East Lansing-based GreenMark Biomedical Inc. is an entrepreneurial example of how "it takes a village."
The company, which got approval from the Food and Drug Administration in March for dentists to use its oral rinse made with starch nanoparticles to detect tooth decay much earlier than…
GreenMark Secures FDA Clearance for LumiCare™ Caries Detection Rinse
Enhanced Visualization of Dental Caries is the First Commercial Application of Startup Venture s Nanotechnology Platform
News provided by
Share this article
EAST LANSING, Mich. and ANN ARBOR, Mich., April 8, 2021 /PRNewswire/
GreenMark™ Biomedical Inc. announced that the company has secured regulatory clearance from the U.S. Food and Drug Administration ( FDA ) to market its LumiCare™ Caries Detection Rinse as a 510(k) Class II Medical Device. Gaining FDA clearance for our LumiCare™ device at this particular time is especially gratifying given the significant pandemic challenges of the last year. I need to acknowledge the efforts of the entire GreenMark team and our regulatory partners, stated Dr. Steven Bloembergen, Ph.D., GreenMark s founder, Chairman and CEO. GreenMark plans to commence sales of the product in the fall of this year.