There is a belief among some clinicians that it is too easy for companies to gain CE mark approval for their medical devices. However, a new proposal from the European Society of Cardiology and other groups could help change that.
The FDA is warning the public that certain Medline surgical kits may contain catheters that have been linked to 41 customer complaints and three serious injuries.
The Urology Management Alliance is teaming with IR Centers, a platform company dedicated to offering minimally invasive procedures in outpatient settings.
Syracuse, New York-based Upstate Medical University had previously relied on rad residents to handle initial reads, with attendings finalizing interpretation in the a.m.
“FDA clearance comes at the perfect time, with guidelines being adopted clinically for cardiac CT and with positive reimbursement driving procedure growth," says Jean-Luc Procaccini, CEO, molecular imaging and CT.
It is the only integrated system that combines high-density mapping and PFA in a single device. The system uses a 122-electrode spherical array to enable rapid, single-shot pulmonary vein isolation, helping to streamline workflows.
Toby Rogers, MD, associate professor of medicine at Georgetown University and an interventional cardiologist at MedStar, explains how electrosurgical procedures for transcaval access have helped large numbers of patients receive transcatheter heart valves who otherwise would have been disqualified due to anatomical issues.
AI could appreciably improve the delivery of healthcare services to patients—if only people trusted it. For many, the difference-maker would be nicely crafted federal regulations.
There is a belief among some clinicians that it is too easy for companies to gain CE mark approval for their medical devices. However, a new proposal from the European Society of Cardiology and other groups could help change that.
