SYS-CON MEDIA Authors: Ian Khan, Liz McMillan, AppDynamics Blog, Harry Trott, Blue Box Blog

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 Isomorphic Software, the global leader in high-end, web-based business applications, will exhibit at SYS-CON's DevOps Summit 2015 New York, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Isomorphic Software is the global leader in high-end, web-based business applications. We develop, market, and support the SmartClient & Smart GWT HTML5/Ajax platform, combining the productivity and performance of traditional desktop software ...
DevOps Summit, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long developmen...
While Docker continues to be the darling of startups, enterprises and IT innovators around the world, networking continues to be a real mess. Indeed, managing the interaction between Docker containers and networks has always been fraught with complications. Without automation in networking, the vision of running Docker at scale and letting IT run the same apps unchanged on the laptop and in the data center or for any cloud cannot be realized.
DevOps Summit 2015 New York, 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 it is now accepting Keynote Proposals. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long development cycles that produce software that is obsolete...
Application metrics, logs, and business KPIs are a goldmine. It’s easy to get started with the ELK stack (Elasticsearch, Logstash and Kibana) – you can see lots of people coming up with impressive dashboards, in less than a day, with no previous experience. Going from proof-of-concept to production tends to be a bit more difficult, unfortunately, and it tends to gobble up our attention, time, and money. In his session at DevOps Summit, Otis Gospodnetić, co-author of Lucene in Action and founder...
“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.
“We are a managed services company. We have taken the key aspects of the cloud and the purposed data center and merged the two together and launched the Purposed Cloud about 18–24 months ago," explained Chetan Patwardhan, CEO of Stratogent, in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
SYS-CON Events announced today that CenturyLink, Inc., a leader in the network services market, has been named “Platinum Sponsor” of 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. CenturyLink is the third largest telecommunications company in the United States and is recognized as a leader in the network services market by technology industry analyst firms. The company is a global leader in cloud infrastructure and ...
Database apps on mobile devices shouldn't stop working when there's limited or no network connectivity. In his session at 16th Cloud Expo, Bradley Holt, a Developer Advocate for IBM Cloudant, will discuss how to bring data stored in a cloud database to the edge of the network (and back again), whenever an Internet connection is available. He will demonstrate techniques for replicating cloud databases with mobile devices in order to build offline-enabled mobile apps that can provide a better,...
In his session at 16th Cloud Expo, Simone Brunozzi, VP and Chief Technologist of Cloud Services at VMware, will review the changes that the cloud computing industry has gone through over the last five years and share insights into what the next five will bring. He will chronicle the challenges enterprise companies are facing as they move to the public cloud. He will delve into the “Hybrid Cloud” space and explain why every CIO should consider ‘hybrid cloud’ as part of their future strategy to a...
"Blue Box has been around for 10-11 years, and last year we launched Blue Box Cloud. We like the term 'Private Cloud as a Service' because we think that embodies what we are launching as a product - it's a managed hosted private cloud," explained Giles Frith, Vice President of Customer Operations at Blue Box, in this SYS-CON.tv interview at DevOps Summit, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Docker is becoming very popular--we are seeing every major private and public cloud vendor racing to adopt it. It promises portability and interoperability, and is quickly becoming the currency of the Cloud. In his session at DevOps Summit, Bart Copeland, CEO of ActiveState, discussed why Docker is so important to the future of the cloud, but will also take a step back and show that Docker is actually only one piece of the puzzle. Copeland will outline the bigger picture of where Docker fits a...
Puppet Labs on Wednesday released the DevOps Salary Report, based on salary data gathered from Puppet Labs' industry-recognized State of DevOps Report. The data confirms that market demand for DevOps skills is growing, and that DevOps engineers are among the highest paid IT practitioners today. That's because IT organizations today are grappling with how to be more agile and responsive to the business, while maintaining the stability of their infrastructure. DevOps practices, such as continuous ...
"SOASTA built the concept of cloud testing in 2008. It's grown from rather meager beginnings to where now we are provisioning hundreds of thousands of servers on a daily basis on behalf of customers around the world to test their applications," explained Tom Lounibos, CEO of SOASTA, in this SYS-CON.tv interview at DevOps Summit, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
“This win means a great deal to us because it is decided by the readers – the people who understand how use of our technology enables new insights that drive the business,” said Matt Davies, senior director, EMEA marketing, Splunk. “Splunk Enterprise enables organizations to improve service levels, reduce operations costs, mitigate security risks, enhance DevOps collaboration, create new product and service offerings and obtain deeper insight into customer behavior. Being named Best Business App...