GlobalData on MSN9h
Nearly a third of FDA medical device adverse event reports filed late
A new study found that 9.1% of medical device AEs were reported to the FDA 180 days later than required over a three-year ...
BioPharma Dive1d
Douglas Kelly, deputy science director at FDA’s device center, leaves agency
Kelly, who made several key hires at the CDRH and helped negotiate the last user fee agreement, announced his departure in a ...
In patient portals, people prefer AI
Duke patients in a new study prefer patient portal messages written using artificial intelligence — until they learn AI wrote ...
States eye mRNA vaccine limits for a hesitant public
Christopher Ridley, a spokesperson for Moderna, said the state legislative efforts are largely a product of ...
STAT2d
Pharmalittle: We’re reading about Lilly and Roche weight loss drugs, FDA and compounders, and more
Three U.S. senators are calling on Robert Kennedy Jr. to disclose what he and President Trump discussed with drugmakers ...
Healio3d
Green orthopedics: Spend our precious health care dollars wisely
Orthopedic surgery is a marvelous field because we can make meaningful improvements in the comfort and function of patients ...
The BMJ22h
Late adverse event reporting from medical device manufacturers to the US Food and Drug Administration: cross sectional study
Objective To describe the extent of late adverse event reporting by manufacturers to the US Food and Drug Administration’s (FDA) Manufacturer And User Facility Device Experience (MAUDE) database as ...
medtechdive2d
Medical Devices
Capstan Medical, a startup focused on robotic-assisted mitral and tricuspid valve replacement, recently completed its first implants in patients.