Epredia has received 510(k) clearance from the US Food and Drug Administration (FDA) for the E1000 Dx, a digital pathology workflow solution for streamlining laboratory cancer diagnostics.
Available in Europe since 2024, E1000 Dx comprises an automated digital whole-slide imaging scanner, medical-grade viewer, and advanced image management and viewer software. The solution can capture high-resolution digital images of up to 1,500 cancer tissue samples per day.
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To further expedite pathology lab throughput in processing samples, the E1000 is equipped with algorithm-based sample detection that pinpoints the location of a sample on a tissue, and a dual slide batch feeder for processing two samples at once.
According to Epredia, the E1000 is the first FDA-cleared digital pathology solution with a quality control feature in which an advanced focal map rescan can automatically be triggered by the system to provide an opportunity for a pathologist to examine a scan.
Asserting that digital pathology represents the future of cancer diagnostics, Epredia chief strategy officer Balazs Liposits noted that laboratories’ adoption of digital pathology has historically tended to mean that they had to piece different hardware and software together, leading to potential challenges around interoperability.
“At Epredia, we provide precision equipment that covers the total workflow of the laboratory from accessioning to sign out,” said Liposits.
“We launched the E1000 Dx to meet the needs of laboratories for throughput and quality, while also maintaining interoperability to help facilities maximise their digital pathology investment and minimise time needed from healthcare professionals.”
PHC Holdings acquired Thermo Fisher Scientific’s anatomical pathology business in 2019 for around $1.14bn. Following the acquisition, the business was renamed to Epredia.
According to GlobalData analysis, the global medical imaging market, which includes digital pathology, is forecast to reach a valuation of around $83.4bn by 2033.
Editor’s note: This article has been updated to clarify that Epredia’s E1000 Dx has been available in Europe since 2024, not 2017.
