FDA

FDA May Enact CBD and delta-8 THC Regulatory Recommendations Within Months

WASHINGTON DC - Food and Drug Administration officials said they are taking steps to announce a plan for how to regulate cannabis-derived products like CBD and delta-8 THC in the coming months. This comes as the agency is also leading a review into marijuana’s scheduling status. Congressional Cannabis Caucus co-chairs Reps. Earl Blumenauer (D-OR), Dave Joyce (R-OH), 

By |2022-12-29T10:20:48-05:00December 29th, 2022|Marijuana Business, News|

Fifth Eye Wins FDA Approval For Patient Safety Software

ANN ARBOR—Fifth Eye, a medical software startup developing real-time clinical analytics,  announced that the U.S. Food and Drug Administration has provided clearance to market its second generation clinical decision support software, the AHI System, to hospitals in the United States. AHI, pronounced AH-hee, stands for Analytic for Hemodynamic Instability. Hemodynamic instability is a condition in which

By |2022-02-08T10:13:55-05:00February 7th, 2022|ESD|

Ann Arbor Medical Device Company And Partner Get FDA Approval For COVID Treatment In Hot Spots

ANN ARBOR—Terumo Cardiovascular, a cardiovascular surgery products provider, announced a collaboration with Monmouth Junction, N.J.-based CytoSorbents Corp., to sell the latter company’s product CytoSorb to hospitals in 10 COVID-19 hotspot states. The states are Alabama, Arizona, California, Georgia, Louisiana, Mississippi, New Mexico, Oregon, Texas, and Washington. The product is designed to treat cytokine storm, a

By |2020-08-29T12:44:30-04:00August 29th, 2020|Coronavirus, Life Sciences, Life Sciences/Biotech, Science|

FDA Reports on Purity of Commercially Available CBD Products

WASHINGTON DC - Fewer than half of the commercially available hemp/CBD products tested this year by the US Food and Drug Administration (FDA) contain percentages of cannabidiol that are consistent with the products’ labelling, according to data provided by the agency in a recently released report to Congress. According to the report, the FDA tested 147

By |2020-08-03T14:46:53-04:00August 3rd, 2020|Marijuana Business, News|

How Does The GVSU Applied Medical Device Institute Help Entrepreneurs Negotiate The FDA Approval Process?

ROYAL OAK - What does it take for a medical device to get approved by the Federal Drug Administration for commercialization? Brent Nowak, PhD, executive director of the Applied Medical Device Institute of Grand Valley State University, explains how the process works. Nowak is interviewed on this segment of M2 TechCast by Keith Brophy, state

By |2017-03-06T11:46:26-05:00March 6th, 2017|Life Sciences, M2 TechCast, Podcasts|