Cardiology FDA

Edwards Lifesciences slides after FDA slaps Class I on Sapien 3 Ultra recall

Released on August 23, 2019

Edwards Lifesciences (NYSE:EW) shares slid today after the FDA slapped Class I status on last month’s recall of its Sapien 3 Ultra…

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Cardiology FDA

FDA grants breakthrough nod to Miracor Medical’s PiCSO device

Released on August 22, 2019

Miracor Medical said today that it received breakthrough designation from the FDA for its PiCSO device for treating a type of…

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AI Cardiology

AI Finds Hidden Atrial Fibrillation in Subtle Beats of the Heart

Released on August 22, 2019

Atrial fibrillation, the fleeting arrhythmia of the heart, is hard to catch. Elusive and intermittent, it’s often overlooked during a seconds-long electrocardiogram …

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Cardiology

Experts Caution Against Catch-all Assumptions About LVADs and Mitral Regurgitation

Released on August 22, 2019

Left ventricular assist devices (LVADs) have been shown to help leaky mitral valves that create significant regurgitation, but a new study questions the presumption that all’s well with the mitral valve after…

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Cardiology

Adagio Gives Afib Cold Treatment in Hot Market

Released on August 20, 2019

Adagio Medical is vying to get its treatment for persistent atrial fibrillation treatment on the market…

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Cardiology

Philips announces European launch of HeartStart Intrepid defib

Released on August 19, 2019

Royal Philips (NYSE:PHG) today announced that it launched its HeartStart Intrepid monitor/defibrillator with IntelliSpace Connect in Europe…

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Cardiology FDA Approved

BREAKING: FDA approves TAVR valves for low-risk patients

Released on August 16, 2019

The FDA today expanded the approval for replacement heart valves made by Medtronic (NYSE:MDT) and Edwards Lifesciences (NYSE:EW) to include patients at low risk from open heart surgery…

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Cardiology Healthcare

Abbott’s MitraClip may win expanded Medicare coverage

Released on August 16, 2019

The Center for Medicare and Medicaid Services (CMS) announced yesterday that it will study whether to extend coverage of the MitraClip transcatheter mitral valve repair (TMVR) device in cases of secondary mitral regurgitation,,,

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Cardiology

Glenfield Hospital surgeons use 3D heart map in operations

Released on August 15, 2019

Cardiologists are using innovative technology to allow them to operate while viewing a real-time 3D heart map…

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Cardiology FDA

V-Wave’s Interatrial Shunt Receives FDA Breakthrough Device Designation for Heart Failure

Released on August 15, 2019

V-Wave Ltd., today announced that the U.S. Food and Drug Administration (FDA) has just granted the company a Breakthrough Device Designation for its interatrial shunt for Heart Failure (HF)…

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Cardiology

Abiomed wins extended Medicare coverage for Impella

Released on August 15, 2019

Abiomed has won a one-year reprieve from a proposed 27% Medicare reimbursement cut to hospitals for the use of its Impella ventricular support device…

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Cardiology Funding

Startup Respirix raises $1.3m

Released on August 14, 2019

Heart failure detection startup Respirix has reported raising $1.3 million, according to a securities…

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