JD Supra46m
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 ...
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, ...
abcnews47h
MUSC leads trial to revolutionize cochlear implants
MUSC is leading the country in a clinical trial testing a new cochlear implant.Doctors at MUSC say they are the only site on ...
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 ...
MassDevice20h
First patient enrolled in IDE study of Conformal Medical’s next-gen LAAO device
Conformal Medical today announced on social media that the first U.S. site enrolled a patient in a trial of its next-gen ...
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 ...