FDA OKs Philips’ IntelliSite Pathology Solution 5.1

Philips has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its IntelliSite Pathology Solution 5.1.

The digital pathology solution includes whole-slide scanners, an image management system, and implementation/support systems to guide the switch from analog to digital pathology workflows. It integrates hardware, software, and storage, analysis, and enterprise-wide connectivity.

IntelliSite leverages cloud-based services for integration of third-party, artificial intelligence (AI)-driven diagnostic applications, according to Philips. The company also said combining IntelliSite and Ibex Medical Analytics’ AI software to detect prostate cancer demonstrated 27% efficiency gains that translated into a 37% productivity gain and “very high” accuracy levels for multiple tissue types.

The solution’s open-platform approach and secure data sharing can facilitate medical research, with potential to develop new diagnostic algorithms, disease biomarkers, and treatment options based on large-scale digital pathology data sets.

Philips was the first to market an FDA-approved digital pathology solution in 2017. The company has helped over 300 pathology labs implement digital pathology in their laboratories.

“Digital pathology is helping to revolutionize how we diagnose and potentially treat cancer. With the 510(k) approval we expand our ability to help pathology laboratories transform to fully digital workflows, saving time and easing the burden on pathologists and patients,” said Martijn Hartjes, Clinical Informatics Business Leader at Philips. “We are advancing the digital transformation in pathology and multi-disciplinary clinical collaboration between pathologists, radiologists, oncologists, and other healthcare professionals, empowering clinicians with the tools they need to deliver improved patient outcomes and care.”