FDA clears 5008X hemodialysis system from Fresenius Medical Care
February 8, 2024
Fresenius Medical Care announced today that it received FDA clearance for its 5008X hemodialysis system.
Fresenius Medical Care announced today that it received FDA clearance for its 5008X hemodialysis system.
ROSWELL, Ga., Feb. 6, 2024 /PRNewswire/ — StimLabs® announces FDA 510(k) clearance of Corplex P, the pioneering human umbilical cord-derived medical device. This first-of-its-kind clearance marks a significant milestone for the wound care industry and highlights StimLabs’ position at its forefront.
Boston Scientific (NYSE: BSX)+
announced today that the FDA approved an expanded indication for its WaveWriter spinal cord stimulation (SCS) systems.
Philips (NYSE: PHG)+
announced today that it received FDA 510(k) clearance for its latest IntelliVue patient monitor software.
Hologic (Nasdaq: HOLX)+
announced that the FDA granted clearance for its Genius digital diagnostics system with the Genius cervical AI algorithm.
The Evoque valve will serve patients with few treatment options, wrote RBC analyst Shagun Singh.
Philips (NYSE: PHG)+
announced today that the FDA granted 510(k) clearance to its latest TEE transducer technology.
Boston Scientific Corporation (NYSE: BSX) announced it has received U.S. Food and Drug Administration (FDA) approval for the FARAPULSE™ Pulsed Field Ablation (PFA) System. The FARAPULSE PFA System is indicated for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic, paroxysmal (i.e., intermittent) atrial fibrillation (AF) and is a unique new alternative to standard-of-care thermal ablation treatment.
With improvements to the stent graft delivery system enabling a 1 Fr profile reduction on the majority of sizes, the device now offers the most 6 Fr compatible configurations among balloon expandable stent grafts.
Magstim announced today that it received FDA clearance for its Horizon 3.0 transcranial magnetic stimulation (TMS) system with StimGuide Pro.