Syneron Medical has received the US Food and Drug Administration (FDA) approval for its new elos Plus multi-platform device. The new elos Plus device utilizes the company's proprietary elos technology of optical energy and bi-polar ...
Tags: FDA, elos Plus multi-platform device, medical technology
GenMark Diagnostics has obtained the US Food and Drug Administration's (FDA) 510(k) clearance for its eSensor Respiratory Virus Panel, designed for use on its XT-8 system. The test is intended to simultaneously detect and differentiate 14 ...
Tags: GenMark, FDA clearance, eSensor Respiratory Virus Panel, XT-8 system
The US Food and Drug Administration (FDA) has granted 510(k) clearance to AngioDynamics' BioFlo peripherally inserted central catheters (PICCs) with a permanent and non-eluting integral polymer Endexo technology. The BioFlo PICCs is ...
Tags: FDA, clearance, PICCs, BioFlo PICCs, PASV Valve technology
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
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
Spacelabs Healthcare, a division of OSI Systems, has received the US Food and Drug Administration's 510(k) approval for its Blease900 ventilator. The Blease900 ventilator, which is an integral component of its BleaseFocus anesthesia ...
Tags: FDA, OSI Systems, Blease900 ventilator
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
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Covidien's Nellcor bedside SpO2 patient monitoring system. The Nellcor bedside SpO2 monitor, which utilizes OxiMax technology, is designed for detecting heart rate ...
Tags: FDA, clearance, Nellcor, SpO2 patient monitoring system, SpO2 monitor
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
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Corindus Vascular Robotics' CorPath 200 system, designed to restore blood flow to blocked arteries in patients with coronary artery disease. The CorPath 200 system, ...
Tags: CorPath 200 system, robotically-assisted PCI, coronary artery disease
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
Spacelabs Healthcare, a division of OSI Systems, has received 510(k) approval from the US Food and Drug Administration (FDA) for its AriaTele telemetry transmitter. AriaTele transmitter features an onboard display screen that presents ...
Tags: Spacelabs Healthcare, OSI Systems, AriaTele telemetry transmitter
Roche's Accu-Chek Combo system has been cleared by the US Food and Drug Administration (FDA) for insulin pump therapy. The Accu-Chek Combo system features an insulin cartridge that can hold up to 315 units of insulin, as well as a ...
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Vitacon's VitaScan LT USB bladder scanner, designed for measuring bladder volume in real-time which avoids the placement of indwelling urethral catheters, a major ...
Tags: bladder scanner, FDA, clinical device
Globus Medical has obtained premarket approval (PMA) from the US Food and Drug (FDA) for its articulating intervertebral disc replacement device, designed for patients with intractable symptomatic cervical disc disease (SCDD) between ...
Tags: FDA, articulating intervertebral disc replacement device