United States Food And Drug Administration
FDA clears first assay designed to measure lipoprotein(a) in nanomoles
Roche announced its next generation assay received FDA 510(k) clearance for the measurement of lipoprotein(a) for assessment of CV risk.
FDA clears novel at-home BP, pulse rate monitor
Withings Health Solutions announced its novel cellular BP monitor received FDA clearance to measure BP and pulse rate in adults with arm circumferences of 22 cm to 42 cm or 40 cm to 52 cm.
Heart pumps’ indication expanded to pediatric patients with HF, cardiogenic shock
Johnson & Johnson MedTech announced the FDA has approved an expanded indication and granted premarket approval for its heart pumps to be used to treat pediatric patients with symptomatic acute decompensated HF and cardiogenic shock.
Acoramidis approved to reduce CV death, hospitalization for cardiac amyloidosis
BridgeBio Pharma announced that acoramidis, its small molecule stabilizer of transthyretin, has been approved by the FDA for the reduction of CV death and hospitalization in patients with transthyretin amyloid cardiomyopathy.
Top in allergy/asthma: OFCs for children; inaccurate penicillin allergy labels delabeled
An expert at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting addressed the fear surrounding oral food challenges in infants and toddlers and discussed why they should not be deferred.
AI in cardiology: A call for robust validation, regulatory labeling and security of data
Editor’s Note: This is part two of a three-part Healio Exclusive series on the development and use of AI to improve clinical outcomes in cardiovascular medicine and considerations for regulatory labeling and patient privacy.
AI for detection of diastolic dysfunction gains FDA breakthrough device designation
Carelog announced its ECG-based algorithm received FDA breakthrough device designation for detection of diastolic dysfunction, an early predictor of HF with preserved ejection fraction.
FDA approves mapping, dual-energy catheter ablation system for persistent AF
Medtronic announced the FDA approval of its mapping and dual-energy catheter ablation system for the treatment of persistent atrial fibrillation and radiofrequency ablation of cavotricuspid isthmus-dependent atrial flutter.
FDA approves next-gen pulsed field ablation catheter for paroxysmal atrial fibrillation
Boston Scientific announced it received FDA approval for its navigation-enabled ablation catheter for the treatment of paroxysmal atrial fibrillation and 510(k) clearance for new imaging software for its pulsed field ablation system.
Speakers highlight 2024 regulatory moves in hypertension, lipid, diabetes therapies
There have been many recent regulatory updates in the areas of blood pressure management, dyslipidemia and diabetes management, speakers reported.