Lindis Blood Care GmbH recently revealed excellent data from the Remove study that showed that its Catuvab device was safe and effective in removing tumor cells from intraoperative blood during high blood loss cancer surgeries.
The U.S. Federal Trade Commission (FTC) finalized its overhaul of the health breach notification rule (HBNR), significantly expanding the types of software products subject to the agency’s oversight. However, the final rule was approved by the commission by a narrow 3-2 vote and was the subject of a scathing critique by the two dissenting commissioners, who argued that the FTC has once again exceeded its statutory authority in rewriting the HBNR.
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.
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