Makers of devices for ablation for atrial fibrillation (AF) have struggled at times to overcome clinician skepticism, but a new report in a respected medical journal might persuade some of those cardiologists. A study of nearly 28,000 AF patients in South Korea demonstrated that device therapy yielded lower rates of death and admission for heart failure compared to medical therapy, suggesting that ablation is a valid alternative to medical therapy, at least for patients in Asia.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is pushing back implementation dates for numerous medical device reforms due to delays caused by the COVID-19 pandemic.
HONG KONG - Mumbai-based Glenmark Pharmaceuticals Ltd. has been granted manufacturing and marketing approval for the launch of its antiviral drug, favipiravir, for the treatment of mild to moderate COVID-19, a move it deems a “landmark development for COVID-19 patients in India.”
HONG KONG – Singapore-based Igene Laboratory, a wholly owned subsidiary of Inex Innovate Pte. Ltd., has launched a noninvasive prenatal test (NIPT) that assesses fetal Rhesus factor (RhD) status from a maternal blood sample.
HONG KONG – India’s Ministry of Health and Family Welfare (MOHFW) has drafted rules for the manufacturing, import and the compassionate use of unapproved drugs in the treatment of patients.
HONG KONG – Korea’s Celltrion Inc. aims to wrap up its first major M&A deal with Japan’s Takeda Pharmaceutical Inc. by the end of 2020, pending approvals.
HONG KONG – China and U.S.-based Lisen Imprinting Diagnostics Inc. has unveiled its Quantitative Chromogenic Imprinted Gene In-Situ Hybridization (QCIGISH) technology, a novel approach for identifying, visualizing and quantifying the biallelic and multiallelic expressions of an imprinted gene panel associated with cancer status.
HONG KONG – Korea’s Celltrion Inc. aims to wrap up its first major M&A deal with Japan’s Takeda Pharmaceutical Inc. by the end of 2020, pending approvals.
PERTH, Australia – The majority of stakeholders support the Therapeutic Goods Administration’s (TGA) proposal to restructure Australia’s device essential principles to align with the requirements under the new EU Medical Device Regulations (EU MDR), but there was little support to align with the International Medical Device Regulators Forum (IMDRF) essential principles and principles of labeling.