Boston Scientific is removing all Imager II angiographic catheters from use after discovering that reduced stabilizing agents in catheter tips could increase degradation and detachment risk, while the medtech company simultaneously works through a separate global cyber disruption.
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.
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.
Generative artificial intelligence is pushing medical software beyond fixed predictions toward systems capable of conversation, synthesis and potentially autonomous actions. The FDA is now exploring whether these devices should be evaluated more like clinical professionals than conventional software.
Tempus AI has received FDA 510(k) clearance for ECG-PH, artificial-intelligence software that analyzes routine 12-lead electrocardiograms for signs associated with elevated pulmonary artery pressure in symptomatic adults without a known pulmonary-hypertension diagnosis.
Abbott Laboratories has secured FDA De Novo authorization for Libre Duo 10 Day, the first wearable in the United States to continuously monitor ketones and the first device globally to continuously measure glucose and ketones together.
The U.S. Food and Drug Administration has approved Priovant Therapeutics’ LISRAYA, or brepocitinib, for adults with dermatomyositis, creating the first FDA-approved oral treatment for the rare systemic autoimmune disease. The decision converts positive Phase 3 VALOR data into Roivant Sciences’ first commercial opportunity for a drug that is also being developed across several other immune-mediated
Johnson & Johnson has secured FDA approval for IMAAVY in warm autoimmune hemolytic anemia, giving eligible patients aged 12 and older the first treatment specifically approved in the United States for wAIHA.