Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Andor Health, Bruker, Deep 6 AI, Detect-Ion, Elitechgroup, Efertility, Intuity Medical, Magnolia Market Access, Nuvo, Valencia Technologies, Vitrolife.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Briohealth Solutions, Owlet, United Imaging.
Just a few days after the U.S. Congressional Research Service issued a report suggesting ways Congress could resolve the unanswered questions about patent listings in the FDA’s Orange Book, the FTC sent a second round of warning letters to eight biopharma companies and their subsidiaries, citing the listing of device patents for combination products.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: GT Medical, Limbus AI, Magventure, Magnus Medical, Pavmed, Radformation, Retispec, Theragenics, Topcon Healthcare, Verantos, Veris.
The U.S. FDA issued a handful of warning letters to device makers in the month of April 2024, one of which is for the Waukegan, Il., plant operated by Cardinal Health Inc., of Dublin, Ohio. While the Waukegan plant escaped citations for most routine Quality System Regulation deviations, the FDA said Cardinal’s handling of contract manufactured luer locks and syringes fell well short of the agency’s expectations given that these issues led to a massive recall, a product removal and an FDA advisory.
RSS
