Leica receives FDA approval for EnFocus OCT
Leica Microsystems’ subsidiary Bioptigen receives FDA’s 510(k) clearance for EnFocus
Leica Microsystems’ optical coherence tomography (OCT) division Bioptigen received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its EnFocus intrasurgical OCT system. EnFocus is an upgrade solution for new and existing ophthalmic surgical microscopes, extending their capability. EnFocus allows visualization of ocular tissue microstructure during ophthalmic surgery in high-resolution, thereby providing both anterior and posterior surgeons with subsurface insight while operating.
“The EnFocus intrasurgical OCT system provides excellent optical imaging performance for the surgeon employing a modular design which enables sharing between multiple microscopes in an operating theater,” said Markus Lusser, President of Leica Microsystems. “It cleverly adds an important capability to ophthalmic microscope platforms. The device is an innovative advancement in ophthalmic imaging that Leica customers called upon us to deliver, similar to the newly introduced Proveo ophthalmic microscope platform.”
“We are very excited to receive clearance to introduce the EnFocus intrasurgical OCT system, which provides ophthalmic surgeons with highly resolved, real-time, deep and wide-field images for use during ophthalmic surgery”, added Eric Buckland, CEO of Bioptigen. “This product introduction builds upon Bioptigen’s 10-year history of delivering advanced OCT imaging tools to the ophthalmic healthcare community”.
The EnFocus imaging systems, while mounted to surgical microscopes, are intended for use with patient populations from pediatric to adults. The systems acquire, process, and display depth-resolved images of ocular tissue using Spectral Domain Optical Coherence Tomography (SD-OCT), and are compatible with common retina fundus viewing systems.
More information about the EnFocus intrasurgical OCT:
More details on OCT technology on Science Lab:
More information on the acquisition of Bioptigen by Leica Microsystems:
The EnFocus intrasurgical OCT system allows upgrade of new and existing ophthalmic surgical microscopes.
About Leica Microsystems
Leica Microsystems develops and manufactures microscopes and scientific instruments for the analysis of microstructures and nanostructures. Ever since the company started as a family business in the nineteenth century, its instruments have been widely recognized for their optical precision and innovative technology. It is one of the market leaders in compound and stereo microscopy, digital microscopy, confocal laser scanning microscopy with related imaging systems, electron microscopy sample preparation, and surgical microscopes.
Leica Microsystems has seven major plants and product development sites around the world. The company is represented in over 100 countries, has sales and service organizations in 20 countries, and an international network of distribution partners. Its headquarters are located in Wetzlar, Germany.