February 14, 2018 — Abiomed Inc. announced it received an expanded U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for the Impella 2.5 and Impella CP heart pumps for use during elective and urgent high-risk percutaneous coronary intervention (PCI) procedures.
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February 14, 2018 — The U.S. Food and Drug Administration (FDA) announced marketing clearance for Viz.AI’s Contact application, the first artificial intelligence (AI)-based clinical decision support (CDS) solution cleared for sale in the U.S.
Abbott announced the first patient has been enrolled in a clinical trial evaluating 28 days of dual antiplatelet therapy (DAPT) in patients at high risk of bleeding after implantation with a Xience everolimus-eluting coronary stent. The first patient was enrolled into the study by Prof. Emanuele Barbato, M.D., Ph.D., a cardiologist at OLV-Hospital Aalst in Belgium.
Clinical research has revealed men and women often have different presentations for cardiovascular disease (CVD). This includes sex differences in terms of symptom presentation, in diagnostic imaging and in lab values. This may result in poor outcomes for women, whose symtoms do not match the classic presentations in males suffering from coronary ischemia. This can lead to female cardiac issues going undiagosed or misdiagnosed, accentuating a need for new approaches in diagnosing and treating women.
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February 12, 2018 — Philips is recalling the HeartStart MRx Defibrillator due to a defect in the device's Gas Discharge Tube (GDT) that may prevent the device from working automated external defibrillator (AED) mode, or produce noisy ECGs in manual mode. The U.S. Food and Drug Administration (FDA) last week announced it identified this as a Class I recall, the most serious type of recall. The FDA said use of these devices may cause serious injuries or death.
February 12, 2018 — Physicians now have access to more neuro and cardiac magnetic resonance imaging (MRI) capabilities with the Vantage Galan 3.0T XGO Edition from Canon Medical Systems USA, Inc. Outfitted with the all-new Saturn X Gradient, the system can provide up to 30 percent improved signal-to-noise ratio (SNR) for brain diffusion weighted imaging (DWI), resulting in even higher resolution neuro images than previously offered.
