FDA, CDRH, national evaluation system, medical device development

The U.S. Food and Drug Administration (FDA) announced it is building the foundations of a national evaluation system to generate better evidence more efficiently for medical device evaluation and regulatory decision-making.

Biotronik announced U.S. Food and Drug Administration (FDA) approval of Iperia ProMRI HF-T, a cardiac resynchronization defibrillator that provides heart failure patients with access to diagnostic magnetic resonance imaging (MRI) scans.

The global market for contrast media injectors is set to increase from $830 million in 2015 to almost $1.8 billion by 2022, according to research and consulting firm GlobalData.

May 3, 2016 — Good news for clinicians and their patients: the evaluation of left ventricular (LV) diastolic function using echocardiography just got a bit simpler. New streamlined algorithms have been developed since an earlier joint publication by the American Society of Echocardiography (ASE) and the European Association of Cardiovascular Imaging (EACVI).

May 2, 2016 — Hitachi Medical Systems America Inc. announced its All-Inclusive Service and Support Program for its Premium Performance Scenaria SE 64/128-slice computed tomography (CT) system. The All-Inclusive program provides Hitachi’s latest Premium 128-slice CT equipment with five years all-inclusive support.

Hitachi’s All-Inclusive program substantially reduces total five-year cost, eliminates unbudgeted surprises and includes all the support elements that most buyers need, including:

Echo on Marco Island: Case-Based Approach

Cardiology at Cancun: Topics in Clinical Cardiology

A Mayo Clinic sponsored event.

Arrhythmias and the Heart: A Cardiovascular Update

A Mayo Clinic sponored event.

Hawaii Heart: Echocardiography and Multimodality Imaging Case-Based Clinical Decision Making

The Heart Beat of Cardiology: Practical Application of Echocardiography

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