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
Cartiva, a developer of orthopedic implants, has completed enrolling patients in its MOTION trial. The prospective, multi-center trial, which has enrolled 233 patients across Canada and the UK, is designed to assess the company's ...
Tags: Cartiva, clinical trial, clinical technology
Boston Scientific has obtained CE mark approval for its Synergy Everolimus-Eluting platinum chromium coronary stent system, designed to improve post-implant vessel healing. The coronary stent, which features a combination of ...
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
ETView Medical has obtained CE mark approval for its VivaSight-DL airway management system. Single-use, disposable VivaSight-DL system comprises of a dual lumen airway ventilation tube with an integrated, continuous high-resolution video ...
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
Abbott has obtained the US Food and Drug Administration (FDA) approval for its Omnilink Elite Vascular Balloon-Expandable Stent system, designed as a treatment for atherosclerotic iliac artery lesions with reference vessel diameters of ≥ ...
Tags: Abbott, FDA, approval, Omnilink Elite stent, study, Omnilink Elite
The US Food and Drug Administration (FDA) has granted 510(k) approval to Cardiosolutions' Dexterity Steerable Introducer. The Dexterity Steerable Introducer is designed to simplify the cardiac trans-septal procedure and facilitates ...
Cohera Medical has gained investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to commence the first no-drain clinical trial of its internal surgical adhesive. Designed for use during abdominoplasty ...
Tags: Cohera Medical, Cohera, Surgical Adhesive, surgeries
The US Food and Drug Administration (FDA) has cleared Codman & Shurtleff's pre market approval (PMA) application of Medstream Programmable Infusion system, designed as a treatment for spasticity caused by stroke, cerebral palsy, multiple ...
Tags: FDA, Medstream Programmable Infusion system, Medstream system
Novation has submitted comments to the US Food and Drug Administration (FDA) in support of Unique Device Identification (UDI) system for medical devices. The company believes that the proposed UDI rule, designed to overcome the ...
Tags: Novation, comment, FDA, UDI system, medical devices
American Medical Systems (AMS), an Endo Health Solutions company, and Allergan have entered into an agreement to jointly develop and seek regulatory approval for the delivery of Botox (onabotulinumtoxinA) using the JetTouch system. ...
Tags: AMS, JetTouch system, medical application