Du Pont's Neurolite is `approvable'
Du Pont Merck Pharmaceuticalsis poised to become the second company with a brain SPECT agenton the U.S. market. The Food and Drug Administration has sentDu Pont an "approvable" letter for Neurolite, its technetium-taggedbrain imaging agent.
Du Pont Merck Pharmaceuticalsis poised to become the second company with a brain SPECT agenton the U.S. market. The Food and Drug Administration has sentDu Pont an "approvable" letter for Neurolite, its technetium-taggedbrain imaging agent.
Neurolite is indicated for brain perfusion studies in strokepatients. An FDA advisory committee recommended Neurolite forapproval last year (SCAN 6/30/93). Final FDA approval will begiven upon mutual agreement of labeling and phase-four studies,according to the company. Neurolite has regulatory approval inJapan and several European countries.
Neurolite's arrival would double the number of commerciallyavailable brain SPECT agents in the U.S. Amersham's technetium-labeledCeretec is currently the only brain SPECT agent being activelymarketed.
Large Study Affirms Safety of Ultrasound Enhancing Agents for Echocardiography
May 16th 2025Those receiving ultrasound enhancing agents (UEAs) for transthoracic or stress echocardiography had lower odds of all-cause death in comparison to patients who did not have UEAs, according to a nationwide study involving 11.4 million patients.
BrightHeart Garners Third FDA Clearance for AI-Powered Assessments of Fetal Heart Ultrasound
May 14th 2025The latest FDA 510(k) clearance is for B-Right Views, an AI-enabled device, which provides automated detection of required views necessary for second- and third-trimester fetal heart ultrasound exams.
