Baxter International Inc.’s fourth quarter earnings per share came in well below consensus and the company lowered expectations for 2023’s first quarter and full-year performance citing “ongoing macroeconomic challenges and supply chain headwinds.” Topline results that beat expectations provided cold comfort to investors who saw the stock price drop 12% following the release of the quarterly report. Baxter also provided additional details on the restructuring including limited layoffs along with the quarterly update. Read More
The U.S. FDA has cleared the way for Seastar Medical Holding Corp.. to conduct a pivotal IDE study of its Selective Cytopheretic Device (SCD) in adults with acute kidney injury (AKI). The Denver-based company plans to begin enrolling patients as early as next month. Read More
Anteris Technologies Ltd. raised AU$35 million (US$24.21 million) to fund clinical development of its 3D single-piece prosthetic heart valve implant, the Duravr, for the treatment of aortic stenosis. Read More
Reflexion Medical Inc. has been granted U.S. FDA marketing clearance for biology-guided radiotherapy to treat early and late-stage cancers. An expansion of the company’s existing X1 platform, Scintix is indicated for patients with lung and bone tumors which may arise from primary cancers or from metastatic lesions spread from other cancers in the body. Read More
It may still be true that a majority of medical devices are manufactured in the U.S., but that doesn’t stop the FDA from dropping a warning letter on facilities located outside the U.S. (OUS). In one of these warning letters, Microvention Inc., of Aliso Viejo, Calif., received a warning letter for its plant in Costa Rica, although the FDA waited until the second week of February to post the Sept. 30, 2022, warning. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Brainbox Solutions, Intelligent Bio Solutions, Meditrial Europe, Syntach, Vaxxas. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Catalyst Orthoscience. Read More
