Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Gastro Concepts, Withings.
Labcorp Holdings Inc. launched its new H5N1 bird flu molecular test for humans in the U.S. as an international outbreak of the disease continues to spread in cows and poultry – and people. As BioWorld reported recently, just one mutation would make the flu variant highly transmissible in humans.
Promise Bio Ltd. emerged from stealth with $8.3 million in seed investment for its precision medicine platform, which addresses immune-mediated diseases.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Emission, Ginkgo Bioworks, Hyperfine, Illumina, Natera, Neogenomics, Ovation.io, Quanterix.
A gene therapy based on an enhanced lipid nanoparticle (LNP) loaded with vascular endothelial growth factor (VEGF) mRNA could be developed for the treatment of preeclampsia, according to a study in mice in which it alleviated maternal hypertension until the end of gestation and improved fetal health. Preeclampsia is a disease that affects 3% to 5% of pregnant women, who suffer from hypertension and proteinuria, elevated levels of protein in the urine, during pregnancy.
Heartbeam Inc. received U.S. FDA 510(K) clearance for its portable, non-invasive electrocardiogram system that enables on-the-go recording of heart signals. The cable-free, credit card-sized device uses five electrodes to capture signals from three directions and can be used whenever a patient feels symptoms, overcoming the challenge of identifying intermittent arrhythmias, which are often not experienced during scheduled appointments, without requiring patients to wear a device continuously.