The AtriCure has obtained the US Food and Drug Administration (FDA) clearance to commence three-year Ablate post approval study (PAS), designed for the surgical correction of atrial fibrillation. The 350 patient study is designed to ...
Tags: AtriCure, FDA clearance, post approval study, PAS, Synergy ablation system
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 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
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, ...
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
Cook Medical has received the US Food and Drug Administration (FDA) approval for its new Evolution colonic controlled-release stent. The new stent design features Kink-resistant flexor technology-based delivery system for pushability ...
Tags: Cook Medical, FDA, medical technology
Cook Medical has received the regulatory approval from the US Food and Drug Administration (FDA) for its Zilver PTX drug-eluting peripheral stent, designed for treating peripheral arterial disease (PAD) in the superficial femoral artery. ...
Tags: Cook Medical, FDA, peripheral arterial disease, clinical product
Thermedical has obtained 510(k) clearance for its radiofrequency-based thermal ablation system, designed for treating large volumes of solid tumors, from the US Food and Drug Administration (FDA). Featuring a single or more needles, the ...
Tags: Thermedical, thermal ablation system, FDA, radiofrequency waves, approval
Boston Scientific has received the US Food and Drug Administration (FDA) approval for 32 mm and 38 mm lengths of the Promus Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent system. The Promus Element Stent is made with a ...
Tags: FDA, Boston Scientific, Promus Element Stent, coronary artery disease
Avinger has completed enrolling peripheral artery disease (PAD) patients in its CONNECT II clinical trial. The prospective, multi-center, non-randomized trial that evaluated 100 PAD patients with femoropopliteal CTO lesions was ...
Tags: clinical trial, peripheral artery disease, clinical technology, Avinger
Cordis has obtained regulatory approval from the US Food and Drug Administration (FDA) to use its S.M.A.R.T. CONTROL Vascular Stent systems in the superficial femoral artery (SFA) and/or the proximal popliteal artery (PPA). The Stent ...
Tags: FDA, Stent systems, proximal popliteal artery, superficial femoral artery
Stryker Neurovascular has obtained the US Food and Drug Administration's (FDA) approval for its new clot removal technology, Trevo Pro Retriever. By utilizing proprietary Stentriever technology, the Trevo Pro Retriever removes blood clots ...
Tags: Stryker Neurovascular, FDA, approval, clot removal technology
BioControl Medical is set to commence the second phase of its INcrease Of VAgal TonE in Heart Failure (INOVATE-HF) study, following the US Food and Drug Administration (FDA) approval. The CardioFit system, which comprises a stimulator, a ...
Tags: BioControl Medical, INcrease Of VAgal TonE in Heart Failure study
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 ...