August 22, 2017 — LivaNova PLC announced its Perceval sutureless aortic heart valve received approval from the Centers for Medicare and Medicaid Services (CMS) for a New Technology Add-on Payment (NTAP). The Perceval valve met the CMS criteria for NTAP, including the demonstration of substantial clinical improvement over existing technologies. Beginning on Oct.

HeartSciences announced the European launch of the MyoVista high sensitivity electrocardiograph (hsECG) Testing Device, developed in response to the global unmet need for effective, low-cost, front-line screening of cardiac disease in both symptomatic and asymptomatic patients. MyoVista measures the heart's energy during each heartbeat using a type of advanced signal processing known as Continuous Wavelet Transform (CWT).

The U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) recently launched a revised web tool that puts important information on cybersecurity breaches into the hands of individuals. The tool is designed to empower them to better identify recent breaches of health information and to learn how all breaches of health information are investigated and successfully resolved.

Biotronik announced U.S. Food and Drug Administration (FDA) approval and commercial availability of Edora HF-T QP, an MR conditional quadripolar (QP) cardiac resynchronization therapy pacemaker (CRT-P) with MRI (magnetic resonance imaging) AutoDetect technology.

The Centers for Medicare and Medicaid Services (CMS) in August announced a proposed rule to cancel the Episode Payment Models (EPMs) used in cardiac bundled payments for patients with acute chest pain. The proposed rule also may eliminate the cardiac rehabilitation (CR) incentive payment model. Acute cardiac care bundled payments for patients with myocardial infarction who undergo percutaneous coronary intervention (PCI) with or without stenting, or coronary bypass graft surgery (CABG), was supposed to go into effect July 1, 2017. CMS pushed this back to Jan.

Medtronic plc announced a global randomized clinical trial that will evaluate one-month dual antiplatelet therapy (DAPT) in patients implanted with the Resolute Onyx Drug-Eluting Stent (DES) during percutaneous coronary intervention (PCI). Designed to evaluate clinical DAPT outcomes between two DES for the first time ever, the RESOLUTE ONYX ONE-MONTH DAPT Study intends to help inform DAPT guidelines for newer-generation DES that currently favor bare-metal stents (BMS) for patients with stable ischemic heart disease who might require a shorter dual antiplatelet regimen.

August 18, 2017 — The American Society of Nuclear Cardiology (ASNC) has released a joint expert consensus document with the Society of Nuclear Medicine and Molecular Imaging (SNMMI) on the role of 18F-FDG positron emission tomography/computed tomography (PET/CT) in cardiac sarcoid detection and therapy monitoring.

Healthcare cybersecurity concerns have increased dramatically as EMRs and medical devices become more digitally connected.

August 17, 2017 — Cybersecurity has become a growing concern in healthcare as patient data, medical systems and implantable devices become more digitally connected. The lax cyber security measures in healthcare IT have also spurred a large number of hacking attacks and ransomware attacks on U.S. hospitals over the past few years. After a financial market report last August unveiled cybersecurity vulnerabilities on electrophysiology devices and monitoring systems that use wireless communications, there have been questions about how security of medical devices should be regulated. The U.S.

Houston Methodist Hospital and Siemens Healthineers have entered into a multi-year agreement to bring cutting-edge technology to Houston Methodist that is not currently available in the Texas Medical Center. This agreement will provide innovative, world-class medical technology to Houston Methodist Hospital and all of its community hospital facilities.

ScImage Inc. was recently awarded a new DIN-PACS IV (Digital Imaging Network/Picture Archiving and Communications System) contract by the U.S. government. The contract is potentially valued up to $400 million, and the terms include one five-year base period and one five-year option period.

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