On Martin Luther King Day, Illinois and Minnesota Attorney Generals and Chicago City Mayor Lori Lightfoot Receive FDA Testimonies on Non-Exempt Medical Device as FDA Delays to Not Inform the Patients as Confirmed by Dr. Rajamannan

Minneapolis FDA confirms no plan to inform patients of non-exempt medical devices placed in 667 citizens
Press Release – updated: Jan 20, 2020 05:00 EST

SHEBOYGAN, Wis., January 20, 2020 ( – Most Sacred Heart of Jesus Cardiology and Valvular Institute Medical Director Dr. Nalini Rajamannan has sent an FDA Affidavit outlining Illinois and Minnesota testimonies to the Illinois and Minnesota Attorney General’s offices regarding Patient’s rights under HHS Federal Codes for human subject research. Chicago City Mayor Lori Lightfoot’s office and the Attorney General’s office have civic oversight to protect citizens in their city and states from receiving non-exempt FDA medical devices without informed consent.
The events follow recent reporting by Kaiser Health News that the FDA has lifted their exemption laws.​​ Dr. Nalini Rajamannan, a specialist for patients with valvular heart disease in Most Sacred Heart of Jesus Cardiology, confirms FDA statements after a decade of requesting answers from the FDA from her location in Downtown Sheboygan. Dr. Rajamannan revealed the confirmation FDA letter to Congressman Glenn Grothman that the Food and Drug Deputy Commissioner on policy for the FDA will not inform the patients regarding the status of a heart device implanted in 667 patients across the United States of America.
Former Board of Trustee for the University and now Governor of Illinois, Gov. Pritzker receives the FDA affidavit after years of delays by the FDA in reporting to the patients. The surgical placement for these devices began in 2006. In 2007, the device manufacturer confirmed the “exempt status” in a two-line email to the hospital. The saga related to the heart device is outlined by Dr. Elisabeth Rosenthal’s new book “An American Sickness”, which highlights the issues related to exempt medical devices in the chapter, “How to get into a Patient’s Heart? Follow the Money.” The chapter outlines the events summarized by eye-witness Dr. Nalini M. Rajamannan in the series “The Myxo Files a XXIV: A Tale of Three Rings” as published by Kindle Publishing on Dr. Rajamannan reviewed the FDA letter to the Senate Finance Committee’s Chairman Grassley after several years of investigations, classifying the device as not exempt from reporting the device to the FDA, and that the device manufacturer needs to submit a new approval application. (See Linked PDF of the FDA Congressional Letter.)
Summation points from the recent press conference at the Institute after a decade of FDA investigations:
1)    FDA report to Senate Finance Committee confirms the Myxo ETlogix Device is not exempt and needed an approval from the FDA.
2)    FDA letter to Senator Lugar confirms 667+ patients received the non-exempt device which needed an approval.
3)    FDA report to the House Committee on Government Oversight confirms that the FDA does not plan to inform the patients.
4)    Congressman Grothman is still waiting for a response as to why the FDA is not planning to inform the patients.
5)    HHS Inspector General Daniel Levinson is not planning to inform the patients of the non-exempt status of the heart device after requests for information by Senator Ron Johnson.
6)    Dr. Rajamannan Presented documents and affidavit to Senator Amy Klobuchar’s staff in Minneapolis. Senator Klobuchar has met with Dr. Rajamannan since 2014 in Washington DC, after the Senate Judiciary Committee began their investigation.
The information will help the 667+ patients to finally may get answers about whether medical devices placed in their bodies are tested and safe, as the Food and Drug Administration begins to allow access to volumes of previously shielded data from consumers as written to then-Senator Richard Lugar (IN) and Congressman Glenn Grothman (WI). The Senate Finance committee is involved in these investigations on behalf of Medicare and Medicaid because government dollars fund the use of medical devices in patients’ health. More importantly, the new changes to the FDA reporting laws as outlined by Kaiser Health News will help patients know more about medical devices implanted into their bodies.
Dr. Nalini Rajamannan is a heart valve expert in the field of cardiovascular medicine. She earned her undergraduate science pre-professional degree from the University of Notre Dame, her Medical Doctorate from Mayo Medical School and her post-graduate training in Internal Medicine and Cardiology at the Mayo Clinic and Research Fellowship on the NIH training Grant. She also worked at the Mayo Clinic as a staff consultant in Internal Medicine and an Associate Professor of Medicine at Northwestern University and the Lakeside and Westside VA. Currently, she practices consultative valvular medicine and Osteocardiology at Most Sacred Heart of Jesus Cardiology and Valvular Institute, WI.
​Press ContactOscar Delgado​​Press Officer for Most Sacred Heart of Jesus Cardiology and Valvular InstituteFormer NBC Bureau Chief Latin
Source: Most Sacred Heart of Jesus Cardiology and Valvular Institute

Yamaha Generation III “Chicago” and “New York” Artist Model Trumpets Continue Tradition of Innovation and Excellence

“These enhancements address the ever-changing needs of trumpet players…players are exploring new soundscapes and need an instrument that can grow and change as they need it to,” says Brian Petterson, senior manager, Winds & Strings, Yamaha.

ANAHEIM (PRWEB) January 16, 2020
Yamaha today showcased the Generation III “Chicago” and “New York” Artist Model Trumpets, representing the latest and most advanced in the respected and well-received line of Xeno Artist Model trumpets.
Not only are these models intended to meet the critical demands of today’s top trumpet players but they also serve as aspirational models for those seeking to reach the apex of their performance potential.
Since the launch of the first generation of Xeno Artist Model trumpets in 2005, Yamaha has never stopped optimizing the design of the instrument to enhance the playing experience of the performer. This continual quest for innovation embodies the Japanese philosophy of Kaizen, which literally means “to improve,” and for Yamaha instrument design, it has come to represent the pursuit of perfection.
The new Generation III trumpets exemplify this philosophy with a redesigned two-piece construction valve casting, along with unified parts such as the water-key set-up and tuning slide radius. These design alterations create an improved upper register and sound throughout the range, and more stable intonation which directly speak to pain points felt by players at all levels, especially those performing in the most critical situations.
With two Bb and three C models to choose from — YTR-9335CHS III, YTR-9335NYS III, YTR-9445CHS III, YTR-9445NYS-YS III, YTR-9445NYS-YM III — a large variety of players are satisfied, from those looking for a more modern style to those who prefer a more traditional feel and resistance.
The Generation III Artist Model trumpets can deliver even the most complex musical passages with a responsive playing feel, nuanced sound characteristics and accurate, even intonation, offering players the chance to create an incredibly meaningful artistic connection with the audience.
“These enhancements address the ever-changing needs of trumpet players,” says Brian Petterson, senior manager, Winds & Strings, Yamaha. “As new repertoire is written and new generations of music directors ascend the helms of major orchestras, players are exploring new soundscapes and need an instrument that can grow and change as they need it to.”
Pricing and AvailabilityThe Yamaha Generation III Chicago and NY Artist Model Trumpets — YTR-9335CHS III, YTR-9445CHS III, YTR-9335NYS III, YTR-9445NYS-YS III and YTR-9445NYS-YM III (MSRP of $6,315.00) — are now shipping.
For more information, please visit the Yamaha Booth at the 2020 NAMM Show in the Anaheim Marriott Hotel, Marquis Ballroom, January 16-19, 2020, or
About YamahaYamaha Corporation of America (YCA) is the largest subsidiary of Yamaha Corporation, Japan and offers a full line of award-winning musical instruments, sound reinforcement, commercial installation and home entertainment products to the U.S. market. Products include: Yamaha acoustic, digital and hybrid pianos, portable keyboards, guitars, acoustic and electronic drums, band and orchestral instruments, marching percussion products, synthesizers, professional digital and analog audio equipment, Steinberg recording products and NEXO commercial audio products, as well as AV receivers, amplifiers, MusicCast wireless multiroom audio systems, Blu-ray/CD players, earphones, headphones, home-theater-in-a-box systems, sound bars and its exclusive line of Digital Sound Projectors. YCA markets innovative, finely crafted technology and entertainment products and musical instruments targeted to the hobbyist, education, worship, music, professional audio installation and consumer markets.

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