ATLANTA – Back in 2010, the FDA held two meetings to discuss the accuracy and safety of glucose meters. During the meetings the agency pushed for tightening system accuracy criteria specified by current glucose meter standards and considered whether FDA review criteria for these devices should be changed to promote the public health. The FDA solicited feedback from clinical experts about the clinical requirements for blood glucose meter accuracy and precision, and the benefits and risks of using glucose meters to achieve and maintain tight glycemic control. (Medical Device Daily)
ATLANTA — Is opening the door for direct-to-consumer (DTC) genomic testing actually opening pandora's box? A small panel took on that question Tuesday during the American Association for Clincal Chemistry (AACC; Washington) meeting held here at the Georgia World Congress Center. (Medical Device Daily)
ATLANTA — A picture displaying what appears to be part of a female's abdomen pops up on the screen – with the words next to it "The fastest growing cancer among women isn't what you think." (Medical Device Daily)
ATLANTA — To just say that Mary-Claire King PhD, has simply been "instrumental" in the way physicians look at diagnosing breast cancer would be an understatement. King was a pioneer in helping the medical community understand the BRCA1 gene and its role of genetics in the development of breast and ovarian cancer. (Medical Device Daily)
Cardinal Health (Dublin, Ohio) reported that it has opened The Center for the Advancement of Molecular Imaging – a collaboration that will expedite the development of nuclear imaging agents that treat complex diseases like cancer, heart disease and neurological disorders. (Medical Device Daily)
For years children suffering with early onset scoliosis had to have multiple surgeries to correct spinal deformities. A small med-tech company is aiming to change that standard of care, with an implant that can be adjusted in the patient after it's implanted, remotely. (Medical Device Daily)