Evinova and Lothar Medical will integrate a three-in-one pulmonary assessment device with a clinical-trial platform already used at more than 4,000 sites in 54 countries.
Texas Cardiac Arrhythmia Institute has performed the first U.S. procedure in Boston Scientific’s 571-patient FARAFLEX pivotal program evaluating integrated mapping and pulsed field ablation for paroxysmal and persistent AF.
Interim MASTRR Registry results across 10 U.S. centers found no adverse events definitely related to Aroa’s Myriad products and low infection rates despite a highly complex wound population.
Sky Labs reports new ESC 2026 data supporting ring-based 24-hour blood pressure monitoring in atrial fibrillation and severe heart failure, as CART BP pro expands beyond conventional cuff monitoring.
HoneyNaps has developed a four-patch wireless polysomnography platform capturing EEG, EOG, ECG, EMG, airflow and oxygen data while connecting with its FDA-cleared SOMNUM AI software.
A 120-patient multicenter study of the FDA-cleared SinglePass Kronos biopsy-tract electrocautery device reported 100% technical success and no clinically significant bleeding through 30 days.
Pulnovo’s randomized PADN-HF-PH study found a 51% reduction in clinical worsening with pulmonary artery denervation plus medical therapy, with results published in NEJM.
A 587-patient matched real-world analysis found severe bleeding in 21.8% of CytoSorb-treated urgent CABG patients versus 34.5% of controls, strengthening CytoSorbents’ planned DrugSorb-ATR De Novo resubmission.
Medibyt has received FDA 510(k) clearance for CPETWise, a software platform designed to standardize cardiopulmonary exercise test analysis while preserving clinician access to underlying physiological data.
Withings is launching StethO Sense for BeamO, combining FDA-cleared eMurmur heart-sound AI with a separate U.S. wellness breathing index from StethoMe.