Devices

Chembio Expects HIV/Syphilis Approval in 2 Months

Chembio Diagnostics says it expects FDA approval in two months on its PMA for the DPP HIV-Syphilis System. The single-use, 15-minute screening test simultaneously detects antibodies to HIV Types 1 and 2 and the bacteria that causes syphilis, Treponema pallidum. It uses a 10 microliter sample of fingerstick whole blood, venous whole blood, or plasma, according to the company. It also has a built-in procedural control, can be stored at room temperature, and has up to a 24-month shelf life.

The company says its clinical study, which included the prospective enrollment of over 2,500 subjects, demonstrated that the device met FDA-established performance requirements. It also says it provided additional requested studies, which included data on pregnant women.

According to Chembio, co-infection rates of HIV and syphilis are on the rise and those with an active syphilis infection have an estimated two-to-five-fold increased risk of contracting HIV if exposed to the virus. Further, it says about two million pregnancies annually are affected by mother-to-child-transmission of HIV and/or syphilis, resulting in high rates of stillbirth, spontaneous abortion, low birth weight, and perinatal death.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome