Pie Medical Imaging B.V. (PMI) announced that they have signed an agreement with the Cardiovascular Research Foundation (CRF) to begin a close collaboration. Under this agreement, the CRF Clinical Trials Center will use PMI’s solutions in their Angiographic Core Laboratory for clinical research and multicenter trials. CRF will also support further development of PMI’s new products for analysis and visualization of medical images.

Medtronic Inc. announced the U.S. launch of the Export Advance aspiration catheter, a U.S. Food and Drug Administration (FDA)-cleared catheter that features a pre-loaded stylet that increases deliverability and kink resistance while traversing the vasculature to reach the aspiration site.

Bard Peripheral Vascular has sent an urgent Class I medical device recall notification letter informing customers of the problems of the LifeStent Solo vascular stent and the actions customers should take. The LifeStent Solo vascular stent is an implantable self-expanding stent and delivery system used to improve the superficial femoral artery (SFA) luminal diameter in the treatment of atherosclerotic lesions.

Amplatzer, St. Jude Medical, ASD closure

The U.S. Food and Drug Administration (FDA) issued a warning this week about safety issues encountered with the St. Jude Amplatzer Atrial Septal Occluder (ASO), a transcatheter device used to seal congenital holes in the atrial septum. The FDA reported in a rare safety communication that the device may cause life-threatening tissue erosion inside the heart.

M*Modal, a provider of clinical documentation services and Speech Understanding solutions, announced a medical dictation application for iPhone mobile digital devices, expanding the company’s mobility solutions.  The M*Modal Fluency Flex Mobile application lets doctors quickly and accurately record clinical notes during patient encounters for easy integration with electronic health record systems (EHRs), increasing physician productivity and documentation quality.

Deployable throughout the hospital enterprise, the new Dome S3c LED is an all-in-one 3 MP diagnostic display, featuring LED backlight technology for pristine color and grayscale imaging.

Covidien released positive final results from its Durability II study and promising preliminary data from its Definitive AR trial at the Vascular Interventional Advances (VIVA) 2013 conference in Las Vegas. These studies demonstrated the safety and effectiveness of technologies used in the treatment of peripheral arterial disease (PAD). 

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