Medical technology company Cardiologs reported on Monday the receipt of US Food and Drug Administration (FDA) 510(k) clearance for its AI-powered cardiac diagnostics platform for paediatric cardiology based on an analysis of its improved deep learning algorithm.
Based on 20 million EKG recordings, the company used the new model to evaluate a global sample of 10,000 EKG readings from patients in various age groups. The updated algorithm improved average sensitivity over all major arrhythmias by 14% while reducing the number of false positives by 48%.
The company added that the new data shows improved deep learning algorithm performs equally across all age groups, enabling more patients to benefit from the company's cardiac diagnostics AI platform.
A policy statement published online recommended that all children be screened for the risk of sudden cardiac arrest (CA) or sudden cardiac death (SCD) at a minimum every three years. An increasing number of physicians are combining clinical expertise with AI-assisted analysis to improve detection for children and teens with abnormal heart rhythms, which can lead to earlier intervention and better outcomes.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval