The US Food and Drug Administration (FDA) has approved Immunetics' BacTx rapid test to detect bacterial contamination in platelet units. The clearance allows BacTx test to use on leukocyte-reduced whole blood-derived platelet units, a ...
Microsulis Medical has obtained the US Food and Drug Administration's (FDA) approval for upgraded version of its Accu2i pMTA applicator, designed for use as part of the company's Acculis Microwave Tissue Ablation (MTA) system. The Accu2i ...
Tags: Medical, microwave tissue ablation applicator, applicator
Teleflex's Arrow FlexTip Plus Closed Tip, multi-port epidural catheter has been granted 510(k) clearance by the US Food and Drug Administration (FDA). The Arrow FlexTip Plus Closed Tip catheter utilizes the same technology of the ...
The Medicines Company has agreed to buy Incline Therapeutics for an upfront payment of $185m. Incline, a hospital-focused specialty pharmaceutical company, produces a needleless patient-controlled IONSYS (fentanyl iontophoretic ...
Tags: Medicines Company, Incline Therapeutics, pharmaceutical company
Healthcare products company Covidien has received Health Canada's approval for its revascularization device. The FDA-cleared and CE mark approved Solitaire FR device restores blood flow to the brain in patients with acute ischemic stroke, ...
Tags: FR revascularization device, Healthcare products, Treatment
C. R. Bard's Lutonix technology center has completed enrolling patients in its pivotal investigational device exemption (IDE) LEVANT 2 trial, designed to evaluate Lutonix drug coated PTA dilatation catheter (DCB) as a treatment for ...
Tags: pivotal investigational device, drug coated PTA dilatation catheter
The US Food and Drug Administration (FDA) has cleared Boston Scientific's subcutaneous implantable cardioverter defibrillator (S-ICD) to treat patients at risk for sudden cardiac arrest (SCA). The CE-marked system, which the company ...
Tags: FDA, CE-marked system, S-ICD system
Tangent Medical has gained FDA 510(k) clearance for the NovaCath Secure IV Catheter System designed to address peripheral IV challenges including catheter stabilization, healthcare worker safety, tubing management and patient comfort. ...
Tags: FDA, Catheter System, medical device, clinical technology
The US Food and Drug Administration (FDA) has cleared Covalon's SurgiClear antimicrobial silicone adhesive film dressing. SurgiClear antimicrobial silicone dressing is designed to cover and protect wound sites and wound closure ...
Tags: FDA, dhesive film dressing, clinical product, clinical application
The US Food and Drug Administration (FDA) has granted 510(k) approval to Avery Dennison Medical Solutions' new non-cytotoxic, grade 0 profile transparent wound film dressing, designed to treat catheter-related blood stream infections. ...
Tags: FDA, wound film dressing, clinical product, clinical application
These sustainable blister film solutions offer viable alternatives to films containing PVC and are available in all standard thicknesses and combinations. The films provide equivalent performance, enhanced processability and increased ...
Tags: blister film, films, pharmaceutical products
The US Food and Drug Administration (FDA) has granted 510(k) approval to Surefire Medical's High-Flow Microcatheter. The Surefire Microcatheter, comprising of expandable tip, is designed to deliver therapy with higher infusion ...
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Surefire Medical's new line of Angiographic catheters. Angiographic Catheter line features a large inner lumen of 0.054 inches which enables interventional ...
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Zynex's InWave device, designed for treating female urinary incontinence. Following the approval, the company said the InWave device will be manufactured, ...
Tags: FDA, female urinary incontinence, clinical application, clinical product
Agilent Technologies has signed an agreement to supply its nuclear magnetic resonance (NMR) components for use in LipoScience's automated Vantera Clinical Analyzer. The FDA-cleared Vantera Clinical Analyzer combines proprietary ...
Tags: Agilent, NMR, clinical technology, clinical application