GeNO has obtained a clearance for its inhaled nitric oxide (NO) delivery system, GeNOsyl MV-1000, from the US Food and Drug Administration (FDA). GeNOsyl MV-1000 system, which incorporates a primary delivery system, a backup system, ...
Tags: FDA, inhaled nitric oxide delivery system, clinical product, GeNO
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Biosign Technologies' non-invasive blood pressure measurement system, Pulsewave monitor. The UFIT EN-10 monitor is worn on the wrist having 13.5 cm to 23 cm (5.3 ...
Tags: FDA, blood pressure measurement system, pulsewave monitor, systolic
The US Food and Drug Administration (FDA) has granted de novo petition to market Nanosphere's gram-positive blood culture nucleic acid test (BC-GP) on the automated sample-to-result Verigene system. Single automated BC-GP test detects ...
Tags: Nanosphere, FDA, BC-GP test, Verigene system
Qiagen has won the US Food and Drug Administration (FDA) approval for its new molecular companion diagnostic product, therascreen KRAS RGQ PCR test kit, to provide guidance on the use of Erbitux for approximately 110,000 US patients with ...
Tags: Qiagen, FDA, molecular companion diagnostic product, test kit
Accuray has received 510(k) clearance for its new CyberKnife M6 Series from the US Food and Drug Administration (FDA). Designed for use in stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) treatments, the ...
Tags: FDA, stereotactic radiosurgery, stereotactic body radiation therapy
The US Food and Drug Administration (FDA) has approved the use of Associates of Cape Cod's rapid diagnostic test in detecting invasive fungal infections (IFI). Using patient's blood serum, the Fungitell assay detects (1,3)-b-D-glucan ...
Tags: detecting invasive fungal infections, fungal pathogens, IFI
Global provider of medical device solutions Symmetry Medical has obtained United States Food and Drug Administration's (for its FLASH PAK Evolution valve. The valve, which is distributed exclusively by Symmetry Surgical, is designed ...
Tags: medical device solutions, Symmetry Medical, Symmetry Surgical
OptiMedica has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its new Catalys Precision Laser system, designed for creating single-plane and multi-plane arc cuts/incisions in the cornea during performing ...
Tags: OptiMedica, US Drug Administration, Catalys Precision Laser system
The US Food and Drug Administration (FDA) has granted premarket approval (PMA) to Roche's new fully automated COBAS AmpliPrep / COBAS TaqMan CMV test to quantify cytomegalovirus' (CMV) DNA in human plasma specimens. The real-time ...
Tags: Roche, FDA, Viral Load Test, PCR-based CMV test
The US Food and Drug Administration (FDA) has cleared Siemens Healthcare's Somatom Perspective128-slice computed tomography (CT) scanner. The company said on the Somatom CT scanner, Sinogram affirmed iterative reconstruction (SAFIRE), a ...
Tags: Siemens scanner, CT scanner, scanner, computed tomography scanner