Hooman Noorchashm – Medium

Hooman Noorchashm

Hooman Noorchashm

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Mar 28

The Dangerous 510(k) Strawman: FDA’s Circular Logic and the Constitutional Vulnerability in Medical…

How the Power Morcellator Citizen Petitions Reveal a Broken System at FDA That Camouflages Risk, Harms Patients, and Exposes Deep…

The Dangerous 510(k) Strawman: FDA’s Circular Logic and the Constitutional Vulnerability in Medical…

Hooman Noorchashm

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Mar 27

510(k): The FDA Market Clearance Process For MedTech That Threatens America’s Health Security

How the Camouflaged “Reasonable Assurance” of Safety and Effectiveness in MedTech, Triggers Cascading Harms to Patients and Taxpayers

510(k): The FDA Market Clearance Process For MedTech That Threatens America’s Health Security

Hooman Noorchashm

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Mar 22

The FDA’s 510(k) Clearance of enVast: A Dangerous Shortcut in a Life-or-Death Field

Vesalio markets enVast for life-threatening heart attacks in the U.S. without proving it is safe or effective

The FDA’s 510(k) Clearance of enVast: A Dangerous Shortcut in a Life-or-Death Field

Hooman Noorchashm

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Mar 14

Prioritizing Profits Over Patients: Debunking Scott Whitaker’s Push for Faster Medicare Coverage of…

A direct response to his February 24, 2026, Washington Times op-ed urging automatic reimbursement for FDA-authorized — but non-standard and…

Prioritizing Profits Over Patients: Debunking Scott Whitaker’s Push for Faster Medicare Coverage of…

Hooman Noorchashm

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Mar 8

Too Soon Gone: Yvonne Zucco’s Battle with Metastatic Breast Cancer After an Experimental Robotic…

How an Experimental Robotic Procedure On a Brave Patient With Breast Cancer Is Protecting Other Patients by Raising Serious Questions About…

Hooman Noorchashm

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Feb 28

Fraud by Design: Intuitive Surgical’s Deliberate Exploitation of the FDA’s Regulatory Loophole to…

A company sponsors a “significant-risk” IDE trial because the procedure is dangerous enough to require strict oversight — then turns around…

Fraud by Design: Intuitive Surgical’s Deliberate Exploitation of the FDA’s Regulatory Loophole to…

Hooman Noorchashm

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Feb 27

If You Had Robotic Breast Surgery at the Mayo Clinic or Another Hospital Outside of a Clinical…

If You or Your Loved One’s Cancer Has Come Back After Robotic Surgery, This Could Be Why — The Truth About What Wasn’t Disclosed to You

If You Had Robotic Breast Surgery at the Mayo Clinic or Another Hospital Outside of a Clinical…

Hooman Noorchashm

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Feb 27

Intuitive Surgical and Mayo Clinic’s Brazen FDA End-Run: Clearance to Sell Robotic Mastectomy While…

A 510(k) green light for the exact same indication still under active IDE — while long-term cancer safety data won’t be ready until 2031…

Intuitive Surgical and Mayo Clinic’s Brazen FDA End-Run: Clearance to Sell Robotic Mastectomy While…

Hooman Noorchashm

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Feb 22

URGENT PATIENT SAFETY WARNING TO MAYO CLINIC’S DR.

Dear Dr. Kendrick,

URGENT PATIENT SAFETY WARNING TO MAYO CLINIC’S DR.

Hooman Noorchashm

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Feb 20

Mayo Clinic’s Claim of “FDA-Approved” Robotic Nipple-Sparing Mastectomy: False Advertising and…

Post-publication Addendum: Following publication of this article, the Mayo clinic revised its press release and eliminated its false claim…

Mayo Clinic’s Claim of “FDA-Approved” Robotic Nipple-Sparing Mastectomy: False Advertising and…

Hooman Noorchashm

Hooman Noorchashm

Hooman Noorchashm MD, PhD is a public health advocate and Research Professor of Law. His opinions on Medium.com are not necessarily those of his employers.

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