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U.S. Food and Drug Administration
Articulate Lab's Josh Rabinowitz presenting at Techstars Demo Day in Fort Worth in December 2022. [Photo: Techstars]
Dallas’ Articulate Labs Tapped by Medical Device Innovation Consortium for Advanced Tech Initiative
by Lance Murray | Aug 12, 2024
MDIC is piloting the AMCH program, with support from the U.S. Food and Drug Administration, to help encourage the medical device industry to adopt advanced technology not just during device production but across the total product life cycle.
by Lance Murray |
Oct 26, 2023
Revolution—which is based in Little Rock with corporate offices in Flower Mound and a manufacturing facility in Mesquite—says the introduction of clear food grade LLDPE PCR "will boost innovations in recycled packaging."
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by Lance Murray |
Sep 22, 2023
Samuel Barone, M.D., is a former Federal Drug Administration official and leader in the pharmaceutical space.
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by David Seeley |
Jun 29, 2023
Reata cleared the final FDA hurdle to get its rare-disease drug Skylarys on the market, the company announced Tuesday. The drug is now available to U.S. patients who've been diagnosed with Friedreich’s ataxia—a genetic disorder that can cause progressive damage to the nervous system. The announcement marks Reata’s first drug approval since the company was founded in 2002, according to the Dallas Morning News.
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Massoud Motamed of Nanoscope Therapeutics via LinkedIn
Nanoscope Therapeutics Names New Vice President of Quality
by Lance Murray | Jan 11, 2023
Nanoscope Therapeutics Inc., a Dallas-based clinical-stage biotechnology company developing gene therapies for retinal degenerative diseases, has appointed Massoud Motamed, Ph.D., as vice president of quality.
Motamed brings nearly a decade of CGMP quality and compliance experience, including extensive experience in manufacturing and regulatory review of gene therapy products.
“Massoud’s experience leading quality and compliance in CGMP manufacturing for gene therapies will be valuable as we progress in our chemistry, manufacturing, and controls (CMC) capabilities....
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by Kevin Cummings |
Apr 18, 2022
Frisco-based InspectIR received the FDA emergency use authorization on Friday for its breathalyzer test, which tests for organic compounds associated with COVID-19 in a person's breath. According to a study, the tests are more effective than the rapid antigen tests available for free from the U.S. government.
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by Lance Murray |
Jul 24, 2019
Spectral's device uses real-time data and artificial intelligence to help look beneath the skin's surface and assess wound and burn damage, which can help doctors improve treatments and outcomes — as well as be a tool in the response to mass burn casualties in a national emergency.
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by Lance Murray |
May 3, 2019
You'll also find out about how the FDA has granted Breakthrough Device status to a new Caris Life Sciences cancer test in this roundup of research and development activity in North Texas.
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