Cardiac Pathways submits Tracking system to FDA:
This article was originally published in Clinica
Executive Summary
Cardiac Pathways has filed a 510(k) application with the US FDA to market a range of products based on its Tracking System technology. The system can help visualise the position of multiple electrophysiology catheters in the heart simultaneously, in three-dimensions and in real-time without the aid of fluoroscopy. It consists of a line of diagnostic catheters, which contain ultrasound transducers that triangulate, in real-time, their position within the heart, and a computer system that combines real-time, three-dimensional graphics, displaying catheter images while recording the associated intracardiac electrical signals, said the Sunnyvale, California-based company.
You may also be interested in...
Fenty Cleanser Performance Claims Supported, But Influencer Videos Need Disclaimers – NAD
A National Advertising Division review of claims by LVMH-owned Fenty Skin determined makeup- and dirt-removal representations were substantiated by a study and subject questionnaire, but demo videos from paid endorsers must include disclosures about material connections in accordance with FTC guidelines.
Clinical Trial Diversity Requires Sponsors Work With An Assortment Of Patient Advocates, Community Organizations
US FDA oncology officials are concerned that the entities sponsors are consulting in developing and implementing clinical trial diversity plans are not sufficiently diverse themselves and do not represent patients in underserved communities.
Israeli Company Lands De Novo Clearance For Digital Bone Marrow Application
The US FDA has cleared a novel software application to enhance the analysis of bone marrow smears. Using the AI-powered tool, hematopathologists may be able to better diagnose various blood and marrow diseases.