ChemBio’s Zika Virus Assay Gains Brazilian Approval
Chembio Diagnostics announced that it has received approval for commercial use of its DPP Zika IgM/IgG Assay by the Brazilian health regulatory agency, Agência Nacional de Vigilância Sanitária (ANVISA). Chembio's DPP Zika IgM/IgG Assay detects antibodies using a tiny (10uL) drop of blood from the fingertip and provides semi-quantitative results in 15 minutes, using Chembio's patented DPP technology platform and handheld, battery-operated DPP Micro Reader.
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Favorable Results for St. Jude’s AMPLATZER Amulet LAA Occluder at TCT
Data regarding St. Jude Medical’s AMPLATZER Amulet LAA Occluder were presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference, proving the device demonstrated high implant success and a strong safety profile. The AMPLATZER Amulet LAA Occluder is used to close the LAA (an appendage of the left atrium) in patients diagnosed with non-valvular AF. Other findings presented included a 99% closure rate at one to three month follow up and 2.7% of patients experienced acute device/procedure related major adverse events within seven days.
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Optune Receives Positive Coverage Decision from United Healthcare
Novocure announced that United Healthcare will cover Optune as an adjunctive therapy for the treatment of glioblastoma (GBM) when used according to U.S. Food and Drug Administraion (FDA) labeled indications and contraindications, effective Jan. 1, 2017. As of Jan. 1, 2017, more than 177 million Americans will have coverage of Optune, a portable, noninvasive device that delivers Tumor Treating Fields (TTFields) therapy to patients with newly diagnosed and recurrent GBM. United Healthcare’s positive coverage policy of Optune adds to positive coverage policies from Harvard Pilgrim Healthcare, Oregon Health Plan and Blue Cross Blue Shield of Arizona.
See more information on Optune on Meddevicetracker.