MedTech News
.................... by Andrew Celentano
Edwards wins FDA approval for Sapien M3 mitral valve, marking first transseptal transcatheter therapy
Edwards Lifesciences (NYSE: EW)+
has won FDA approval for its Sapien M3 mitral valve replacement system for treating mitral regurgitation (MR).
Shape Memory Medical’s embolisation plugs gain CE mark under EU MDR
Shape Memory Medical’s IMPEDE embolisation plug range has received CE mark as a Class III device under the European Union’s Medical Device Regulation (EU MDR).
Monoclonal antibody shows promising results for rare liver disease
A multicenter study led by UC Davis Health has tested a new treatment designed to improve care for people with a rare liver disease called primary sclerosing cholangitis. Researchers learned that an anti-inflammatory and anti-fibrotic monoclonal antibody known as nebokitug was safe and showed potential efficacy in patients with PSC.
Scientists grow mini brains to uncover cells behind autism-related brain overgrowth
A new study in the lab of Jason Stein, Ph.D., modeled brain development in a dish to identify cells and genes that influence infant brain growth, a trait associated with autism.
Diabeloop wins FDA nod for new automated insulin delivery algorithm
Diabeloop announced today that its DBLG2 algorithm for automated insulin delivery has received FDA 510(k) clearanc
Cytokinetics Wins FDA Approval, Clearing Way to Challenge BMS in Heart Disease Market
Stifel analysts said the label for cardiac myosin inhibitor Myqorzo is in line with their expectations and is differentiated compared with BMS’ Camzyos.
Abbott earns FDA approval for Volt PFA system for AFib
Abbott (NYSE: ABT)+
announced today that the FDA approved its Volt pulsed field ablation (PFA) system to treat patients with AFib.
Scientists build virtual tissue tools to map how cells talk in disease
Scientists at Duke-NUS Medical School have developed two powerful computational tools that could transform how researchers study the “conversations” between cells inside the body. The tools, called sCCIgen and QuadST, help scientists understand both where cells are located in tissues and how they communicate through genetic activity and chemical signals.