Roche has gained US marketing rights for its new wireless hospital blood glucose monitoring system following the Food and Drug Administration's (FDA) approval. The new point-of-care system, ACCU-CHEK Inform II meter, uses a new patented ...
Tags: Roche, hospital blood glucose monitoring system, FDA, approval
The US Food and Drug Administration (FDA) has granted 510(k) clearance to TomTec Imaging Systems' new image management solution. The Image-Com 5 software solution, which is the newest addition to TomTec's Image-Arena image management ...
The US Food and Drug Administration (FDA) has cleared Carestream's new lesion management module, designed to help enhance both diagnostic confidence and radiologist productivity. The new tool, which is designed for use with the ...
Bracco Diagnostics has obtained the US Food and Drug Administration (FDA) clearance for use of its MultiHance (gadobenate dimeglumine) injection, 529 mg/mL, in magnetic resonance angiography (MRA), designed to evaluate adults with known or ...
Tags: FDA, Bracco, clearance, MultiHance injection, MRA
ALK has entered into an collaboration agreement to supply its FDA approved skin test for the diagnosis of penicillin allergy, PRE-PEN (benzylpenicilloyl polylysine injection USP), to HealthTrust Purchasing Group. Under the agreement, ...
Tags: ALK, collaboration agreement, skin test, penicillin allergy, PRE-PEN
EndoGastric Solutions announced that patient enrollment has been completed for its Transoral Incisionless Fundoplication (TIF) versus Medical Proton Pump Inhibitor (PPI) Management of Refractory GERD symptoms (TEMPO) trial. The ...
Tags: EndoGastric, patient enrollment, TIF, TIF procedure trial, TEMPO trial
Aptus Endosystems, a developer of endovascular aneurysm repair (EVAR) technology, has completed $25m series BB equity financing. Aptus will use the finance to expand commercialization of its HeliFX Aortic Securement system in the US and ...
Tags: Aptus Endosystems, endovascular aneurysm repair technology
The US Food and Drug Administration (FDA) has cleared VBOX's portable oxygen concentrator for use on a prescriptive basis by patients requiring supplemental oxygen. Trooper concentrator, which can be worn over the shoulder or around the ...
Tags: FDA, VBOX's portable oxygen concentrator, Trooper concentrator
CardioComm Solutions is seeking FDA clearance for its GUAVA II, a new ECG viewer with ECG algorithm technologies. GUAVA is a medical software device with a formal Application Programming Interface (API) and can be incorporated from Host ...
Tags: CardioComm, FDA, clearance, GUAVA II, ECG viewer
The revised product labelings of Boston Scientific's Incepta, Energen, Punctua, Cognis and Teligen implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) have been cleared by the US Food ...
Tags: FDA, medical technology, medical application
The US Food and Drug Administration (FDA) has cleared Loma Vista Medical's TRUE Dilatation Balloon Valvuloplasty catheter, designed to prevent balloon ruptures in balloon aortic valvuloplasty (BAV) and transcatheter aortic valve ...
Tags: FDA, Loma Vista, Balloon Valvuloplasty catheter, BAV
The US Food and Drug Administration (FDA) has cleared r4 Vascular's high pressure Vector percutaneous transluminal angioplasty (PTA) balloon catheters for treating vascular narrowings lesions and blockages. Patent pending Vector PTA ...
Tags: FDA, PTA, balloon catheters, vascular narrowings lesions, r4 Vascular
American medical devices developer Catheter Connections has roped in Merit Medical Systems for the distribution of its DualCap technology for IV connector disinfection and protection. Both firms have entered into a distribution agreement, ...
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Teleflex for its new disposable endobronchial blocker. The Rusch EZ-Blocker features a bifurcated distal end and dual bronchial cuffs, which allow physicians to ...
Tags: FDA, disposable endobronchial blocker, clinical product
Medtronic has introduced the Endurant II AAA Stent Graft system in the US, following the US Food and Drug Administration's (FDA) approval. The Endurant II AAA Stent Graft system is designed for the treatment of abdominal aortic aneurysms ...
Tags: Medtronic, Endurant II AAA Stent Graft system, FDA, EVAR