Mikroscan Receives Market Clearance Authorization in European Union
Mikroscan’s SL5-E and L5 products now marketed and sold throughout the European Union.
November 5, 2018 (Carlsbad, CA) – Mikroscan Technologies, innovators and manufacturers of live robotic microscopy and whole slide imaging systems, announces it has received market clearance authorization for models SL5-E and L5 so that these products may be marketed and sold throughout the European Union. The SL5-E and L5 bear the CE marketing, indicating that the products are designed and manufactured in accordance to the In Vitro Devices directive as well as all other applicable directives. Mikroscan’s business and quality systems have been reviewed and found in compliance with the latest standards for Risk Management (ISO 14971:2012) and Quality Management Systems (ISO 13485:2016). The Dual mode SL5-E offers both live robotic microscopy and digital pathology whole slide imaging solutions that are compact, ideal for space constrained locations and easily integrated into existing pathology environments. The lower cost L5, remotely controlled robotic microscope, shares the same small product footprint as the SL5-E and offers the greater direct control and flexibility of the traditional microscope. Both systems are available with optional anti-vibration platforms, ideal for mobile laboratory settings.
Martin Stuart Ph.D., Mikroscan’s President & CEO commented, “We are responding to increasing global need for access to pathology expertise. Our remotely controlled, real-time microscopic review and low volume digital pathology are ideal for time critical applications such as frozen sections and rapid onsite evaluation of adequacy. Mikroscan solutions are the perfect complement to existing digital pathology solutions targeting the needs of high throughput scanning facilities.”
Mikroscan is a privately held company headquartered in Carlsbad, California. Our vision is that every patient receives the right diagnosis from the right expert at the right time; regardless of wherein the world they live. To achieve this goal, our products are compact, rapidly deployed, easy to use, portable, and highly affordable. To learn more visit www.mikroscan.com
*The clinical use claims described in the information provided have not been cleared or approved by the U.S. FDA nor is the SL5-E available in the United States.