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The firm anticipates soon receiving FDA clearance for future products, including an AI-based prostate cancer detection system that received CE marking in 2019.
Paige said that the regulatory clearance paves the way for the in vitro diagnostic use of FullFocus with additional IVD whole slide imaging scanners.
The exemptions were granted to the Philips IntelliSite Pathology Solution and Leica's Aperio ImageScope DX Viewer.
The group aims to validate the tool, called OncoWatch, in a study involving nine countries this year.
While legislation and lawsuits sought to blunt PAMA's impact, labs also employed new technologies and strategies to cope with anticipated price cuts.
Philips and Paige said that through their collaboration they aim to provide digital pathology technologies for routine clinical practice.
The FDA gave the nod to Shenzhen Bioeasy Biotechnology for two lateral flow immunoassays that provide preliminary results in detecting marijuana in urine.
With two FDA-cleared platforms available, the technology is drawing clinicians interested in reaping its near-term benefits while preparing for its future impact.
The center will initially use the system for prostate, and head and neck cancers and in the future will let LabCorp patients access Mount Sinai pathologists.
While the first task of the centers will be to digitize their workflows to improve efficiency, they also aim to eventually develop new AI-based analytical tools for diagnosing patients.