From the August 2016 issue of HealthCare Business News magazine
MR-Conditional
Pacing System
MR-Conditional Pacing System
Boston Scientific has received FDA approval for a suite of products deemed safe for use in an MRI environment. The ImageReady MR-Conditional Pacing System, which includes ACCOLADE MRI and ESSENTIO MRI pacemakers, as well as the new INGEVITY MRI pacing leads, is designed to treat bradycardia. Patients implanted with the full system are able to receive full-body MR scans in 1.5 Tesla environments when conditions of use are met. The newly approved family of INGEVITY MRI pacing leads includes active and passive fixation models. This marks the first time a passive fixation pacing lead is approved for U.S. patients undergoing MR scans.
Single-Chamber ICDs for
Detecting Atrial Fibrillation
Single-Chamber ICDs for Detecting Atrial Fibrillation
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Medtronic announced it has received FDA approval for the Visia AF MRI SureScan and Visia AF single-chamber implantable cardioverter defibrillators. The Visia AF devices can detect previously undiagnosed and/or asymptomatic atrial fibrillation and monitor recurrent AF, while treating life-threatening rhythms in the lower chambers of the heart.. The Visia AF ICDs include a proprietary algorithm that detects AF episodes (without a lead in the atrium) and captures AF frequency and duration, information that helps physicians identify AF and tailor treatment for these patients. More than half of all new ICD implants in the U.S. are single-chamber devices.
Radixact System
Accuray Incorporated has received 510(k) clearance for its Radixact™ Treatment Delivery Platform and its new treatment planning and data management systems, Accuray Precision Treatment Planning System and iDMS Data Management System. These next generation hardware and software solutions, together, make up the new Radixact system. The system features a more powerful linear accelerator, MVCT imaging and helical treatment delivery, so clinicians can apply highly conformal and homogenous dose distributions to any target volume, while precisely sparing normal healthy tissue during each treatment fraction. The new Accuray Precision Treatment Planning System with smart, automated workflows and midcourse decision-making tools enables clinicians to adapt delivery to changes in tumor size, shape and location within the patient.
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