Eastman Kodak Co.
Eastman Kodak Co. has submitted the
final clinical trial data and test results necessary for FDA premarket approval
of its computed radiography (CR) system for mammography. The DirectView CR Mammography
feature will enable physicians to use the company’s computed radiography systems
for both high-resolution digital mammography and general radiography exams.
The FDA already has accepted the system’s
manufacturing information and nonclinical data, so the company intends to market
the product in the US next year after final FDA approvals are granted.