Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Diality, Thermo Fisher Scientific.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Daxor, Infusystem, Luminopia, Medaxiom, Smith & Nephew, Vascular Therapies, Zywie.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Tuesday Health, Lunit, Molculight, SPR Therapeutics.
In what represents just the second PCT filing to have emerged from Valar Labs Inc., the company’s co-founders – Joshi Anirudh, Viswesh Krishna, and Damir Vrabac – describe their development of an AI-derived histologic signature for predicting patient outcomes to treatments for pancreatic cancer.
The European Medicines Agency seems focused on pharmaceuticals to the near exclusion of medical technology, but the agency recently reported the launch of a pilot program for orphan medical devices.
Lest there’s any confusion, Lucid Diagnostics Inc. published promising results from a third study showing the benefit of its non-invasive Esoguard test for detecting esophageal cancer and precancer conditions.
U.S. federal enforcement authorities rang up some significant settlements under the False Claims Act in the first half of 2024, amounting to a record $1 billion in total settlements, according to a report by the law firm of Gibson, Dunn & Crutcher LLP.
Haemonetics Corp. received CE mark certification for the Savvywire pre-shaped pressure guidewire, a sensor-guided three-in-one guidewire for transcatheter aortic valve implantation. The solution, which is expected to enhance TAVI procedures and improve patient outcomes, is already being used in procedures in European countries.
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