Philips is submitting positive study results for its digital imaging system for cancer to the FDA. The data could help the company get expanded approvals for its device in the U.S.
The controlled, multicenter pivotal validation study pitted Philips’ digital whole slide imaging system against traditional microscope diagnoses. Researchers found that the study met its endpoint because the imaging device could provide a diagnosis as well as a microscope.
“Proving that digital reads are not inferior to optical reads creates a foundation for a FDA submission that, if cleared, would allow for the shift to a digital operation that, in turn, may reap the additional benefits of collaboration, workflow efficiency and the use of precise tools for measurement and counting,” Dr. Michael Feldman, a professor of pathology at the Hospital of the University of Pennsylvania and a leader on the study, said in a statement.
The study included 16 pathologists at four sites in the U.S. Researchers carried out 16,000 reads across 2,000 cases.
Philips’ device is already approved in the U.S. to help doctors diagnose a certain kind of breast ca
ncer. The latest data backs a bid by the company to get the system approved for additional indications through a de novo submission.
