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Home » Topics » Clinical

Clinical
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Study finds AI may be as good as docs at interpreting medical images despite flawed data

Sep. 26, 2019
By Nuala Moran
LONDON – The first systematic review and meta-analysis of the accuracy of artificial intelligence in health care has concluded AI may be as good as clinicians in interpreting medical images, but it is hard to be sure because of the poor quality of published studies. Researchers at Birmingham University, U.K. considered 31,887 journal papers appearing between January 2012 and June 2019, of which 20,530 were screened. They found most were methodologically flawed.
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Corvia launches Interatrial Shunt Device trial using Physiq's biosensor

Sep. 25, 2019
By Annette Boyle
Corvia Medical Inc. is enrolling patients in a 100-site multinational study of its Interatrial Shunt Device that will measure traditional heart failure endpoints as well as biosensor data transmitted to the cloud for analysis by Napier, Ill.-based Physiq's artificial intelligence analytics. The trial will evaluate Tewksbury, Mass.-based Corvia's device in heart failure with preserved and mid-range ejection fraction.
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Product clinical data for Sept. 23, 2019

Sep. 24, 2019

FDA lays framework for engaging patients in device clinical trials

Sep. 24, 2019
By Meg Bryant
BOSTON – The FDA's Center for Device and Radiological Health (CDRH) released draft guidance on Monday aimed at encouraging the use of patient input in medical device clinical trials and helping sponsors understand how they can use patient engagement to improve the design and conduct of investigations.
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Tocagen shares trounced after phase III brain cancer trial results in 'clear miss'

Sep. 18, 2019
By Michael Fitzhugh
Shares of San Diego-based Tocagen Inc. (NASDAQ:TOCA) fell 77.7% to 93 cents on Sept. 12, and further since, after its two-part immunotherapy for people with recurrent brain cancer failed to surpass standard of care on overall survival (OS), the primary endpoint of the company's phase III Toca 5 trial. Secondary endpoints in the registrational study were also missed, showing no meaningful difference between study arms.
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Kahr aiming for I-O combo, testing DSP-107 plus Roche PD-L1 in lung cancer study

Sep. 18, 2019
By David Ho
HONG KONG – In one of the latest combination efforts against cancer, Kahr Medical Ltd. is teaming up with Switzerland's Basel-based Roche Holding AG to study the use of the former's lead program, DSP-10, in combination with the latter's PD-L1-blocking checkpoint inhibitor, Tecentriq (atezolizumab), in patients with advanced non-small-cell lung carcinoma refractory to checkpoint inhibitors.
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Ritter struggles as its lead candidate fails phase III trial in lactose intolerance

Sep. 16, 2019
By Lee Landenberger
Ritter Pharmaceuticals Inc. is reeling from the phase III failure of its lead candidate, RP-G28, designed for patients with lactose intolerance. RP-G28 failed to demonstrate statistical significance in its primary endpoint as the top-line data showed it had no or little difference on patients compared to placebo. The data also show RP-G28 missed its secondary endpoints, all of which casts a shadow on the company and its pipeline.
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FDA expands Nucala label to include younger children

Sep. 16, 2019
By Michael Fitzhugh
Glaxosmithkline plc has won FDA approval to market Nucala (mepolizumab) for use in children as young as 6 with severe eosinophilic asthma (EA). The therapy already had FDA approval as an add-on maintenance treatment for kids with the same condition ages 12 and older. Approval of the sBLA, submitted last November, catches the U.S. market up to the EU, where Nucala has been approved as an add-on treatment for children ages 6 to 17 since August 2018.
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Prosthetic leg restores sensations, eases patient phantom pain

Sep. 13, 2019
By Nuala Moran

Product clinical data for Sept. 12, 2019

Sep. 13, 2019
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