Tandem Diabetes Care Inc. entered a definitive agreement to acquire AMF Medical SA for CHF 62.4 million (US$67.1 million) in cash at closing plus future payments of as much as CHF 129.6 million (US$139.43 million) contingent on meeting certain milestones. Tandem also invested CHF 8 million (US$8.6 million) in AMF in the third quarter of 2022. The transaction is expected to close in January 2023. Read More
The European Commission has given in to the increasing pressure and alarm from member states and is moving to extend the deadlines for implementing the 2017 Medical Device Regulation (MDR) and the In Vitro Devices Regulation (IVDR). Read More
The U.S. FDA’s use of remote regulatory assessments (RRAs) during the pandemic may have been inevitable, but a proposed continuation of the program in the endemic phase of the SARS-CoV-2 contagion hasn’t necessarily won over device manufacturers. Read More
Even though Cytokinetics Inc. received applause for testing its heart failure drug, omecamtiv mecarbil, in the second largest global heart disease clinical trial ever, the drug didn’t get a standing ovation from the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) Dec. 13. Read More
Ovarian cancer is ordinarily associated with poor survival; patients diagnosed with high-grade serous ovarian carcinoma (HGSC) have an overall survival of about 40% at 5 years and 15% at 10 years. Despite having similar histologic features, HGSC patients often experience highly variable outcomes and the underlying determinants for long-term survival (LTS) are largely unknown. In a study published online in Nature Genetics, a multi-institutional group of researchers tried to determine the molecular differences that drive LTS in patients with HGSC. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allay Therapeutics, Behavr, Cardionxt, Eargo, Evonik, Field Medical, Iterative Health, Nanovibronix, Orbusneich, Oxford VR, Peak Medical, QT Imaging. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agilent, Axonics, Eyenovia, Mediwound, Qiagen. Read More
