minneapolis

Newly Minted FDA Commissioner Dr. Stephen Hahn Receives Minneapolis FDA Affidavit From Dr. Nalini Rajamannan Regarding FDA Design Control Study Using a Non-Exempt Medical Device

Minneapolis FDA confirms no plan to inform patients of non-exempt medical devices placed in 667 citizens
Press Release – updated: Jan 22, 2020 05:00 EST

SHEBOYGAN, Wis., January 22, 2020 (Newswire.com) – Most Sacred Heart of Jesus Cardiology and Valvular Institute Medical Director Dr. Nalini Rajamannan has sent the FDA Affidavit outlining Illinois and Minnesota testimonies to the newly Minted FDA Commissioner Dr. Hahn, as of December 2019.
Dr. Stephen Hahn is a radiation oncologist formally working at M.D. Anderson in Texas and an experienced clinical trial specialist. The Illinois and Minnesota Attorney General’s offices and the Chicago Mayor’s office are reviewing the Minneapolis FDA Affidavits regarding Patient’s rights under HHS Federal Codes for human subject research. The Food and Drug Administration (FDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is led by the Commissioner of Food and Drugs, appointed by President Trump with the advice and consent of the United States Senate.
The FDA Commissioner, Dr. Hahn has oversight to protect citizens in the United States 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 also received 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 Amazon.com. 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.
7) Dr. Rajamannan awaiting response by the FDA to inform the patients of the design control study under 21CFR810.30 as reviewed by the FDA Minneapolis office.
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 America773-573-6890oidwinds@gmail.com
Source: Most Sacred Heart of Jesus Cardiology

January 2020, Dr. Rajamannan Confirms Minneapolis FDA Investigation of Newly Released Non-Exempt Status to Senator Amy Klobuchar's Minneapolis Senate Office

Releasing FDA Congressional letter to Senator Charles Grassley (IA), confirming heart valve status on the eve of the Iowa Debates
Press Release – updated: Jan 14, 2020 05:00 EST

MINNEAPOLIS, January 14, 2020 (Newswire.com) – Dr. Nalini Rajamannan — a specialist for patients with valvular heart disease in Most Sacred Heart of Jesus Cardiology, Sheboygan, WI — confirms FDA statements to Senator Amy Klobuchar Minneapolis Senate Office on January 13, 2020. Senator Klobuchar has followed the investigation since 2014, during the Senate Judiciary Committee Investigation led by Senator Charles Grassley (IA). Dr. Rajamannan met with Program Division Director for Bioresearch Monitoring West, at the FDA Branch in Minneapolis MN to review medical outcomes of the use of the non-exempt heart device, (Please See Linked Affidavit signed by the FDA, the Doctor and patients.) The surgical protocol for these devices began in 2006, as reported by the Project on Government Oversight. 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” 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 Amazon.com. 
Dr. Rajamannan received and submitted to Senator Klobuchar the FDA Congressional to the Senate Finance Committee’s Chairman Grassley(IA) 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.) The Chicago FDA office released an FDA Freedom of Information in anticipation of the meeting in Minneapolis, MN. The Inspection report confirms the University decision to stop the study after three months. 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 America773-573-6890oidwinds@gmail.com
Source: Most Sacred Heart of Jesus Cardiology and Valvular Institute

Greenberg Traurig Continues Strategic Growth of Minneapolis Office with Addition of Margaret Weil

“I am thrilled to join Greenberg Traurig and its highly-regarded team of lawyers,” Weil said. “I look forward to working with my new colleagues with the goal of delivering the best service to our clients.”

MINNEAPOLIS (PRWEB) January 07, 2020
The Minneapolis office of global law firm Greenberg Traurig, LLP continues its strategic expansion with the addition of Margaret J. Weil as of counsel in the firm’s Tax Practice. She joins Greenberg Traurig from Fredrikson & Byron, P.A. where she was an officer.
“We are happy to welcome Margaret to Greenberg Traurig as we continue to expand our Minneapolis office to meet our clients’ ever-changing needs,” said Michael B. Fisco, managing shareholder of Greenberg Traurig’s Minneapolis office. “Margaret brings considerable experience advising clients in domestic and international transactions and will be an excellent addition to the practice and the firm.”
Weil focuses her practice on tax planning and advice for private equity transactions, mergers and acquisitions, financings, and other commercial transactions. She advises domestic and international corporations, partnerships, and high-net-worth individuals on a broad range of tax matters, including domestic and cross-border M&A, securities offerings, restructurings, tax compliance, and the federal, state, and international tax developments that affect their transactions and ongoing business operations.
“I am thrilled to join Greenberg Traurig and its highly-regarded team of lawyers,” Weil said. “I look forward to working with my new colleagues with the goal of delivering the best service to our clients.”
Weil earned her LL.M. in taxation from New York University School of Law, her J.D. from the University of California, Berkeley School of Law, and her B.A., cum laude, from New York University.
About Greenberg Traurig’s Tax Practice: To stay competitive in today’s global marketplace, international companies must seek out greater efficiency in their tax planning and compliance, including coordinating tax decisions from country to country. For U.S. operations, an environment of increased scrutiny – including passage of more restrictive legislation and a spike in audit activity at every level – is quickly becoming the norm, likewise spurring a need for greater self-evaluation and for more frequent representation in controversies and litigation with tax authorities. Greenberg Traurig’s multidisciplinary tax team works closely with clients to address these and other tax planning needs, as well as tax controversies and litigation issues.
About Greenberg Traurig’s Minneapolis Office: Established in 2019, Greenberg Traurig’s Minneapolis office provides clients with an innovative, business-minded perspective along with strong location connections to business, industry and government. The office’s core capabilities include commodities and structured finance, restructuring and bankruptcy, corporate trust and structured products litigation, finance and financial services litigation, environmental litigation, intellectual property, and agribusiness.
About Greenberg Traurig: Greenberg Traurig, LLP (GT) has approximately 2100 attorneys in 41 locations in the United States, Latin America, Europe, Asia, and the Middle East. GT has been recognized for its philanthropic giving, diversity, and innovation, and is consistently among the largest firms in the U.S. on the Law360 400 and among the Top 20 on the Am Law Global 100. Web: http://www.gtlaw.com Twitter: @GT_Law.

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Sun50 Hosts Minneapolis Launch Party: The Authentic Brand in Sun Protection Apparel

Sun Protective Clothing You Cannot Wait to Wear.

“The way you live your life is up to you, we just want you to live it to the fullest,” says Covarrubias.

MINNEAPOLIS and ST. PAUL, Minn. (PRWEB) November 14, 2019
Sun50, a lifestyle brand head-quartered in Minnesota, launched its opening collection of luxury UPF 50+ apparel and accessories which are made in Los Angeles, California. The inspiration for Sun50 is Christie Covarrubias, Co-Founder and CEO, who grew up in California during a time when sunscreen was virtually nonexistent. “My cousin, Renee, and I would spend our childhood summers on the beaches of Lake Tahoe in the water as much as possible, frequently sun burning our skin” says Covarrubias. In her early 30’s, Renee, was diagnosed with melanoma from a mole on her back and passed away 10 months later. “Had Renee known about skin cancer prevention and early detection, she would probably be alive today,” says Covarrubias. With Renee in mind, Sun50 was launched.
According to The Skin Cancer Foundation (SCF), the single most effective form of sun protection is UPF clothing. Grounded in their company mission to “reduce the incidence of skin cancer by supplying the world with the most fashion-forward, easy to wear, and socially impactful sun protective clothing available,” Sun50 fabrics are third party tested to ensure the highest levels of UV protection from the sun. In fact, each of their fabrics have earned The SCF Seal of Recommendation.
Sun50’s goal is to be a resource and a community of support for people affected by skin cancer. “You will not be just a customer, but a friend and member of our Sun50 family,” says Covarrubias. Sun50 is actively collaborating with organizations dedicated to the prevention of skin cancer including the American Academy of Dermatology, The Skin Cancer Foundation and The Claire Marie Foundation.
Kicking off their launch with a party in Minneapolis on November 15, the opening collection includes signature prints and beach inspired styles, hand-crafted from ultra-soft, sustainable lightweight fabrics. UPF 50+ sun hats and umbrellas, reef safe sunscreens, eco-friendly sandals and a limited-run, hand-woven tote imported from Madagascar round out the collection. The evening celebration will include signature cocktails, gourmet food, live music and the debut of their collection worn by fashion models.
“The way you live your life is up to you, we just want you to live it to the fullest,” says Covarrubias.
Visit Sun50.co to learn more and follow us on Instagram @sun50official
About Sun50Sun50 is more than an apparel company. It is a gathering place for people dedicated to reducing the incidence of skin cancer. Categorized as an American lifestyle brand, Sun50 features on-trend styles inspired by beach living which are made in Los Angeles, California. Each style is comfortably tailored, designed to provide optimum sun protective benefits and made with lightweight sustainable fabrics which have received The Skin Cancer Foundation Seal of Recommendation.
Brand Video: https://www.youtube.com/watch?v=o7jayl5CmQM

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