Pediatric Indication Articles & Analysis
8 news found
“The recent FDA clearance of the EvoEndo® Single-Use Endoscopy System marks a significant milestone for our company and is a major step forward in making unsedated endoscopy a reality for pediatric and adult patients,” said Heather Underwood, Chief Executive Officer at EvoEndo. “Our Single-Use Endoscopy system is the first sterile single-use system to enable ...
ByEvoEndo
The FDA has already approved a 10-patient, phase 1/2 clinical trial for repair of the esophagus in adults. The FDA has indicated a willingness to consider expanding the current clinical trial to include pediatric subjects once the safety of the implant is shown in adults. ...
Those results demonstrated a greater than 93% reduction in severe disease. These pediatric data were the basis of Ocugen’s pediatric Emergency Use Authorization (EUA) submission in the United States for children 2-18 on November 5, 2021. ...
In addition, we are eager to deliver the proven clinical benefit of IMCIVREE to patients in China and plan to pursue local approvals rapidly in five initial indications, while supporting Rhythm’s ongoing clinical development efforts more ...
Xarelto is the only Factor Xa anticoagulant FDA approved for pediatric patients and offers a flexible weight-based dosing Xarelto is available in both oral tablet and liquid suspension formulations for use in appropriate children less than 18 years of age Convenient liquid formulation advances standard of care for children; alleviates administration challenges found with ...
ByBayer AG
NeuroSigma, Inc., a Los Angeles-based bioelectronics company that is commercializing trigeminal nerve stimulation (TNS) technology to treat neurological and neuropsychiatric disorders, announced today that the following patents have issued or received notices of allowance in Canada and Japan: Canadian patent no. 2776694 entitled Devices, Systems, and Methods for Treatment of Neuropsychiatric ...
"NeuroSigma's Monarch eTNS System was the first non-drug treatment for pediatric ADHD cleared by the FDA. Starting April 1st of this year, payers will be able to use these unique new HCPCS codes to establish coverage policies and payment decisions," said Ian Cook, M.D., Chief Medical Officer of NeuroSigma. ...
” competition presented by FDA-sponsored National Capital Consortium for Pediatric Device Innovation. The competition focused on innovations in COVID-19-related pediatric medical devices that will improve children’s health care, with 16 finalists competing in a virtual pitch event for a share of $250,000 in total grant awards. ...