Endologix Inc. received notice that the U.S. Food and Drug Administration (FDA) has classified a voluntary recall action that Endologix took in July of this year as a Class I recall. The July recall involved Endologix’s issuance of a Safety Notice to healthcare professionals (HCPs) using the AFX Endovascular AAA System.

An example of a comprehensive CVIS is the ScImage Picom 365 system, which includes several sub-speciality reporting modules to eliminate the need for several different, disparate reporting systems in the cardiology department. Also called cardiac PACS cardiovascular information and imaging systems.

“I don’t trust anything that’s being portrayed in the marketing brochures and will believe it only when the solution is implemented and adopted,”  said a cardiologist at a recent steering committee meeting for a luminary healthcare organization I attended. While both blunt and bold, it resonated with me as it accurately summarized the cardiovascular information and imaging systems (CVIS) market, as well as my own experience with various CVIS deployments.

Veryan Medical Ltd has received Premarket Approval (PMA) for the BioMimics 3D Vascular Stent System from the U.S. Food & Drug Administration (FDA). The device is approved for the treatment of symptomatic de novo or restenotic lesions in the native superficial femoral artery and/or proximal popliteal artery.

Teleflex Inc. announced the acquisition of Essential Medical Inc. Based in Exton, Pa., Essential Medical is a privately-held medical device company that has developed and commercialized the CE Marked Manta Vascular Closure Device specifically designed for closure of large bore arteriotomies following procedures utilizing devices or sheaths ranging in size from 10F to 18F (with maximum outer diameters up to 25F).

The Ohio State University Wexner Medical Center is first in the country to test a new medical device designed to help patients with advanced heart failure. Cardiologists here performed the first two implants and the patients went home the next day.

October 4, 2018 — The late-breaking FAST-FFR Trial demonstrated that the sensitivity and specificity of the CathWorks FFRangio angiography imaging derived fractional flow reserve (FFR-angio) technology matched the performance of wire-based FFR measurements. The data were presented at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) annual meeting.

Fujifilm SonoSite Inc. announced its entry into the medical informatics space with the launch of a robust point-of-care workflow solution, SonoSite Synchronicity. The software is designed specifically for point-of-care ultrasound to streamline and standardize clinical workflow while delivering administrative efficiencies with flexible credentialing tools.

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