OptraSCAN® Receives CE Mark Approval for In-Vitro Diagnostics Use
SAN JOSE, Calif.--(BUSINESS WIRE)-- OptraSCAN®, the leading end-to-end digital pathology solution provider, today announced that their whole-slide scanners have received CE Mark approval for European Standards applicable to “In-Vitro Diagnostics Directive (IVDD)” 98/79/EC for in-vitro diagnostics use. The CE Mark will allow OptraSCAN’s scanners to be sold in countries belonging to or affiliated to European Union (EU) that recognizes CE Mark.
OptraSCAN’s On-Demand desktop scanning systems are cloud-enabled and provide the ultimate flexibility for storing, archiving and managing digital images and metadata. These small footprint, low and high throughput scanners are fully-integrated, affordable and lightweight that can easily fit into small workspaces.
“The CE Mark specifically addresses the safety, quality and performance of In-Vitro Diagnostic Directives (IVDDs) (98/79/EC), and certifies that it has been created and manufactured to meet strict safety and health criteria for distribution in the European Union (EU). We are very pleased to receive this approval as it underlines our commitment in providing robust, high-quality solutions to meet the needs of diverse healthcare providers in the EU and affiliated countries,” said Abhi Gholap, Founder & CEO.
He further added, “This is a significant milestone for OptraSCAN to support pathologists from the European continent towards adopting Digital Pathology for their requirements.”
OptraSCAN® (www.optrascan.com), ISO 13485 certified, is an end-to-end digital pathology solution provider. OptraSCAN is focused on delivering fully integrated, affordable solutions that will maximize your return on investment and improve the performance of your pathology services. OptraSCAN® is a pioneer in the On-Demand Digital Pathology® System and is working to eliminate the barriers to “Go Digital” no matter the size of the pathology lab, the lab's throughput or global location.
OptraSCAN’s end-to-end solution provides effective acquisition of whole slide images, viewing, storing, sharing, reporting, analysis and management of digital slides and associated metadata, via On-Demand solution or outright purchase model. Follow us on LinkedIn and Twitter.