MannKind earns FDA nod for on-body infusor, new autoinjector patents
December 23, 2025
MannKind (Nasdaq:MNKD) announced today that the FDA approved its Furoscix (furosemide) on-body infusor for pediatric patients.
MannKind (Nasdaq:MNKD) announced today that the FDA approved its Furoscix (furosemide) on-body infusor for pediatric patients.
Edwards Lifesciences (NYSE: EW)+
has won FDA approval for its Sapien M3 mitral valve replacement system for treating mitral regurgitation (MR).
Diabeloop announced today that its DBLG2 algorithm for automated insulin delivery has received FDA 510(k) clearanc
Stifel analysts said the label for cardiac myosin inhibitor Myqorzo is in line with their expectations and is differentiated compared with BMS’ Camzyos.
Abbott (NYSE: ABT)+
announced today that the FDA approved its Volt pulsed field ablation (PFA) system to treat patients with AFib.
The next evolution of truFlex fortifies its position as a versatile solution for rehabilitation with new applications in functional strength for the abdomen, arms, calves, glutes and thighs.
The Accuro 3S Needle Guide Kit, designed for use with the Accuro 3S ultrasound imaging system and Dual-Array transducer, includes single-use, sterile components that support infection control and promote workflow efficiency
The KPAP sleep therapy platform is developed to offer an adaptive and patient-focused alternative to traditional CPAP therapy
Pulse Biosciences (Nasdaq:PLSE) announced today that the FDA granted investigational device exemption (IDE) for a pulsed field ablation (PFA) study.
Abbott (NYSE: ABT)+
announced today that it received FDA clearance for its Amplatzer Piccolo delivery system for use with the Amplatzer Piccolo Occluder.