The final policy affirms coverage across CareDx’s transplant surveillance offerings in kidney, heart, and lung...
Syncron-E detects evidence of ineffective patient efforts in ventilated adults, creating a new FDA device category for ventilator waveform analysis software....
The LightningWire system is designed to support transseptal access in procedures such as atrial fibrillation ablation, left atrial appendage closure and transcatheter mitral interventions....
The company is preparing a dual FDA 510(k) and CLIA Waiver submission for its Flu A/B and RSV multiplex test on the Co-Dx PCR Pro platform....
AcuityMD surveyed 150 sales reps working across capital equipment and durable medical equipment (DME)...
The antibody has been selected by Abbott, Beckman-Coulter Diagnostics, Roche, Siemens Healthineers, Alamar Biosciences, Bio-Techne and Quanterix for the development of research and clinical pTau217 assays...
The LARS ACJ clearance gives the French orthopaedic company a first US regulatory milestone for its synthetic ligament platform....
The integrated catheter platform allows electrophysiologists to deliver radiofrequency and pulsed field energy through a single device....
The FDA-cleared bone conduction sound processor adds rechargeable use, improved sound processing and wider streaming options for hearing implant users....
Leqembi Iqlik is a first-of-its-kind anti-amyloid treatment worldwide, offering at-home dosing for initiation and maintenance...
