Fitbit in obtaining 510(k) clearance for a smartwatch-based atrial fibrillation detection application.
CuraCloud in obtaining 510(k) clearance for CuraRad-ICH, an AI-based CT-imaging triage software for intracranial hemorrhage.
Caption Health (formerly Bay Labs) in obtaining De Novo marketing authorization for the innovative Caption Guidance, which uses artificial intelligence to provide real-time guidance and diagnostic quality assessment during acquisition of echocardiography, empowering healthcare providers—even those without prior ultrasound experience—with the ability to capture diagnostic quality images. Also in seeking 510(k) clearance for its EchoMD AutoEF software, which applies machine learning algorithms to process echocardiography images in order to calculate left ventricular ejection fraction.
Eko in obtaining 510(k) clearance for a suite of machine learning and signal processing algorithms designed to provide clinical decision support to physicians during the evaluation of cardiac data, and in obtaining Breakthrough Device designation for a novel ECG-based algorithm.
IDx LLC in obtaining De Novo reclassification from the FDA for the groundbreaking AI-based IDx-DR, which autonomously analyzes images of the retina for signs of diabetic retinopathy.
Biobeat in obtaining 510(k) clearance for the company’s noninvasive multiparameter wearable sensor (pulse rate, blood oxygen saturation and changes in blood pressure).
Exact Sciences in obtaining FDA approval for Cologuard, the first noninvasive sDNA screening test for colorectal cancer that analyzes both stool DNA and blood biomarkers.