Proscia 510(k) adds muscle to Siemens Healthineers' Syngo Carbon pathology module

In another sign of the momentum of digital pathology in 2024, Proscia has expanded its Concentriq AP-Dx offerings into the U.S. following U.S. Food and Drug Administration 510(k) approval in February.

The approval complements Proscia's pathology module integration into Siemens Healthineers' Syngo Carbon digital workspace.

Adding the pathology module means that hospital and health system leaders interested in centralizing clinical and imaging data from different departments can now draw from pathology data and whole-slide imaging on the enterprise imaging and reporting network, Proscia CEO David West explained for LabPulse.

David West.David West.

For pathologists, the integration enables access to pathology departments to a range of software tools through Proscia's FDA-approved Concentriq AP-Dx software for digital pathology workflows, including primary diagnosis.

"Concentriq AP-Dx is designed for helping clinical settings of all sizes, from individual reference laboratories to the largest hospital systems, to drive confidence and efficiency gains," West said.

The FDA's approval followed a multisite clinical study at PathGroup, the South Bend Medical Foundation, and Spectrum Healthcare Partners, according to Proscia, that demonstrated diagnoses made on Concentriq AP-Dx were found to be noninferior to traditional glass-slide reads.

In the U.S., the class II Concentriq AP-Dx software-only device is cleared for clinical use with the Hamamatsu NanoZoomer S360MD slide scanner and the JVC JD-C240BN01A monitor. The pathology module adds to others on the Syngo Carbon workspace that include radiology and cardiology.

"Our view is that especially within hospital systems, the vision for integrated diagnostics is going to be of increasing relevance, where you have these very specialized and then subspecialized disciplines within radiology and pathology, but they're all playing some role in the patient's journey," West told LabPulse.

"Pathology digitization is a way to elevate pathology into that care paradigm, into that integrated diagnostic paradigm in a way that didn't exist before," West added. Further, pathology digitization can become an effective hospital networking tool.

Syngo Carbon acts as a hub from which clinicians can launch advanced visualization tools, such as through syngo.via for radiology, and other tools through the digital marketplace, according to Siemens Healthineers.

Svenja Lippok, head of digital pathology at Siemens Healthineers, explained to how Syngo Carbon's offerings are used to guide pathologists and their hospital administrative and technical teams toward digital conversion.

Svenja Lippok.Svenja Lippok.

"Pathology is going through a digital revolution, which means that workflows automatically will change a lot in the coming years. Our engagement with customers starts with understanding their workflows and their pain points," Lippok said. 

"We usually group teams with pathology expertise, technical specialists, and product experts to make sure we understand where they want to go but also what the goal can be and how we can work on getting there," Lippok said. "Building on Concentriq AP-Dx, our Syngo Carbon Enterprise Access allows pathologists to distribute their results across the hospital."

Syngo Carbon is a digital enterprise reading and reporting solution that provides one archive. Enterprise Access shows patient information from all modalities involved. If a pathologist, for example, wants to see a computed tomography or radiology report, the report can be accessed via Syngo Carbon. 

Some sites begin with implementation in multiple departments, or they can opt for a single department with the potential to grow, Lippok said. 

Pathology implementation may begin with one use case.

"Maybe you first want to look into digitization of the pathology department, for example, with breast cancer diagnosis," Lippok said. 

"When a pathologist gets tissue samples, usually data like a medical image has already been generated, and the assumption is that there is a tumor," Lippok said.

"Pathologists would like to see how the tumor looks, its shape and position. This is extremely relevant for their analysis. We can provide them access to this information, basically through a radiology viewer that they can use to also see these images linked to the report for this patient," Lippok added 

Pathologists with no digital pathology experience are guided as to what the digitization process can look like, according to Lippok.

"But maybe they also want to, in the end, leverage the full potential [of digitization]. We want to be the partner for the pathologist, to go on this journey with them and connect them with other disciplines," she said 

Most hospitals have some digital pathology scanners, but it's mostly for low-throughput research use cases or special stain quantification, West added.

"Getting people off the microscope and onto image-based workflows can come with a lot of discomfort, but I think that blueprint has already been written and hospitals are tapping into that. Primary diagnosis across the entire routine reviews, we're seeing labs totally rewiring their operation," West said.

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