PRESS RELEASE / PRESSEINFORMATION
December 14, 2015
Leica receives FDA approval for EnFocus OCT
Leica Microsystems’ subsidiary Bioptigen receives FDA’s 510(k) clearance for EnFocus
Morrisville, NC, USA. 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:
http://www.leica-microsystems.com/products_enfocus
More details on OCT technology on Science Lab:
http://www.leica-microsystems.com/sciencelab_topics_oct
More information on the acquisition of Bioptigen by Leica Microsystems:
http://www.leica-microsystems.com/company/press-portal/tab-content/press-details/article/leicamicrosystems-to-acquire-oct-company-bioptigen/News/detail/
Claudia Müller / Anja Schué· Tel. +49 6441 29-2630 / -2201· corporate.communications@leica-microsystems.com
Leica Microsystems GmbH · Ernst-Leitz-Straße 17–37 · D-35578 Wetzlar · www.leica-microsystems.com
PRESS RELEASE / PRESSEINFORMATION
Caption:
The EnFocus intrasurgical OCT system allows upgrade of new and existing ophthalmic surgical
microscopes.
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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.
Claudia Müller / Anja Schué· Tel. +49 6441 29-2630 / -2201· corporate.communications@leica-microsystems.com
Leica Microsystems GmbH · Ernst-Leitz-Straße 17–37 · D-35578 Wetzlar · www.leica-microsystems.com