The FDA has issued an early alert involving certain Medtronic and Given Imaging Bravo CF esophageal pH capsule delivery devices after reports of 184 serious injuries linked to deployment failures that can lead to aspiration, perforation, airway obstruction and bleeding.
Revolution Medicines has secured FDA approval for Rasonque, or daraxonrasib, after a 500-patient Phase 3 trial showed median survival of 13.2 months compared with 6.7 months on chemotherapy in previously treated metastatic pancreatic cancer.
The FDA has approved Eli Lilly and Company’s Mounjaro to reduce cardiovascular death, heart attack and stroke risk in high-risk adults with type 2 diabetes, significantly broadening the clinical case for tirzepatide beyond glucose control and weight reduction.
BEACONPredict and a growing body of research are testing whether artificial intelligence can use routine CT imaging to predict malignant cerebral edema before neurological deterioration, potentially shifting stroke care from emergency reaction toward preventive intervention.
Avulux has received FDA De Novo authorization for an over-the-counter precision optical filter that selectively blocks wavelengths associated with migraine-related light sensitivity while allowing much of the remaining visible spectrum through.
Roche has secured FDA clearance for Elecsys pTau217, a single-biomarker blood test capable of supporting both rule-in and rule-out assessment of Alzheimer’s-associated amyloid pathology across primary and specialty care.
The U.S. Food and Drug Administration has approved once-weekly MIMRYLO, or rusfertide, for erythrocytosis in adults with polycythemia vera, introducing the first therapy designed to mimic the iron-regulating hormone hepcidin.
Tenax Therapeutics has presented a deeper analysis of its Phase 3 LEVEL trial showing substantially stronger TNX-103 effects in PH-HFpEF patients with poorer baseline exercise capacity, giving the company a potential enrichment strategy for its ongoing LEVEL-2 registrational program despite LEVEL missing its primary endpoint.
A new Philips and Imricor interventional MRI platform brings cardiac procedures inside a 1.5-tesla MRI environment, advancing a longer-term effort to replace indirect X-ray guidance with direct tissue visualization.
Roche has secured expanded FDA approval for two HER2 companion diagnostics used to identify gastroesophageal adenocarcinoma patients who may be eligible for Jazz Pharmaceuticals’ ZIIHERA.