Medtronic has obtained regulatory approval from the US Food and Drug Administration (FDA) to conduct an early feasibility study on its Native Outflow Tract transcatheter pulmonary valve (TPV), designed for the treatment of patients with ...
Tags: Medtronic, Native Outflow TPV, Medicine
Expanding Orthopedics, a spinal device company, Vin Germany for a clinical study of its XPED Expanding Pedicle Screw system. The system, which is commercially available in Europe, is designed to provide improved anchoring of the implant ...
Tags: Expanding Orthopedics, Clinical Study, Pedicle Screw System
PneumRx has treated the first US patient in a FDA-approved RENEW clinical study of its RePneu lung volume reduction coil (LVRC), designed to treat severe emphysema. Made from shape-memory Nitinol, the CE-marked minimally invasive medical ...
Tags: PneumRx, lung volume reduction coil, FDA
Covidien has completed patient enrollment in its VISIBILITY and DURABILITY Iliac stent clinical study series. The prospective, multinational, multicenter studies, which have enrolled 150 patients from 23 centers in the US and Europe, are ...
Ventrix said that its VentriGel biomaterial scaffold has shown potential to prevent heart failure following heart attack in a pre-clinical study. VentriGel is injected in a minimally-invasive procedure using a catheter to repair damaged ...
Tags: Ventrix, heart attack, minimally invasive
Galderma Laboratories has gained US marketing rights for its Epiduo (adapalene 0.1%/BPO 2.5%) Gel, designed for the treatment of acne in children as young as nine years old, following the approval from the US Food and Drug Administration ...
Neurim Pharmaceuticals has announced positive results from a phase II clinical study reviewing the efficacy and safety of piromelatine. The novel investigational multimodal sleep medicine has been developed for the treatment of patients ...
Tags: Neurim Pharmaceuticals, positive results, phase II clinical study
Absorbable surgical adhesives and sealants developer Cohera Medical has obtained $17m in Series D financing through private investors. The capital will be used by the company to expand adoption of its internal surgical adhesive in Germany ...
Tags: adhesives, sealants, surgical adhesive
Covidien has announced two-year clinical study results of its Solitaire FR revascularization device, designed for treating acute ischemic stroke. The FDA-approved and CE-marked mechanical thrombectomy device uses overlapping stent ...
Tags: clinical study, Covidien, FDA
Rockwell Medical has announced positive results from PRIME clinical study of iron-delivery drug, Soluble Ferric Pyrophosphate (SFP), demonstrating statistically significant 37% reduction in erythropoietin stimulating agents (ESA) dose. ...
Tags: Rockwell, iron delivery drug, Medical
Navidea Biopharmaceuticals has jouned forces with Maimonides Medical Centre to investigate Lymphoseek injections as a potential treatment for colorectal cancer. Dr. Danny Sherwinter, surgeon and the director of the Department of Minimally ...
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
Intersect ENT has started a blinded, multi-center, prospective, randomized clinical study, Resolve, of its new steroid delivery implant for treating patients with recurrent sinus obstruction. The implant, which is designed as an ...
Tags: Intersect ENT, clinical study, recurrent sinus obstruction
The European Union has granted CE mark to Covidien's EverFlex self-expanding peripheral stent for use with Entrust delivery system. Entrust system, which the company claims to be the only one-handed delivery device on the market, features ...
Laserwelt has entered into an agreement to distribute Verisante Technology's non-invasive optical system, designed for the evaluation of skin lesions that may be clinically suspicious for melanoma, squamous cell carcinoma and/or basal cell ...
Tags: Laserwelt, agreement, Verisante Technology, optical system