blood clots
Akonni Bio Obtains FDA 510(k) Clearance for TruDiagnosis MDx System, PGx Test
Akonni has received clearance for a molecular diagnostic instrument and a saliva-based pharmacogenomics test for warfarin metabolism.
Abbott's iStat Comes Out on Top in Study Comparing Blood Clot Monitoring Tests
After conducting a head-to-head comparison with competing instruments, clinicians selected the Abbott iStat instrument to monitor blood clotting during surgical interventions.
Anticoagulant Therapy Partnership Forged by CoaguSense, PCDS
The partnership is directed at streamlining the healthcare workflow and improve decision-making by clinicians and patients related to anticoagulant therapy.
Warfarin Monitoring Device From CoaguSense Cleared by FDA
The FDA cleared the firm's Coag-Sense PT2 second-generation PT/INR monitoring system for professional use in a CLIA setting and by patients at home.
FDA Classifies Recall of Blood Thinner Monitoring Tests as Class I
The FDA said that Terrific Care/Medex Supply distributed certain Roche Diagnostics test strip lots in the US even though domestic sales had been stopped due to safety concerns.