Phase Scientific International Ltd. launched China’s largest clinical study for urine-based cervical cancer screening. If successful, the blood-based test could be the first non-invasive test for HPV.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aclarion, Arecor, Apiject Systems, Cnside Diagnostics , Elitechgroup, Femtoinnovations, Fronteracare , Plus Therapeutics, Sequel Med Tech, Hitachi High-Tech, Rapidemic, Tescan Group.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cardiac Biotech, Clearnote Health, Heamosonics, Marginum, Mediwound, Zimmer Biomet.
Rakuten Medical Inc. is advancing a pipeline of solid tumor therapeutics built on its Alluminox platform worldwide, having gained conditional early approval of ASP-1929, an Alluminox-derived photoimmunotherapy, in Japan in 2020.
About five months after the U.S. FDA disclosed its roadmap to move away from animal testing in favor of new approaches for biopharma drug development, the U.S. National Institutes of Health (NIH) said it is awarding $87 million in contracts over three years to launch the Standardized Organoid Modeling Center.
The Trump administration has launched an investigation into the national security effects of imports of medical equipment, devices, consumables and equipment, laying the groundwork for a potential increase in tariffs targeting the industry. A separate investigation into robotics and industrial machinery began the same day. Med-tech stocks dropped significantly in response to the news as investors fear increased tariffs on the sector. In April, the administration initiated a similar review of the pharmaceutical industry and in August threatened 200% tariffs on that sector.
The U.S. FDA issued a pair of final guidances this week, including one that outlines the criteria for authorizing emergency use of unapproved in vitro diagnostic tests during future public health emergencies and another on software assurance in computer and data processing systems for medical device production.
RSS
