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FDA
Highlander Health Co-Founders Amy Abernethy, M.D., Ph.D., and Brad Hirsch, M.D. [Photo: Business Wire]
Pegasus Park Speaker Series To Offer ‘Insights From the Frontlines of Health Policy’ by Former FDA Leaders
by David Seeley | Apr 10, 2025
Moderated by Highlander Health Co-Founder Brad Hirsch, next Wednesday's free public event will feature two former FDA commissioners and a former FDA acting chief information officer. The focus: "how the FDA has evolved across four presidential administrations."
by David Seeley |
Dec 13, 2023
Based in Vancouver with a North Texas office in Frisco, Alpha Cognition said its novel oral tablet ALPHA-1062 is designed for the treatment of people with mild to moderate Alzheimer's disease. The company was honored at the recent BioNTX iC3 Summit as one of eight "Rising Stars."
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by David Seeley |
Dec 11, 2023
On Friday, the first CRISPR-based gene-editing therapy to win FDA approval was announced. CASGEVY holds "the potential of a functional cure" for sickle cell disease—and Medical City Children’s is one of only nine hospitals in the U.S. in its initial network of authorized treatment centers.
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by Quincy Preston |
Jul 18, 2023
Parker Health's cloud Health Management System is the first in the U.S. to build on the Fast Healthcare Interoperability Resources—or FHIR—standard to create an interoperable, affordable, and compliant cloud-based platform. The Parker Suite aims to unify patient-centric data, biometrics, diagnostic tools, patient outcomes, care delivery, practitioner engagement, and pharmaceuticals for the healthcare ecosystem.
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[Image: Myvector/iStockphoto]
Dallas’ MedCognetics Gets FDA Clearance for Its AI-Enabled Breast Cancer Screening Software
by David Seeley | Dec 20, 2022
The early-stage startup's QmTRIAGE software platform uses AI and machine learning to detect early breast cancers with a "high rate" of accuracy, MedCognetics says. The company has worked with UT Southwestern and UT Dallas to ensure its AI improves outcomes for "all ethnicities," at a time when racial disparities in AI have become a growing concern.
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by Kevin Cummings |
Oct 18, 2022
Dallas-based Nanoscope Therapeutics is accelerating the development of therapies that could restore sight in patients with the help of a publicly traded firm. The retinal degenerative diseases-focused biotech company announced a new gene therapy manufacturing partnership with contract research organization Charles River Laboratories International.
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by Dallas Innovates | Staff Report |
Oct 17, 2022
Today is the first day that over-the-counter hearing aids can be sold without a prescription. It’s a moment that Fort Worth-based Lucid Hearing has been eyeing for years.
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by Kevin Cummings |
Aug 9, 2022
“Opioids are diabolical, because they actually change the structure and function of your brain; they change the way your reward system works,” said Daniel Powell, CEO at Spark Biomedical.
Meet Powell and six other startup leaders.
Meet Powell and six other startup leaders.
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Illustration: paitoonpati/iStock
Follow the Money: Jacobs Lands Nearly $4B NASA Contract; Dallas’ ReCode Therapeutics Adds $120M to Series B Raise, and More
by Kevin Cummings | Jul 11, 2022
Plus, Enhabit Home Health Hits the NYSE, Irving Web3 Investor Raising Two New Funds, TPG leads $750M raise in clean energy firm; Coppell-based Neurolens raises $2.7M; Fort Worth's Jet Health raises $1M; Frisco edtech startup Meritize lands funding; Honeywell acquires Fort Worth nitrile glove maker Rhino Health USA; and more North Texas-related deals.
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by Kevin Cummings |
May 12, 2022
AyuVis, an immunotherapy startup, is set to get a $1.8 million Small Business Innovation Research grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The funding will support the pre-clinical research of its drug candidate to treat the second-leading cause of death in premature babies.
Founder Suchismita Acharya calls the timing "perfect."
Founder Suchismita Acharya calls the timing "perfect."
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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 David Seeley |
Aug 16, 2021
Stelfonta received FDA approval last November to treat dogs with non-metastatic, skin-based mast cell tumors (MCTs)—the most common malignant skin tumor in dogs. The injection is now available at vet clinics across the U.S., with an 88% "satisfactory experience" rate to date.
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![Illustration of the Orthofix FIREBIRD SI Fusion System with NANOVATE technology [PHOTO: Business Wire]](https://s24806.pcdn.co/wp-content/uploads/2020/10/Orthofix-970-businesswire-940x436.jpg)
Illustration of the Orthofix FIREBIRD SI Fusion System with NANOVATE technology [PHOTO: Orthofix]
No Bones About It: Orthofix Gets FDA Clearance for 3D-Printed Bone Screw featuring Nanotechnology
by Quincy Preston | Oct 7, 2020
The Lewisville-based company's new fusion system is designed to compress and stabilize the sacroiliac joint. Its high-tech features make it the first of its kind specifically designed for SI joint solutions.
Other recent news includes a $10 million partnership with a Swiss medtech firm and a new division president.
Other recent news includes a $10 million partnership with a Swiss medtech firm and a new division president.
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by Quincy Preston |
Jul 28, 2020
One of just two de novo applications in Texas last year, the withdrawal is a casualty of “the uncertainty caused by the COVID-19 pandemic.” But founders of the proposed locally owned community bank are looking at options to refile in the near future.
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by Lance Murray |
Mar 20, 2020
Check out our weekly roundup on research and development activities by North Texas organizations to stay up-to-date on the important work.
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by Blair Welch |
Apr 30, 2019
MycoDART, which was named one of Health Wildcatter's six startup healthcare accelerators, has a new test that may have cracked the code on Candida auris, a type of yeast that can cause severe sickness in hospitalized patients.
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