(PRWEB) January 07, 2013
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 whether their heart device is FDA approved, cleared, investigational or not," says author Nalini Marie Rajamannan M. D. Sacred Heart Cardiology, Chicago IL.
"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."
Rajamannan was inspired to create the Myxo File when the documents she accumulated over a five year quest to get the information regarding her 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.