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…
InI3CGLOBAL BlogsbySEO Agency·Oct 23, 2024510k When to Submit: Comprehensive GuideIf you are a medical device manufacturer considering entering the U.S. market, and you want to market your product, you must understand how…
InI3CGLOBAL BlogsbySEO Agency·Oct 15, 2024How Long Does It Take to Get 510k ApprovalManufacturers of medical devices that wish to enter the U.S. market must follow the FDA’s 510k procedure. “How long does it take to get…
InI3CGLOBAL BlogsbySEO Agency·Sep 18, 2024FDA 510k Clearance vs Approval ServicesIt’s not always obvious if a given product needs FDA 510k Clearance and approval, even though the US medical device market entry process…
InI3CGLOBAL BlogsbySEO Agency·Sep 15, 2024A Brief Overview of FDA’s 513(g) Submission servicesAs far as regulations are concerned, there is no other sector that is as regulated as the medical devices sector in the world. New to these…
InI3CGLOBAL BlogsbySEO Agency·Sep 9, 2024510(k) Clearance vs Approval Services Key DifferencesIt’s not always obvious if a given product needs FDA approval or a 510(k) clearance, even though the US medical device market entry process…
