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The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Advamed, Resmed, Abbott Vascular, Teleflex Medical.
Acutus Medical Inc. is working to build itself into a major competitor in cardiac electrophysiology. The latest step to do so is an FDA clearance for its second-generation cardiac mapping software known as Supermap. This works in conjunction with its next-gen Acqmap 3D Imaging and Mapping System. The Carlsbad, Calif.-based startup, which was founded in 2011, is now marketing these in both the U.S. and Europe, where Supermap received a CE mark in October 2019.
A lot of development dollars are shed when the FDA withdraws approval or requests that a drug be withdrawn from the market because new potential risks have come to light. And it’s not just the brand company that feels the loss.
The latest mutation to the coronavirus, dubbed COVID-19, has sparked a reaction by many national governments, but the expense associated with development of vaccines and diagnostics is considerable.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: 10X Genomics, Bio-Rad Laboratories, Sanofi SA.
Fisher Wallace Laboratories of New York has filed a citizen’s petition with the U.S. FDA regarding the agency’s proposed class III designation for cranial electrotherapy stimulators (CES) for treatment of depression. The company argued that the agency disallowed evidence at an advisory hearing regarding this therapy provided by direct rather than alternating current, but also that the FDA had reneged on an earlier decision to classify these devices as class II devices.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Brainsway, National Government Services, Wisconsin Physician Services.
Eisai Co. Ltd. is removing Belviq (lorcaserin) from the U.S. market due to the FDA’s concerns about an increased occurrence of cancer in a long-term trial evaluating the cardiovascular effects associated with the weight-loss drug.
BEIJING – China will kickstart a phase III trial Feb. 3 to determine whether patients with 2019-nCoV can be treated with Gilead Sciences Inc.’s NUC inhibitor,...
HONG KONG – In another example that communication is proving as difficult as containment in the current coronavirus outbreak, China’s state media reported, to...
HONG KONG – A team of researchers at Hong Kong University of Science and Technology (HKUST) claim to have invented the world’s fastest portable 2019-nCoV...
HONG KONG – As drug developers are racing to find a cure for the new coronavirus, researchers in Hong Kong claim to have made major headway in the development of...
BEIJING – Chinese regulators are speeding up to approve more test kits for the deadly coronavirus that already has killed 170 people and infected more than 7,700...
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