Three years ago this week, Abiomed's Impella heart pump received U.S. Food and Drug Administration (FDA) premarket approval (PMA) for acute myocardial infarction (AMI) cardiogenic shock. At the time of Impella’s FDA PMA approval, the cardiogenic shock survival rate to explant in the Impella Quality Assurance (IQ) Database was 51 percent in the United States1. Today, Impella heart pumps, combined with the adoption of best practices that include the use of Impella pre-percutaneous coronary intervention (PCI), have contributed to a significant increase in cardiogenic shock survival and native heart recovery. New data from the IQ Database on nearly 5,000 patients treated between April 2018 and March 2019 show an increase in survival from 51 percent to 67 percent2, a relative increase of 34 percent in survival.

The U.S. Food and Drug Administration (FDA) granted Omega Medical Imaging 510(k) clearance to offer their artificial intelligence (AI)-powered region of interest (ROI) radiation exposure reduction solution FluoroShield for interventional X-ray imaging on their flat panel detector CS-series product lines.

Increasing demand for innovative diagnostic techniques, neurological disorders and increasing disease awareness are expected to drive growth of virtual reality (VR) in the healthcare market over the next several years, according to new research from Reports and Data. The report projects the market will reach a value of $6.91 billion by 2026. Advancements in the field of information technology (IT), including laptop, computer, internet connectivity and mobile applications will also be a significant factor stimulating market demand.

April 3, 2019 – The ACC.19 late-breaking landmark Evolut Low Risk Trial compared the minimally invasive Evolut transcatheter aortic valve replacement (TAVR) system to the gold standard of open-heart surgery in characteristically younger, healthier aortic stenosis patients. The randomized trial, which met its primary non-inferiority endpoint of all-cause mortality or disabling stroke at two years compared to surgery (5.3 vs.

April 3, 2019 — The U.S. Food and Drug Administration (FDA) recently granted an additional indication to Bard Peripheral Vascular's Covera Vascular Covered Stent for the treatment of a stenosis or blockage which has developed anywhere in the access circuit of patients on hemodialysis using an arteriovenous (AV) fistula.

The device was previously approved for use in the treatment of stenoses at the venous anastomosis of ePTFE or other synthetic arterio-venous (AV) access grafts only. 

April 3, 2019 — The U.S. Food and Drug Administration (FDA) recently cleared Bard Peripheral Vascular's Venovo Venous Stent System intended to treat narrowed iliofemoral veins. 

April 3, 2019 — Essential Medical Inc. received U.S. Food and Drug Administration (FDA) clearance for its large bore Manta Vascular Closure Device. It is designed to close large puncture sites in the femoral artery from larger sized transcatheter devices, including the Impella heart pump, endovascular stent grafts and transcatheter valves. 

April 3, 2019 — Medtronic's Resolute Integrity Zotarolimus-eluting Coronary Stent System received an additional U.S. Food and Drug Administration (FDA) indication for treatment of de novo chronic total occlusion (CTO) lesions. The stent is also indicated for improving coronary luminal diameters in patients, including those with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions of length ≤ 35 mm in native coronary arteries with reference vessel diameters of 2.25 - 4.2 mm. 

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., announced Tuesday the agency is pursuing a new framework in which to review artificial intelligence (AI)-based medical software and devices to ensure ongoing effectiveness and patient safety. The agency released a 20-page discussion paper explaining the need for a new framework, the tenets of a total product lifecycle (TPLC) approach to certification, and examples of potential real-world AI software modifications that may or may not be permitted under the proposed framework. The FDA is asking for comments and feedback from all parties to inform future decisions.

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