FDA clears Danaher ’ s Leica Microsystem ’ s FL560 cerebrovascular fluorescence microscope filter

Danaher‘s (NYSE:DHR) Leica Microsystems said yesterday it won FDA 510(k) clearance for its FL560 fluorescence microscope filter designed for visualizing cerebrovascular blood flow when used in conjunction with dye fluorescein. The filter is designed to be integrated into a M530 OH6 neurosurgical microscope to provide real-time, high-contrast visualization of cerebral anatomy in native color and fluorescent blood flow, the Germany-based company said. Leica said that the integration of the filter allows for a high-contrast image with clearly visible anatomy, with even the smallest vessels delineated. “Leica Microsystems has been a leader in advanced surgical visualization for decades. We have achieved a number of ‘1sts’ over the years including the first FDA 510(k) clearance of a microscope for intra-operative angiography and the first company offering a surgical microscope to integrate three types of fluorescence capabilities. I am proud that our team again was able to be the innovation leader by being the first company to achieve FDA clearance for cerebrovascular fluorescence imaging with fluorescein. This demonstrates our commitment to deliver clinically relevant and validated solutions to clinicians that allow them to make crucial surgical decisions and as a result improve patient outcomes,” prez Markus Lusser said in a prepared statement. Last September, Danaher said it would buy molecular diagnostics company Cepheid in a deal valued at $...
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Business/Financial News Imaging Neurological Regulatory/Compliance Danaher Corp. leicamicrosystems Source Type: news