Combining Sarepta Therapeutics Inc.’s gene editing technology and Genedit Inc.’s Nanogalaxy platform to treat neuromuscular disorders shows promising potential, the companies reported. A year into the research collaboration, Genedit’s polymer nanoparticles have demonstrated the ability to deliver therapeutic cargo to specific muscle tissue following system administration of targeted genetic medicines. Read More
San Francisco-based startup Mirvie Inc. has released data demonstrating how its RNA platform technology can predict preterm birth. The research, presented at the Society for Maternal-Fetal Medicine 42nd Annual Pregnancy Meeting (SMFM 2022), showed the company’s test predicted the condition months before symptoms occurred and identified biological pathways that drive changes in pregnancy. Read More
The pivotal, multicenter trial commissioned by Envveno Medical Corp. is intended to show its first-in-class Venovalve implant is safe and effective for treating deep venous chronic venous insufficiency (CVI), which occurs when damaged valves inside the veins of the leg prevent blood from flowing up the leg and into the heart and lungs. Read More
PARIS – An interdisciplinary academic research consortium in Italy has devised and tested nanowires that restore physiological cell-to-cell conductance. This research team, led by the Experimental and Applied Medical Technology Lab (Tecmed Lab) at the Department of Medicine and Surgery at the University of Parma, Italy, has just published the results of multiple local in situ injections of nanowires into left ventricular infarct regions in Nature Communications. Read More
The guidances for in vitro diagnostics (IVDs) developed by the European Union’s Medical Device Coordination Group (MDCG) are only a reflection of the In Vitro Diagnostic Regulation (IVDR), but they do provide test developers with some important details. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Know Labs, Medidata Solutions, Parexel, Proscia. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ambu. Read More
