FDA Approvals - FDA Decision Endorsed By Leading Texas LAP-BAND Team True Results
FDA Decision Endorsed By Leading Texas LAP-BAND Team True Results
The True Results team of gastric band surgeons and medical weight loss experts is pleased the U.S. Food and Drug Administration (FDA) has recognized the long-standing safety and effectiveness record of the LAP-BAND System. This ruling will now allow millions of additional Americans to qualify for earlier weight-loss intervention...
Agendia Receives Fifth FDA Clearance For Industry Leading MammaPrint(R) Assay
Agendia, a world leader in molecular cancer diagnostics, announced that the company has received its fifth U.S. Food and Drug Administration (FDA) clearance for MammaPrint(R), its widely used breast cancer recurrence assay. The new clearance is comprised of two additional Agilent Microarray scanners and two Agilent Bioanalyzers, expanding laboratory capacity to handle the increasing number of ...
Report critical of device approvals
CHICAGO Most medical devices recalled in recent years because of deaths or life-threatening problems were cleared for approval under less stringent regulations that don t require human testing, an analysis found.