CardioLogical Solutions, a cardiovascular device company, has reported successful in vivo validation of its VasoStitch device, designed to make transcatheter aortic valve implantation (TAVI) procedures percutaneous and safer. The ...
PolyNovo Biomaterials, a wholly-owned subsidiary of Calzanda, has filed 510(k) application with the US Food and Drug Administration (FDA) for an approval to market its NovoSorb wound dressing in topical negative pressure (TNP) wound ...
Tissue repair company Regentis Biomaterials has reported positive results from a clinical safety study of hydrogel implant GelrinC, designed to treat articular cartilage in injured knees. The CE mark-approved GelrinC hydrogel implant is ...
Tags: Regentis Biomaterials, Medicine
Avinger, a manufacturer of multifunctional catheters, has received CE Mark approval for Pantheris, a lumectomy catheter designed to remove the blockage while avoiding the disruption of normal arterial wall structures. This lumivascular ...
HeartWare International has received the U.S. Food and Drug Administration (FDA) approval to enroll supplemental patient cohort for ENDURANCE, a pivotal destination therapy clinical study. HeartWare will enroll up to 286 patients ...
PFM Medical, a developer and manufacturer of minimally invasive medical devices for cardio vascular technology, vascular access, surgery, and oncology, has received the US Food and Drug Administration (FDA) premarket approval for its ...
Tags: PFM Medical, Medicine
Kinetic Concepts has launched its new V.A.C. VeraFlo large dressing for larger wounds and wounds requiring additional c. VeraFlo large dressing is designed for easy application of V.A.C. VeraFlo instillation therapy. With this ...
Tags: Kinetic, Dressing Product
Cerevast Therapeutics has initiated patient enrollment in the Phase III clinical trial to evaluate the use of its Clotbust ER ultrasonic headframe for the treatment of acute ischemic stroke. The Clotbust ER Phase III clinical study is ...
Tags: Cerevast Therapeutics
US-based BioFire Diagnostics has begun clinical and analytical studies to evaluate its FilmArray Gastrointestinal (GI) Panel. This clinical study is being conducted at several hospital-based clinical laboratories in the US and is funded ...
InSightec has received approval from the Chinese Food and Drug Administration (CFDA) for its ExAblate system designed to treat uterine fibroids non-invasively. This system uses high intensity focused ultrasound energy to destroy the ...
Tags: InSightec, Ultrasound System
La Jolla Pharmaceutical Company has reported a comprehensive net loss attributable to common stockholders of $3.74m, or $0.14 per share, for the second quarter ended on 30 June 2013 compared with $7.77m, or $0.67 per share in 2012. ...
Tags: La Jolla Pharmaceutical, Net Loss
LifeCodexx has revealed that its PrenaTest, a non-invasive molecular genetic blood test, can now be performed to determine high risk pregnancies even as early as the ninth week of pregnancy. Generally, PrenaTest is used to determine fetal ...
Tags: LifeCodexx, Pregnancy, Medicine
BD Medical, a division of Becton, Dickinson and Company, has launched the BD Ultra-Fine Nano 4mm Pen Needle with EasyFlow Technology in US. Making the procedure fast and easy, EasyFlow Technology helps patients in injecting insulin each ...
Tags: Health, Medicine, Medical's Pen Needle
Medical technology company Kinetic Concepts (KCI) has initiated patient enrollment in a multi-center clinical study that will assess the advantages of negative pressure wound therapy (NPWT) with intermittent instillation therapy with a ...
Tags: Health, Medicine, Medical technology
Beckman Coulter, a subsidiary of Danaher Corporation, has received 510(k) approval from the US Food and Drug Administration (FDA) for its new Access AccuTnI+3 troponin I assay for use in its Access 2 immunoassay system. In October 2010, ...
Tags: Beckman Coulter, Medicine