Osteologix IND For NB S101 For Osteoporosis Accepted By FDA (Medical News Today)
Osteologix, Inc. (OLGX.OB), a specialty biopharmaceutical company, announced that the U. S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for its lead development candidate NB S101 (strontium malonate), for the treatment and prevention of osteoporosis.

ParagonDx Receives FDA 510(k) Marketing Clearance For Warfarin Sensitivity Genotyping Kit (Medical News Today)
ParagonDx, a leader in genetic testing diagnostics, has received 510(k) marketing clearance from the US Food and Drug Administration (FDA) for its in vitro diagnostic test. The Rapid Genotyping Assay is to be used to detect the presence of variations in the genes CYP2C9 and VKORC1.

St. Jude Medical Announces FDA Clearance and CE Mark Approval of Strada Carotid Guiding Sheath (Centre Daily Times)
St. Jude Medical, Inc. (NYSE:STJ) today announced U.S. Food and Drug Administration (FDA) clearance and European CE Mark approval of the Strada(TM) Carotid Guiding Sheath, a flexible tube through which physicians can deliver balloon catheters, stents and other tools to open blockages in the carotid arteries. The Strada Carotid Guiding Sheath is designed specifically to provide easier and faster ...