Devices

Instrumentation Lab Gains 510(k) Clearance for Assay

FDA has cleared an Instrumentation Laboratory 510(k) for the HemosIL AcuStar HIT-IgG(PF4-H) Assay and HemosIL AcuStar HIT Controls. The assay is described by the company as the “first on-demand, fully automated, chemiluminescent reagent on a hemostasis testing system for the qualitative detection of platelet factor 4 (PF4)-heparin complex IgG antibodies associated with Heparin-Induced Thrombocytopenia (HIT).” It is intended to detect HIT antibodies on ACL AcuStar Hemostasis Testing Systems in specialty and hospital Hemostasis laboratories. “Now hospitals and specialty labs can perform HIT testing 24/7 on the ACL AcuStar Testing System with no special training required,” it says.

HIT is a severe immunologic adverse reaction to a Heparin complex that causes blood clots to form, leading to venous or arterial thrombosis, and can be fatal. “Diagnosis of HIT is key to positive patient outcomes and may prompt initiation of alternative anticoagulants,” the company says.

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

Read more

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