JD Supra42m
FDA Layoffs, RFK Jr. at HHS, and What This Means for FDA-Regulated Companies
In recent weeks, the FDA has faced significant cuts, including the layoffs of probationary employees. These employees, many ...
Med Device Online9h
Mastering FDA Inspections: The Prep Work For Regulatory Success
In the medical device industry, FDA inspections are not a regulatory hurdle — they are a powerful tool for improving product ...
Revolutionary BiVACOR heart device moves to phase 2 of FDA trial
Like all mechanical hearts, BiVACOR currently acts as bridge for patients waiting for a human heart transplant, but its ...
medtechdive21h
Device industry scrambles as FDA job cuts cause delays
The cuts at the FDA’s device center could add “months, if not years” to the time it takes to bring products to market, an ...
JD Supra22h
Foreign Drug and Medical Device Manufacturers Under a Second Trump Administration: Increased Enforcement Scrutiny?
As discussions intensify about how the second Trump administration will reshape the regulatory landscape for U.S.-based life sciences firms, ...
Ezra Announces New FDA Clearance, Enhancing the Capabilities of Its Full-Body Scan Technology
Ezra, the healthcare AI startup revolutionizing early cancer detection through full-body MRI screening, today announced new 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its ...
US DOGE layoffs hit FDA staff reviewing Elon Musk’s Neuralink — What happens next?
A wave of federal job cuts initiated by the Department of Government Efficiency (DOGE) is impacting regulatory agencies ...
After fire kills 5-year-old boy, lawyer questions oversight of hyperbaric oxygen chambers
Annie Cooper couldn't free her 5-year-old son, Thomas, from a hyperbaric chamber as flames engulfed him last month. Her lawyer is looking for answers.
FDA Layoffs Impact Neuralink Trials and Medical Device Approvals
FDA Layoffs Shake Up Neuralink Trial Review Team. In a surprising move, the U.S. Food and Drug Administration (FDA) has laid off around 20 employees from its Office of Neurologica ...
President’s Day Weekend Firings At Government Agencies Within HHS
The Trump administration has begun purging thousands of employees at Department of Health and Human Service agencies, including the CDC, NIH, FDA and CMS.