Cardica, a medical device company, has received 510(k) approval from the US Food and Drug Administration (FDA) for its MicroCutter Xchange 30 device and blue staple cartridge for medium thickness tissue. The company has designed the ...
Tags: Cardica, medical device
Corgenix Medical, in collaboration with Randox Laboratories, has filed first 510(k) premarket notification with the US Food and Drug Administration (FDA) for the TxBCardio immunoturbidimetric assay. According to Corgenix Medical, ...
"The iTrace for Blood Centers device has the ability to enhance blood safety by helping to ensure that unsuitable units are not released," said Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research. "iTrace ...
Tags: Blood Tracking Device, Health, Medicine
Anaxsys has filed its respiR8 continuous respiratory rate counter's 510(k) premarket notification application with the US Food and Drug Administration (FDA) for regulatory clearance. Electrochemical respiR8 device comprises a patented ...
Tags: Anaxsys, Electrochemical respiR8 device, FDA
GeNO has received four additional US patents for its proprietary nitric oxide (NO) generation chemistry and delivery technology. The patent No. 8,211,368 describes the conversion of nitrogen dioxide (NO2) to NO where NO2 is stored as ...
Tags: US patent, clinical technology, clinical research, GeNO
BG Medicine has registered a 510(k) premarket notification with the US Food and Drug Administration (FDA) for approval of its Architect Galectin-3 assay. The Architect Galectin-3 assay, which is designed for use with Abbott's automated ...
Tags: BG Medicine, premarket notification, FDA, Architect Galectin-3 assay
Inhaled nitric oxide drug products developer GeNO has received four additional US patents on its proprietary inhaled nitric oxide (NO) generation chemistry and delivery technology, bringing the total number of US patents to sixteen. The ...
Tags: inhaled nitric oxide drug, NO, NO2, GeNO
BG Medicine has filed 510(k) premarket notification for regulatory clearance of an expanded indication for its BGM Galectin-3 test with the FDA. The blood test is at present indicated for use in patients with chronic heart failure who are ...
Tags: BG Medicine, blood test, heart failure
Cardiovascular diagnostics developer BG Medicine has filed a 510(k) Premarket Notification with the US Food and Drug Administration (FDA) for regulatory clearance for the ARCHITECT Galectin-3 assay. Used with Abbott's fully automated ...
The US Food and Drug Administration (FDA) has granted 510(k) approval to Olea Medical's Olea Sphere medical imaging enterprise software. Olea Sphere provides display, analysis and post-processing functionality for viewing perfusion ...
Tags: medical imaging enterprise software, imaging enterprise software