Tag: Radiology

New CNS Drug Delivery System by Alcyone Lifesciences Given Breakthrough Designation by FDA

Alcyone Lifesciences recently obtained Breakthrough Device Designation from the FDA for their novel implantable intrathecal bolus drug delivery catheter and port system, the ThecaFlex DRx System. The system is intended for use in conditions that require prolonged medication administration directly into the cerebrospinal fluid (CSF), such as some ca (Read more...)

Phillips Azurion with FlexArm for Enhanced Image-Guided Therapy: Interview with Dr. Barry Katzen of Miami Cardiac and Vascular Institute

Phillips recently announced the release of an enhancement to its Azurion imaging system – the FlexArm. Developed in partnership with the Miami Cardiac & Vascular Institute, the technology allows a clinician to image a patient from every possible angle without having to move the patient or table. Given the proliferation of minimally invasi (Read more...)

Mobilett Elara Max X-ray Cleared in the United States

Siemens Healthineers won clearance from the FDA for its Mobilett Elara Max X-ray system. The mobile device can be wheeled from room to room while the cables are safely hidden inside and the antimicrobial coating prevents the transfer of pathogens. The firm touts the system’s IT security features that help to maintain patient privacy whil (Read more...)

Robocath R-One Robotic Angioplasty System Cleared in Europe

Robocath, based in Rouen, France, landed European regulatory approval to introduce its R-One robotic catheterization system. The R-One provides interventional cardiologists a way to precisely advance and manipulate catheter-based tools while remaining apart from patients and not exposed to dangerous X-rays. The company believes that the system can (Read more...)

Medtronic’s RF Ablation Platform FDA Cleared to Control Pain

Medtronic won FDA clearance for its Accurian RF system for ablation of nerve tissues. The system delivers radiofrequency signals to heat up targeted nerves, in the process soothing the pain associated with those nerves. Following ablation, the tissue is no longer capable of generating the pain signals, so if the targeting is done correctly the [&he (Read more...)

iVascular’s Navitian Coronary Microcatheters for Chronic Total Occlusions Cleared in EU

iVascular, a Spanish company that makes catheter-based devices, won the European CE Mark for its new Navitian coronary microcatheter. The device is indicated as a support for guidewires, helping to exchange guidewires, and for injection of radiopaque contrast agents, as well as saline solution. The company designed the device to help address chroni (Read more...)