Digital Pathology
Digital pathology is an image-based information environment that is enabled by computer technology to allow for the management of information generated from a digital slide. It is enabled in part by virtual microscopy, which is the practice of converting glass slides into digital slides that can be viewed, managed, and analyzed on a computer monitor. With the advent of whole-slide imaging, the field of digital pathology has exploded and is currently regarded as one of the most promising avenues of diagnostic medicine to achieve even better, faster and cheaper diagnosis, prognosis and prediction of cancer and other important diseases.
Digital pathology also holds the promise of interconnecting pathologists around the globe in ways that will advance diagnostic accuracy and improve patient outcomes.
In pathology, trained pathologists look at tissue slides under a microscope. The tissue on those slides may be subjected to staining to highlight structures. When those slides are digitized, they then have the potential to be numerically analyzed using computer algorithms. Algorithms can be used to automate the manual counting of structures, or for classifying the condition of tissue such as is used in grading tumors.
This could reduce human error and improve accuracy of diagnoses. Digital slides are also, by nature, easier to share than physical slides. This increases potential for using data for education and consultations between two or more experts.
In April, the US Food and Drug Administration approved for marketing the Philips IntelliSite Pathology Solution (PIPS), the first whole slide imaging (WSI) system that allows for review and interpretation of digital surgical pathology slides prepared from biopsied tissue. It was the first time the FDA permitted the marketing of a WSI system for these purposes.
Thus the high cost of implementing this technology is slowing adoption of these systems by smaller private pathology groups. It is estimated that around 1,000 pathology labs worldwide own and use digital pathology systems on a regular basis.
Smaller organizations often believe they must engage in full adoption, which means digitizing all cases and every glass slide, then reading all the images on a monitor. Partial adoption is also possible, though, and new technology is expected to allow smaller pathology groups to go digital via a cloud-based pathologist workflow solution.
Fitting Pathology AI Firms into DP Market Puzzle
By Robert Michel | From the Volume XXXI, No. 12 – September 3, 2024 Issue
CEO SUMMARY: Today, the best-known developers of AI-based algorithms have been in business almost 10 years. During that time, there has been continuous improvement in the digital technologies used in digital scanning and digital image analysis. Despite these improvements, many pathology g…
Pioneering DP Companies Ended Up Being Acquired
By Robert Michel | From the Volume XXXI, No. 12 – September 3, 2024 Issue
CEO SUMMARY: One reason why the adoption of a full digital pathology solution has lagged behind expectations may be attributed to the fact that four of the pioneering companies did not survive as independent businesses. They were sold and not all the new owners continued investing and dev…
Why Many Pathologists Are Cautious about Digital Path
By Robert Michel | From the Volume XXXI, No. 12 – September 3, 2024 Issue
CEO SUMMARY: In many major academic centers and the nation’s largest regional pathology supergroups, use of whole slide images and digital pathology workflow are accepted and established. This is often because of benefits unsupported by a pure return on investment. The clinical gains ou…
Uncertainty in Market for Digital Path Products
By Robert Michel | From the Volume XXXI, No. 12 – September 3, 2024 Issue
CEO SUMMARY: These are uncertain times for many companies offering a range of digital pathology (DP) products to the nation’s pathologists. Sales lag behind projections that caused investors to pour money into numerous DP start-ups. One reason DP companies are not meeting sales goals is…
Clarapath Raises $36 Million for Automated Histology Solution
By Robert Michel | From the Volume XXXI, No. 12 – September 3, 2024 Issue
AS THE HISTOLOGY WORKFORCE STRUGGLES TO KEEP UP WITH RISING CASE DEMAND, Clarapath—a Hawt…
Digital Pathology Sales Put Gestalt on Inc. 5000’s Fast Growth List
By Scott Wallask | From the Volume XXXI, No. 12 – September 3, 2024 Issue
Digital pathology workflow provider Gestalt Diagnostics earned a place on the Inc. 5000 2023 list of the fastest growing p…
Digital Pathology Rollout Was ‘Big Bang’ at University of Louisville
By Scott Wallask | From the Volume XXXI, No. 12 – September 3, 2024 Issue
CEO SUMMARY: It took less than one year to achieve full implementation of whole slide imaging and digital pathology at the University of Louisville’s Department of Pathology. One decision was to s…
Digital Pathology Business Plan for Both Clinical and ROI Success
By Kristin Althea O’Connor | From the Volume XXXI, No. 12 – September 3, 2024 Issue
CEO SUMMARY: More pathology groups are ready to consider adopting whole-slide imaging and digital pathology. The decision to proceed should only be made after identifying the clinica…
CMS Ends Remote Reading of Pathology Glass Slides
By Scott Wallask | From the Volume XXXI, No. 12 – September 3, 2024 Issue
CEO SUMMARY: On the day the federal government ended the public health emergency for SARS-CoV-2, CMS issued an updated FAQ that ended the allowance for remote reviews of glass slides…
Fujifilm Buys Inspirata’s Digital Pathology Assets
By Robert Michel | From the Volume XXXI, No. 12 – September 3, 2024 Issue
CEO SUMMARY: Fujifilm’s acquisition of the digital pathology technologies and clients of Inspirata marks the departure of one early entrant into the digital pathology market. At the same time, executives from Fujifilm Healthcare Americas Corporation discuss why the company is incr…
CURRENT ISSUE
Volume XXXI, No. 16 – November 25, 2024
Two different federal lawsuits that challenge the authority of the federal Food and Drug Administration (FDA) to regulate laboratory developed tests (LDTs) will be combined. Plaintiffs and the government in both cases agreed to move forward on this basis.
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