The U.S. FDA has given its nod for a new trial of Abbott Laboratories’ Amplatzer Amulet left atrial appendage (LAA) occluder for those with atrial fibrillation (AF) who are at risk of stroke. Known as the CATALYST trial, it is the first study comparing the effectiveness of a LAA closure device to non-vitamin K antagonist oral anticoagulant (NOAC) drugs, a newer class of blood thinners, the Abbott Park, Ill.-based company said. Read More
As the deadly coronavirus continues to spread, countries around the world are scrambling to understand the public health threat and identify and quarantine people who may be infected. To that end, Novacyt SA has launched a molecular test that detects only the 2019 strain of the coronavirus, reducing the chance of false diagnoses. Read More
The U.S. Department of Health and Human Services has declared a public health emergency in the U.S. over the coronavirus in part because a government diagnostic for the virus yields inconsistent results, a fact that may spur the life sciences to provide a solution. Read More
The market for multinational medical device companies in China has largely been driven by use only in major public hospitals for patients who pay mostly or entirely out-of-pocket. But that’s continuing to change in ways that could offer a window onto medical device trends in the region over the coming decades. Read More
HONG KONG – Singapore molecular diagnostics group Inex Innovate Pte. Ltd. has inked a deal to have its in-vitro diagnostic (IVD) kit for the detection of ovarian cancer distributed in Taiwan. The value of the deal with the New Taipei City, Taiwan-based electronics and med-tech distributor Inalways Corp. is subject to annual minimum order quantities and milestones in relation to regulatory approvals. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ancora Heart, Avra Medical Robotics, Cypris Medica, Cvrx, Quest Diagnostics, Siemens Healthineers, Trimedx, Cybervista. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medalliance. Read More
Keeping you up to date on recent developments in cardiology, including: Long QT genes mostly short on evidence; Cerebrospinal fluid is early culprit in stroke edema; Regenerative HBOT protocols appear to improve cardiac function in healthy aging heart population; Blood test IDs risk of disease linked to stroke, dementia. Read More
