Hooman Noorchashm·Mar 28The 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…
Hooman Noorchashm·Dec 27, 2025Toward Consistent Patient Safety: Addressing Gaps in FDA Medical Device OversightThe promise of reforming America’s public health institutions lies in applying rigorous, evidence-based scrutiny to preventable harms —…
Hooman Noorchashm·Aug 16, 2025On Use of the New and Non-Standard 510(k) Sternotomy Closure Device, VariTrax, by U.S.On January 30, 2024 the United States Food and Drug Administration (FDA) provided a company named CircumFix Solutions, Inc. with a 510(k)…
InAI Simplified in Plain EnglishbyAarthi Anbalagan·Mar 2, 2025How AI Gets Medical Devices Approved Faster — From Idea to Hospital!Ever taken an X-ray or MRI in a hospital and wondered who makes those giant machines? And how do hospitals get them?
Hooman Noorchashm·Dec 2, 2024Medical Device Safety and The Promise of Robert F.President-elect Donald J. Trump’s embrace of Robert F. Kennedy Jr’s Make America Healthy Again (MAHA) directive is one of the most…
