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Hologic, Inc. is an American medical technology company primarily focused on women's health; it sells medical devices for diagnostics, surgery, and medical imaging. [ 2 ] History
The FDA said the recall of the device BioZorb Marker, initiated by Hologic in March, was not a product removal, but a correction. The agency also urged patients to report any side effects they ...
Additional FDA approval for Hologic's (HOLX) molecular diagnostic test is expected to aid in the diagnosis of HIV infection.
The FDA's modified EUA for Hologic's (HOLX) Aptima SARS-CoV-2 assay includes testing of asymptomatic individuals and symptomatic pooling protocol to curb the spread of coronavirus.
The average procedure time is 26 minutes. In the HTA randomized controlled trial for FDA approval, the success rate was 68% and amenorrhea rate was 35%. [14] The Her Option – Endometrial Ablation System, FDA approved in 2001, is a treatment that creates sub-zero temperatures to freeze and ablate the endometrium.
SurePath (by BD) and ThinPrep (by Hologic) are two such systems currently approved by the United States Food and Drug Administration (FDA) for cervicovaginal testing. With both methods, the sample is collected in the conventional manner with one of the brush instruments but, instead of being spread onto a glass slide, it is transferred to a ...
The company's devices, BioZorb Marker and BioZorb LP Marker, are implanted in soft tissue, including breast tissue, where the site needs to be marked for future procedures, such as radiation for ...
The hologic software DCE-MRI allowed Hylton to monitor breast cancer response in real time. [17] [18] The software was FDA IDE approved in 2010. [17] Hylton demonstrated in 2010 that MRI could be used to predict how women will respond to neoadjuvant therapy.