electrode on a hand-held probe, utilizes electrical impedance ...
Tags: SciBase, Nevisense device, electrical impedance spectroscopy
Micro Interventional Devices has initiated first-in-man Sutureless Transapical Access and Closure study (STASIS) trial to demonstrate the efficacy of its transapical access device in providing hemostatic access to the left ventricle during ...
Tags: Micro Interventional Devices, man Sutureless, cardiac procedures
Avita Medical has initiated an European clinical study of its ReCell Spray-On Skin device, designed for treating venous leg ulcers. Designed for use in burns, plastic, reconstructive and cosmetic procedures, the device uses the company's ...