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.
ENRICH recorded HBsAg loss rates of 42.9% and 40% after BRII-179 priming, while a concurrent triple regimen underperformed expectations and a recalled assay kit now requires retesting of another cohort.
FDA Fast Track gives Rein Therapeutics closer regulatory access as its 120-patient RENEW trial tests whether inhaled LTI-03 can translate promising biomarker effects into measurable preservation of lung function.
FDA is exploring competency assessment, risk-based monitoring and new lifecycle controls for generative AI medical devices whose outputs can vary by prompt, context and software evolution.
Bispecific T-cell engagers developed for blood cancers are being repurposed to eliminate pathogenic B cells and plasma cells in severe autoimmune disease, potentially offering CAR-T-like depth without individualized cell manufacturing.
ReVeRA-301 will test self-administered etripamil in about 150 patients, using ventricular-rate reduction within 30 minutes as the primary endpoint and the same regimen already approved for PSVT.
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.
Orum plans an approximately 42-patient Phase 1 study of ORM-1153 after FDA cleared the CD123-targeting conjugate to deliver a GSPT1 protein degrader into AML cells.
Pathology foundation models learn reusable representations from millions of tissue images and can be adapted for cancer detection, biomarkers and prognosis, potentially replacing one-algorithm-per-task development.
Blood tests measuring phosphorylated tau and amyloid-related biomarkers can identify Alzheimer’s-associated brain pathology with high accuracy, but they are not interchangeable with population screening or a complete dementia diagnosis.