Nipro’s newly FDA-cleared ELISIO-HX is designed to remove larger uremic middle molecules while retaining essential proteins and working with existing hemodialysis infrastructure.
Wellspect has launched a suction-based urine collection system for home use in the United States, completing a Surity portfolio built around female and male external catheters rather than indwelling drainage.
Pulnovo has treated the first two US patients in PULSE-LHD, a randomized 750-patient IDE study testing whether pulmonary artery denervation can reduce major heart-failure events in combined pre- and post-capillary pulmonary hypertension.
Cutiva PLUS has completed its first patient cases after Resivant scaled its crosslinked silicone-cyanoacrylate adhesive, moving a 2024-cleared wound-closure system toward broader commercial use.
West Cancer Center has received IRB approval to join IceCure’s 400-patient ChoICE post-market study of ProSense in women aged 70 and older with small, biologically low-risk breast cancers.
FIND Neuro’s CN-Suite analyzes intracranial EEG to rank seizure-driving brain regions, giving epilepsy teams quantitative decision support during presurgical evaluation for patients aged three and older.
Avricore Health’s HealthTab will distribute Abbott’s Afinion 2 through NHS-linked pharmacies, combining rapid HbA1c and lipid testing with a connected platform for community-based screening.
FDA cleared Cubresa BrainPET as a Class II PET-MR imaging system, allowing the removable brain-dedicated PET insert to be used with compatible Siemens infrastructure.
FDA has updated TearCare’s indication to state that the system improves meibomian gland function when thermal treatment is combined with manual gland expression.
FDA has agreed to Femasys’ modular PMA approach for FemBloc, allowing manufacturing and nonclinical portions to be reviewed before the pivotal FINALE pregnancy data are complete.