相关临床试验
4
0 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
已完成
4
100.0%
暂无批准数据
- Daxor Corporation received FDA 510(k) clearance for its next-generation rapid, compact, hand-held Blood Volume Analyzer (BVA) that delivers results three times faster than its predecessor. - The device addresses volume derangement affecting millions of patients annually, including over seven million heart failure patients and 7.4 million critical care admissions requiring precise fluid management. - Peer-reviewed studies demonstrate BVA-guided care reduced heart failure one-year mortality by 86% and ICU mortality by 66% in septic/ARDS patients. - The lightweight 7-pound device enables broader clinical use across cardiology, nephrology, critical care, and emergency medicine settings where resources are limited.
- Daxor Corporation has submitted its next-generation blood volume analyzer (Daxor BVA) to the FDA for 510(k) clearance, designed to process tests three times faster than its predecessor. - The new device offers direct quantification of intravascular blood, red blood cell, and plasma volume while being completely portable and significantly simpler to operate at the point of care. - Developed under a U.S. Department of Defense contract, the technology aims to improve clinical workflows and patient outcomes through more accessible and accurate blood volume management.
- A new multicenter study across three major medical institutions demonstrates Daxor's Blood Volume Analysis (BVA) provides superior accuracy over conventional pressure-based measurements in heart failure patients. - Research published in the Journal of Cardiac Failure reveals BVA's unique ability to detect anemia and identify sex-specific volume differences, enabling more personalized treatment approaches. - The study, analyzing 255 heart failure patients, confirms BVA's 98% accuracy in volume assessment, highlighting its potential to improve patient outcomes through precise diagnosis.
