Dive Brief:
- Omnyx, founded in 2008 by a GE Healthcare-University of Pittsburgh Medical Center (UPMC) partnership, may soon reach its goal in creating the first FDA-approved digital pathology system for clinical use.
- Although the company filed for FDA-approval in 2014, the system was classified as a Class III device, with the highest risk classification. However, the FDA recently changed its status to a Class II device with fewer regulatory requirements.
- Advantages of the digital system include a faster diagnosis, easier delivery of digital images, and the development of advanced image analysis tools providing more individual treatment plans.
Dive Insight:
Omnyx CEO Mamar Gelaye told the Pittsburgh Business Times the system enables digital images to be sent quickly to specialized pathologists for diagnoses. She also said the delay in developing the system was due to low-power cameras that lacked the sufficient image resolution required. However, the technology has improved and the company already has products clinically approved in several other countries, including Europe and the Middle East.
The FDA is expected to make a decision within a year or two.
The global digital pathology market is expected to grow to $492.8 million by 2020, according to a Transparency Market Research report.