Cardiac Imaging
Noninvasive CAD staging system receives FDA breakthrough device designation
Cleerly has received FDA breakthrough device designation for its coronary artery disease staging system, which was also accepted into the FDA’s Total Product Life Cycle Advisory Program Pilot, according to a company press release.
FDA approves cardiac ultrasound enhancing agent for pediatric patients
Lantheus Holdings announced the FDA has approved the supplemental new drug application for its perflutren lipid microsphere injection to improve ultrasound imaging in pediatric patients with suboptimal echocardiograms.
Miniaturized transesophageal echocardiography transducer gains FDA 510(k) clearance
Philips announced it received FDA 510(k) clearance of its next-generation, miniaturized, transesophageal echocardiography transducer which can be used in very small patients and complex ICU cases.
Intravascular imaging-guided PCI shows benefit for left main CAD vs. angiography
Intravascular imaging-guided PCI showed benefit vs. angiography for patients with left main CAD, with significantly lower risk for cardiac death or spontaneous target vessel-related MI, researchers reported.
AI-enabled technology independently predicts cardiac events based on coronary inflammation
PHILADELPHIA — An artificial intelligence-based technology that evaluates coronary inflammation predicted risk for cardiac events in patients undergoing coronary CTA, according to new study data.
FDA clears next-generation image system to guide cardiac interventions
GE HealthCare announced it received FDA 510(k) clearance of its next-generation image-guided system, designed to optimize imaging at the right dose regardless of patient size, for use during interventional CV procedures.
Use imaging, interventional testing to help discern ischemia with nonobstructive CAD
Women presenting with chest pain but without signs of obstructive coronary disease may still have microvascular dysfunction, and careful imaging analyses or invasive testing can help reveal the correct diagnosis, according to a speaker.
FDA clears next-generation cardiovascular, thoracic CT scanners
Arineta Cardio Imaging announced the FDA 510(k) clearance and launch of its next generation cardiovascular CT scanners.
Ability to detect CAD confirmed for PET with novel radiotracer
Confirming a previous report, PET with a novel radiotracer had good sensitivity and specificity for CAD detection and outperformed single-photon emission CT myocardial perfusion imaging.
PET scan-guided program superior to standard care in patients with suspected CAD
A comprehensive strategy involving shared cardiac PET scans was associated with better CV outcomes compared with standard care in patients with suspected CAD, according to the results of the CENTURY trial.