The U.S. FDA expanded the approval for use of Boston Scientific Corp.’s Watchman Flx and Watchman Flx Pro left atrial appendage closure (LAAC) devices to include post-ablation patients, bringing good news to the company as it preps for its second quarter earnings report on July 23. Read More
Directsens GmbH recently signed a collaboration agreement with Metage, an Austrian research consortium, to advance a test for the early detection of type 2 diabetes. The focus of the partnership will be on validating Directsens’ Xpressgt assay, which measures 2-hydroxybutyrate levels in venous blood, and could be used by clinicians to inform patients they are at risk of developing type 2 diabetes. Read More
Globus Medical Inc. reported the departure of its president and CEO, but sought to quell any concerns about what his leaving augurs for the future of the company. Read More
Australia’s Therapeutic Goods Administration proposed to adopt a 2021 EU guideline on quality documentation for drugs used with medical devices including co-packaged products, a demonstration of the impact of EU regulations on Australia’s own regulatory approach. Read More
Palmetto GBA of Columbia, S.C., issued a draft local coverage determination that provides coverage for biomarker testing to stratify a patient’s risk associated with ductal carcinoma in situ. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Fluoguide, Olympus, Prophase, Radiology Oncology Systems, Raysearch, Zimvie. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Medtronic, Seimens, Spirair, Takeda. Read More
