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U.S. Food and Drug Administration
Photos: Epiminder
With U.S. HQ in Dallas, Epiminder Gets FDA Authorization for Implantable Monitor for Epilepsy Patients
by Lance Murray | Apr 23, 2025
"As the first and only implantable continuous EEG monitor approved in the U.S., Minder can provide health care professionals and their patients with more accurate and timely diagnoses, enhanced therapeutic drug monitoring, and can better inform decisions on non-drug treatments like surgery," said Epiminder CEO Rohan Hoare.
by Lance Murray |
Feb 6, 2025
The honors to UTD's Michael Kilgard, PhD, Robert Rennaker, PhD, and Seth Hays, PhD, are the first time the award will go to scientists who have made significant strides in translational bioelectronic medicine research.
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by Lance Murray |
Nov 6, 2024
Caris said MI Cancer Seek will be used as a companion diagnostic to identify cancer patients who may benefit from treatment with targeted therapies.
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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.
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Samuel Barone, M.D., is a former Federal Drug Administration official and leader in the pharmaceutical space.
Nanoscope Therapeutics Strengthens Clinical, Regulatory Expertise with Appointment of Chief Medical Officer
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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by Lance Murray |
Mar 2, 2023
The FDA approval is not only a first for Reata's treatment of ultra-rare disease Friedreich's Ataxia. It's a first in the company's history, reports FiercePharma. On the news, Reata’s stock skyrocketed nearly 200% Wednesday, according to the Dallas Morning News, which cited an estimate that the drug will create a revenue stream in excess of $1 billion.
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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....
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Spectral MD's DeepView system looks beneath the skin's surface. [Photo: Spectral MD video]
Spectral MD Gets $27M to Advance Trials of AI-Powered Wound, Burn Care Device
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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