SYS-CON MEDIA Authors: Pat Romanski, Michael Jannery, Javier Paniza, Kevin Jackson, Glenn Rossman

News Feed Item

The Myxo File Part I and II Helps to Decode the Mystery of the FDA 510(k) Regulatory Process

CHICAGO, December 18, 2012 /PRNewswire/ --

- With Photo

Understanding the regulatory issue surrounding the FDA 510(k) process may soon be a thing of the past thanks to a new book called The Myxo File: Part I and Part II  just release through Kindle Direct Publishing. "The patients will understand what happened during their open heart procedure to repair their heart valve between 2006-2008."  says author Nalini Marie Rajamannan M. D. Sacred Heart Cardiology, Chicago IL.

     (Logo: http://photos.prnewswire.com/prnh/20121218/584152 )

"With the Myxo File Part I and Part II, the biographical story and the documents providing the evidence from the FDA, US Patent office and the United States Securities and Exchange Commission websites will help to explain the events that happened during the clinical study to test a new invention in the hearts of her patients during open heart surgery.

"My book will help to educate the patient ask the important questions prior to open heart surgery as to whether the device that will be used to repair their valve is FDA registered, cleared, approved, investigational or none of the above."

Rajamannan was inspired to create the Myxo File when the documents she accumulated over a five year quest to get the information regarding the patients ended with a search of the US SEC website. The Filings indicate the chronology of disclosures of the medical device to investors. "With my electronic file, you still have to take action, and ask your physicians whether you are about to be included in a clinical study to test devices prior to FDA clearance, but at least the citizens of the United States will have a guidepost to help them ask the right questions.

Nalini M. Rajamannan is a cardiologist at Sacred Heart Cardiology, Sheboygan, WI, and Chicago, IL. She is the CEO of ConcieValve LLC, and recently published her textbook on Cardiac Valvular Medicine, Springer Publisher. She graduated from the University of Notre Dame, South Bend IN and Mayo Medical School and Mayo Graduate School, Rochester MN for all of her medical training. She is the chair of the recently published position statement from the NHLBI, NIH working group on Calcific Aortic Valve Disease. Dr. Rajamannan has published an International Clinical trial on the effects of statins in slowing the progression of aortic valve disease in the Journal of the American College of Cardiology with her colleagues from Spain and Portugal.

Image with caption: "The Myxo File Part I and II by Nalini M. Rajamannan, MD. (CNW Group/ConcieValve LLC)". Image available at: http://40rhel5streamview01.newswire.ca/media/2012/12/18/20121218-646251-21949-8365004f-855a-4e70-b25a-4e47c90b694f.jpg 

Note to Editors:

A picture accompanying this release is available through the PA Photowire. It can be downloaded from http://www.pa-mediapoint.press.net or viewed at http://www.mediapoint.press.net or http://www.prnewswire.co.uk

For further information:
Kindle Direct Publishing: The Myxo File: Part I and Part II.
Nalini Rajamannan
+1-312-266-7360

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
SYS-CON Events announced today that that Innodisk, the service-driven provider of industrial embedded flash and DRAM storage products and technologies, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Innodisk is a service-driven provider of industrial embedded flash and DRAM storage products and technologies. With satisfied customers across the embedded, aerospace and defense, cloud storage markets an...
The 3rd International Internet of @ThingsExpo, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that its Call for Papers is now open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than 20 years ago.
Connected devices and the Internet of Things are getting significant momentum in 2014. In his session at Internet of @ThingsExpo, Jim Hunter, Chief Scientist & Technology Evangelist at Greenwave Systems, examined three key elements that together will drive mass adoption of the IoT before the end of 2015. The first element is the recent advent of robust open source protocols (like AllJoyn and WebRTC) that facilitate M2M communication. The second is broad availability of flexible, cost-effective ...
At 15th Cloud Expo, Shrikant Pattathil, Executive Vice President at Harbinger Systems, demos a video delivery platform that helps you do interactive videos. He discusses how Harbinger is accomplishing it in the cloud world, the problems they faced and the choices they made to get around these problems.
"Our premise is Docker is not enough. That's not a bad thing - we actually love Docker. At ActiveState all our products are based on open source technology and Docker is an up-and-coming piece of open source technology," explained Bart Copeland, President & CEO of ActiveState Software, in this SYS-CON.tv interview at DevOps Summit at Cloud Expo®, held Nov 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Fundamentally, SDN is still mostly about network plumbing. While plumbing may be useful to tinker with, what you can do with your plumbing is far more intriguing. A rigid interpretation of SDN confines it to Layers 2 and 3, and that's reasonable. But SDN opens opportunities for novel constructions in Layers 4 to 7 that solve real operational problems in data centers. "Data center," in fact, might become anachronistic - data is everywhere, constantly on the move, seemingly always overflowing. Net...

ARMONK, N.Y., Nov. 20, 2014 /PRNewswire/ --  IBM (NYSE: IBM) today announced that it is bringing a greater level of control, security and flexibility to cloud-based application development and delivery with a single-tenant version of Bluemix, IBM's

The move in recent years to cloud computing services and architectures has added significant pace to the application development and deployment environment. When enterprise IT can spin up large computing instances in just minutes, developers can also design and deploy in small time frames that were unimaginable a few years ago. The consequent move toward lean, agile, and fast development leads to the need for the development and operations sides to work very closely together. Thus, DevOps become...
Building low-cost wearable devices can enhance the quality of our lives. In his session at Internet of @ThingsExpo, Sai Yamanoor, Embedded Software Engineer at Altschool, provided an example of putting together a small keychain within a $50 budget that educates the user about the air quality in their surroundings. He also provided examples such as building a wearable device that provides transit or recreational information. He then reviewed the resources available to build wearable devices at ...
Mobile commerce traffic is surpassing desktop, yet less than 20% of sales in the U.S. are mobile commerce sales. In his session at 15th Cloud Expo, Dan Franklin, Segment Manager, Commerce, at Verizon Digital Media Services, defined mobile devices and discussed how next generation means simplification. It means taking your digital content and turning it into instantly gratifying experiences.
The Internet of Things promises to transform businesses (and lives), but navigating the business and technical path to success can be difficult to understand. In his session at @ThingsExpo, Sean Lorenz, Technical Product Manager for Xively at LogMeIn, demonstrated how to approach creating broadly successful connected customer solutions using real world business transformation studies including New England BioLabs and more.
NuoDB just introduced the Swifts 2.1 Release. In this demo at 15th Cloud Expo, Seth Proctor, CTO of NuoDB, Inc., discussed why scaling databases in the cloud is challenging, why building your application on top of the infrastructure that is designed with this in mind makes a difference, and what you can do with NuoDB that simplifies your programming model, your operations model.
Since 2008 and for the first time in history, more than half of humans live in urban areas, urging cities to become “smart.” Today, cities can leverage the wide availability of smartphones combined with new technologies such as Beacons or NFC to connect their urban furniture and environment to create citizen-first services that improve transportation, way-finding and information delivery. In her session at @ThingsExpo, Laetitia Gazel-Anthoine, CEO of Connecthings, will focus on successful use c...
Enthusiasm for the Internet of Things has reached an all-time high. In 2013 alone, venture capitalists spent more than $1 billion dollars investing in the IoT space. With "smart" appliances and devices, IoT covers wearable smart devices, cloud services to hardware companies. Nest, a Google company, detects temperatures inside homes and automatically adjusts it by tracking its user's habit. These technologies are quickly developing and with it come challenges such as bridging infrastructure gaps,...
“The year of the cloud – we have no idea when it's really happening but we think it's happening now. For those technology providers like Zentera that are helping enterprises move to the cloud - it's been fun to watch," noted Mike Loftus, VP Product Management and Marketing at Zentera Systems, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.