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FDA
[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.
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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