It is this latter approach which has been utilized by all of the FDA-approved devices for the reduction of postoperative intra-abdominal and pelvic adhesions, including Seprafilm.
This is an FDA-cleared device.
Last month, the federal Government Accountability Office and a congressional committee revealed that Coast IRB had approved a fake study of a fictitious FDA-approved device.
BodyMedia, the band that gave me the most eye-opening results, boasts that is a FDA-approved device and is used in research projects.
A Harvard-designed sperm motility app made headlines last week with a cheap, at-home test, and now YO, a "sperm selfie" app and FDA-approved device, has just started shipping.
Another FDA-approved device for glucose monitoring without the prick called the GlucoWatch was approved in the early 2000's, but consumers found it cumbersome and it happened to cause a bad rash in some.
As a public-health response to an increase in false-positive test results from an FDA-approved device, CDC determined the study did not require Institutional Review Board IRBB) review under human-subjects-protection guidelines.
Thus, this report is the most comprehensive to date on an FDA-approved device for this unique form of prosthetic fixation.
The CellSearch System (Veridex LLC, Raritan, New Jersey, U.S.A) is an FDA-cleared device for CTC detection using enrichment for cells in the blood expressing the epithelial cell adhesion marker (EpCAM) [ 6].
In an effort to determine a less expensive, quicker and safer alternative to endoscopic biopsy, we wondered whether mucosal eosinophilia associated with EoE could be assessed in a less invasive manner using an FDA-approved device, the Enterotest.
The MEA used in this study is an FDA-approved device (NeuroportTM neural monitoring system, Cyberkinetics Neurotechnology Systems, Foxboro, MA) that has been safely implanted in humans at several institutions (Hochberg et al., 2006; House et al., 2006; Waziri et al., 2009).
