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RSS FeedPosted by Michael Wonder on 14 Sep 2021
Nyxoah announces U.S. FDA breakthrough device designation granted for the Genio system for obstructive sleep apnea and complete concentric collapse
14 September 2021 - Nyxoah today announced that the U.S. FDA has granted the Genio bilateral hypoglossal nerve stimulation system breakthrough ...
Posted by Michael Wonder on 10 Sep 2021
FDA grants breakthrough device designation to the NovoTTF-200T system for advanced liver cancer
9 September 2021 - Novocure today announced the United States FDA has granted breakthrough designation to the NovoTTF-200T System, a Tumour ...
Posted by Michael Wonder on 09 Sep 2021
FDA grants Jardiance breakthrough therapy designation for heart failure with preserved ejection fraction
9 September 2021 - Designation is based on results from the EMPEROR-Preserved Phase 3 trial, which established Jardiance as the first ...
Posted by Michael Wonder on 08 Sep 2021
FDA grants Madorra breakthrough device designation status for treatment of moderate to severe vulvovaginal atrophy
8 September 2021 - Clinical trials of Madorra therapy system show promising results for treatment of vulvovaginal atrophy. ...
Posted by Michael Wonder on 01 Sep 2021
U.S. FDA grants breakthrough device designation for innovative EndoSound vision ultrasound system
1 September 2021 - Endosound announced today that its EndoSound Vision System received a Breakthrough Device Designation from the U.S. FDA. ...
Posted by Michael Wonder on 30 Aug 2021
FDA grants breakthrough device designation for ImpediMed's SOZO digital health platform for renal failure
30 August 2021 - FDA recognises potential of SOZO digital health platform to assist clinicians in measuring exact fluid volume of ...
Posted by Michael Wonder on 26 Aug 2021
CellMax Life earns FDA breakthrough device designation for colon cancer & pre-cancerous adenomas screening blood test
25 August 2021 - FirstSight now qualifies for expedited FDA review process as a blood test for detection of advanced neoplasia ...
Posted by Michael Wonder on 24 Aug 2021
FDA grants breakthrough device designation for renal failure
23 August 2021 - ImpediMed is pleased to announce SOZO has received FDA breakthrough device designation for a proposed indication ...
Posted by Michael Wonder on 18 Aug 2021
FDA grants breakthrough device designation to Impella ECP, the world’s smallest heart pump
18 August 2021 - The United States FDA has granted breakthrough device designation to Abiomed’s Impella ECP expandable percutaneous heart ...
Posted by Michael Wonder on 17 Aug 2021
Helius Medical Technologies announces FDA breakthrough device designation for the treatment of dynamic gait and balance deficits following a stroke
17 August 2021 - Helius Medical Technologies today announced that it has received breakthrough designation from the U.S. FDA for its ...
Posted by Michael Wonder on 12 Aug 2021
Second U.S. FDA breakthrough device designation granted to CytoSorbents' DrugSorb-ATR anti-thrombotic removal system adding the removal of market leading direct oral anti-coagulants during urgent cardiothoracic surgery
12 August 2021 - FDA breakthrough designation granted to CytoSorbents' DrugSorb-ATR for removal of apixaban and rivaroxaban to reduce the risk ...
Posted by Michael Wonder on 12 Aug 2021
Junshi Biosciences and Coherus announce U.S. FDA breakthrough therapy designation granted for toripalimab for first-line treatment of nasopharyngeal carcinoma
12 August 2021 - First-line nasopharyngeal indication and second/third line indications to be concurrently submitted 3Q 2021 in the toripalimab ...
Posted by Michael Wonder on 11 Aug 2021
Swing Therapeutics receives FDA breakthrough device designation for digital therapeutic for the management of fibromyalgia, launches real world study
11 August 2021 - Approach based on acceptance and commitment therapy and a foundational clinically validated digital program licensed from University ...
Posted by Michael Wonder on 06 Aug 2021
Altoida awarded FDA breakthrough designation for development of world’s first precision neurology device for prediction of Alzheimer's disease
5 August 2021 - Breakthrough designation will advance the development of industry’s first predictive diagnostic device for conversion to Alzheimer’s disease, ...
Posted by Michael Wonder on 05 Aug 2021
Eiger announces FDA breakthrough therapy designation for avexitide for treatment of congenital hyperinsulinism
5 August 2021 - All five orphan programs now have breakthrough therapy designation. ...