Diabeloop wins FDA nod for new automated insulin delivery algorithm
December 22, 2025
Diabeloop announced today that its DBLG2 algorithm for automated insulin delivery has received FDA 510(k) clearanc
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.
Medtronic (NYSE: MDT)+
and Johnson & Johnson (NYSE: JNJ)+
have both announced recent regulatory milestones for liquid embolic systems.
CMR gained FDA marketing authorization for its first-generation Versius robot in October 2024 through the de novo pathway. In April, the company said it raised more than $200 million to support the commercialization of Versius.