FDA to modernize, finalize 510(k) clearance pathway for medical devices

The FDA has announced plans to modernize and finalize its 510(k) clearance pathway as part of a continuing effort to advance the review of safety and effectiveness of medical devices, according to a recent statement from FDA Commissioner Scott Gottlieb, MD, and Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health (CDRH).

Cardiac CT analysis facilitates safe valve implantation in patients with CHD

CT analysis prior to percutaneous pulmonary valve implantation (PPVI) in patients with congenital heart disease (CHD) could help physicians detect which individuals are at the greatest risk for coronary artery compression (CC) during the procedure, according to research published ahead of print in the European Journal of Radiology.