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August 7, 2014 — The Berlin Heart Group announced they have completed enrollment in their post-approval study, the only condition of the humanitarian device exemption (HDE) approval that Berlin Heart received for the Excor pediatric ventricular assist device (VAD) on Dec. 16, 2011.

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August 7, 2014 — A newly released study by IMV Medical Information Division shows cardiology departments in U.S. hospitals are moving beyond separate cardiovascular image management systems (cardiac picture archiving and communications systems [PACS]) and information systems (CVIS), with an eye to the improved efficiency provided by integration with other capabilities such as radiology PACS, other departmental IT systems and the hospital’s EMR (electronic medical records) system.

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Transluminal Technologies LLC, a Syracuse, NY-based medical device company, received CE mark approval for the velox CD Vascular Closure Device.

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Tryton Medical Inc. announced that the first patient has been enrolled in the EXTENDED Access Registry (Tryton IDE XA registry), a single arm clinical study of its Tryton Side Branch Stent.

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August 6, 2014 — St. Jude Medical announced the Center for Medicare and Medicaid Services (CMS) has approved a new technology add-on payment (NTAP) for the CardioMEMS heart failure (HF) monitoring system.

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August 6, 2014 — Cerner Corp. and Siemens AG announced the signing of a definitive agreement for Cerner to acquire the assets of Siemens' health information technology business unit, Siemens Health Services, for $1.3 billion in cash.

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Medtronic, Acist Agreement FFR-IVUS Technologies
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Acist Medical Systems entered into a strategic agreement with Medtronic to co-promote the world’s first Rapid Exchange FFR (RXi) and high definition IVUS (HDi) technologies in the United States.

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Decision Resources Group finds that the United States clot management device market will expand through 2022, particularly in the later years.

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August 5, 2014 — A survey, published online in the European Journal of Cardio-Thoracic Surgery, of 13,860 patients who had undergone interventions for aortic valve disease in Germany has revealed that more than 80 percent were in the same or a better state of health one year after the intervention, and was satisfied with the procedural outcome.

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August 5, 2014 — GE Healthcare announced the first integrated, simultaneous, time-of-flight (TOF) capable, whole-body Signa PET/MR (positron emission tomography/magnetic resonance) is 510(k) pending at the U.S. Food and Drug Administration (FDA).

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There are rising concerns over cyber security and how to enforce HIPAA and allow the securing medical information.
Feature | Cybersecurity | Lysa Myers

Did you know that medical data on 20,000 people could be exposed to abuse today? According to the U.S. Department of Health and Human Services (HSS), that is the number of people whose protected health information was breached per day on average in 2013. While healthcare practitioners may not realize the value of the data in their care, criminals certainly do. Clinicians and nurses may feel wary of security measures that might slow them down, but there are ways to improve security that will not cost precious moments in an emergency situation. Being lax with security can have a long-lasting impact on all of your patients, not just those with emergencies.

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Technology

OSTAR Healthcare Technology, a Washington State-based Medical Device and Healthcare IT company, announced the North American launch of its P Series Cloud Based Telehealth Blood Pressure Monitoring System, powered by 3SI (3 simultaneous interpretations) Interpretive Blood Pressure Monitoring Algorithm.

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The launch of several drugs with “extraordinary blockbuster potential” will cause the acute coronary syndrome (ACS) treatment market to more than triple in value, from $12.3 billion in 2013 to $43.4 billion by 2023, according to research and consulting firm GlobalData.

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radiation dose management in medical imaging
Feature | Neil Singh, Ascendian Healthcare Consulting?

Patient radiation dose safety has become the latest buzzword. With the emerging regulations and mandates, technologies and best practices, the radiation safety information pool has become convoluted with disparate and conflicting information. With numerous opinions and interpretations on radiation safety trends, best practices, regulation updates and studies, healthcare providers as well as the general public are experiencing difficulties filtering the true message in managing patient radiation dose away from the industry noise. Healthcare providers are constantly reviewing and assessing regulations, best imaging processes and the emerging technologies (automated dose management systems and dose management CT devices) promising to decrease or eliminate the chance of another sentinel event.

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CT scan showing Egyptian mummy with calcified aortic bifurcation.
Feature | CT Angiography (CTA)

New research published in June issue of Global Heart (the journal of the World Heart Federation) show that there are no significant differences in the incidence or severity of atherosclerotic disease (narrowing of the arteries with fatty deposits) between ancient and modern people, showing that atherosclerosis is not just a disease of modern times. The journal included three articles [1,2,3] on the finding of the HORUS Study, which used CT scans from ancient mummies to compare arterial calcification caused by HORUS atherosclerosis.

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