28 September 2021 - Nonagen Bioscience today announced Oncuria, their non-invasive bladder cancer test capable of predicting response to therapy, has ...
28 September 2021 - Selux next generation phenotyping now qualifies for expedited FDA review process as single-platform technology for rapid antimicrobial ...
28 September 2021 - Novian Health has been granted breakthrough device designation from the U.S. FDA for its Novilase Interstitial Laser ...
14 September 2021 - Nyxoah today announced that the U.S. FDA has granted the Genio bilateral hypoglossal nerve stimulation system breakthrough ...
9 September 2021 - Novocure today announced the United States FDA has granted breakthrough designation to the NovoTTF-200T System, a Tumour ...
9 September 2021 - Designation is based on results from the EMPEROR-Preserved Phase 3 trial, which established Jardiance as the first ...
8 September 2021 - Clinical trials of Madorra therapy system show promising results for treatment of vulvovaginal atrophy. ...
1 September 2021 - Endosound announced today that its EndoSound Vision System received a Breakthrough Device Designation from the U.S. FDA. ...
30 August 2021 - FDA recognises potential of SOZO digital health platform to assist clinicians in measuring exact fluid volume of ...
25 August 2021 - FirstSight now qualifies for expedited FDA review process as a blood test for detection of advanced neoplasia ...
23 August 2021 - ImpediMed is pleased to announce SOZO has received FDA breakthrough device designation for a proposed indication ...
18 August 2021 - The United States FDA has granted breakthrough device designation to Abiomed’s Impella ECP expandable percutaneous heart ...
17 August 2021 - Helius Medical Technologies today announced that it has received breakthrough designation from the U.S. FDA for its ...
12 August 2021 - FDA breakthrough designation granted to CytoSorbents' DrugSorb-ATR for removal of apixaban and rivaroxaban to reduce the risk ...
12 August 2021 - First-line nasopharyngeal indication and second/third line indications to be concurrently submitted 3Q 2021 in the toripalimab ...