Pedro Martinez Clark, MD, FSCAI, interventional cardiologist, medical director of Amavita Heart and Vascular Health in Miami, set up community outreach efforts to screen patients in low-income neighborhoods.
The FDA’s current draft guidance on the approval process for AI devices does not specify the type of validation the agency recommends manufacturers use.
UPDATED: Private equity-backed groups such as Rad Partners have dominated IDR use, with "little evidence" rank-and-file radiologists are using the system, experts wrote in Health Affairs.
Despite amassing a wait list of 10,000 individuals, the company has confronted “significant barriers due to restrictions on private imaging services in Ontario.”
Beginning September 10, breast imaging facilities will be required to notify patients about the density of their breasts, among other regulatory changes.
The FDA ruled that this is a Class I recall due to the significant risks for patients. Customers are not required to return the devices, however. Inari Medical has provided updated warnings and recommendations that should be followed.
Deniss Zolotarjovs, 33, of Moscow, is allegedly a member of Karakurt, responsible for multiple U.S. hospital breaches, which included data being sold on the dark web.
CMS wants feedback after proposing a significant update to CCTA reimbursement payments. The American College of Cardiology, a longtime champion for improved cardiac CT payments, is now helping its members make their voices heard.