BioControl Becomes Latest Company To Report Disappointing Outcomes With VNS Therapy For Heart Failure
BioControl Medical has terminated the INOVATE HF trial of its CardioFit vagus nerve stimulator (VNS) for the treatment of heart failure after a pre-specified interim analysis showed the trial had little chance of meeting its primary endpoint. Despite the disappointing results, some physicians remain optimistic about VNS for heart failure and researchers continue to analyze patient subgroups and secondary endpoints to identify potential patients who might benefit from VNS therapy.
In this week's Digital Health Roundup, MedTech Insight's Shubham Singh explores how Ketryx's launch of validated AI agents could reshape compliance automation in medtech. Marion Webb highlights news from BCI makers Synchron, Axoft and Subsense. Elizabeth Orr discusses AI advances at the FDA.
Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.
Abbott received the US FDA nod for its Tendyne system, offering a minimally invasive alternative to replace the valves of patients with severe mitral valve disease who are at risk for open-heart surgery.
Cardiosense has launched a nationwide clinical study, SEISMIC-HF II, to validate its non-invasive, AI-powered technology for monitoring heart failure. The data will be used to file for US regulatory clearance of the Cardiosense heart failure monitoring platform.
Allen Burton, Abbott’s medical director of neuromodulation told Medtech Insight that the delivery system was developed to make the procedure easier for physicians, especially those who perform the implantations infrequently.
In this week's Digital Health Roundup, MedTech Insight's Shubham Singh explores how Ketryx's launch of validated AI agents could reshape compliance automation in medtech. Marion Webb highlights news from BCI makers Synchron, Axoft and Subsense. Elizabeth Orr discusses AI advances at the FDA.
Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.
