Benjamin Zegarelli

FDA Continues To Intentionally Incorporate AI Into Medical Product Development With Its Establishment Of A New Internal Advisory Body

CMS Issues Final Notice On Program For Breakthrough Device Reimbursement But Industry Looks To Congress For More Inclusive Solution

FDA And CTTI Hold Joint Workshop On AI In Drug Development

Five Observations From FDA's Responses To Comments In The Final Rule On LDTs

Changing Legal Environment Adds Uncertainty To ACLA Lawsuit Against FDA Over LDT Rule

ACLA Sues FDA To Block New LDT Oversight

FDA's Final LDT Rule Is Here, And The Changes Show The Agency Is Serious And Actually Listening To Stakeholders

LDT Oversight Gets Long-Awaited FDA Final Rule

Navigating Health Tech: Regulations For AI/ML In Medical Devices And Software (Video)

FDA Warning Letter Is A Stark Reminder That If You Claim Your Product Is RUO, It Has To Be RUO