The FDA has granted breakthrough device designation to Endologix LLC for its Chimney Endovascular Aneurysm Sealing (ChEVAS) system. The device, which is intended for use in treating aortic aneurysms, is currently being evaluated in a multicenter pivotal study. The ChEVAS system is an endovascular abdominal aortic aneurysm (AAA) therapy designed to combine the Nellix 3.5 endograft with parallel visceral chimney stents to enable treatment of patients with juxtarenal, pararenal and suprarenal AAA. Read More
LONDON – U.K. rapid diagnostics specialist Mologic Ltd. has been acquired by a group of philanthropists led by George Soros’ Economic Development Fund and the Bill & Melinda Gates Foundation, and will be turned from a for-profit company to a social enterprise. The aim is to use the change in status to expand access to low-cost point-of-care testing for tropical diseases, including dengue, bilharzia and river blindness, as well at COVID-19. The name Mologic will be changed to Global Access Health (GAH), with the philanthropic owners saying they are to invest at least $41 million in the deal. Read More
On the heels of enrolling the first patient in a pivotal trial of a ventricular restoration system to treat symptomatic heart failure patients in January, Ancora Heart Inc. closed $80 million in new financing on Monday. The startup company plans to use the new funding to speed up this pivotal trial in preparation for FDA approval of its Accucinch ventricular restoration system. Read More
The FDA is applying a good deal of resources toward a framework for regulation of artificial intelligence (AI) and machine learning (ML), but there are several sources of drag on those efforts. According to the FDA's Jana Delfino, one of these is that there is little agreement between regulators on a number of definitions, including the meaning of terms such as "validation," a problem she said must be solved if the field is to advance in a meaningful manner. Read More
A research team from the National University Health System (NUHS) was awarded a translational grant of S$4.9 million (US$3.6 million) from the National Research Foundation Singapore Central Gap Fund to further develop its personalized mitral valve bioprosthesis. Currently, around 500 patients in Singapore and more than 1 million around the world require mitral valve surgery annually. Read More
Aditxt Technologies Inc. enhanced its immune response test for COVID-19 by adding a high-sensitivity neutralizing antibody quantification. With the expansion, the multidimensional test, Aditxtscore, provides a comprehensive measure of the strength of an individual's immune response to the novel coronavirus. Read More
The Organization for Economic Cooperation and Development (OECD) announced a two-pillar plan for reform of international rules of taxation that would update rules said to be insufficient for the 21st Century economy. The proposal, a joint effort of the OECD and the G20, is to apply a minimum tax rate of 15% on goods shipped across national boundaries, thus putting an end to tax havens that have been used to avoid taxes. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aquarius Surgical Technologies, Bioivt, BIRD Foundation, Carmat, Flywheel, Rochal Industries, Sanara Medtech, Siemens Healthineers, Tissue Solutions. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Endologix, Nevro. Read More
