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). 

TherOx Inc., a medical device company focused on the treatment of Acute Myocardial Infarction (AMI), announced that data will be presented on its Supersaturated Oxygen (SSO2) Therapy at the upcoming 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation, on Thursday, October 31. The presentation will include results from the company's multicenter Investigational Device Exemption (IDE) pilot study of a second-generation system that delivers SSO2 Therapy for reduction of infarct size after an AMI.

ContextVision released another ultrasound product for the mid-end ultrasound segment; a new version of the image enhancement software US PlusView was designed for the digital signal processor (DSP).


International Business Machine (IBM) Research unveiled two new Watson-related cognitive technologies that are expected to help physicians make more informed and accurate decisions faster and to cull new insights from electronic medical records (EMR).

Launching a clinical trial expected to serve as the foundation for global regulatory approvals, a physician in Auckland, New Zealand has performed the first patient implant of the Boston Scientific Corporation Innova Drug-Eluting Stent (DES) System.

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