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 ...
16 August 2021 - Amulet is the first and only minimally invasive treatment option to offer immediate closure of the left ...
12 August 2021 - FDA breakthrough designation granted to CytoSorbents' DrugSorb-ATR for removal of apixaban and rivaroxaban to reduce the risk ...
11 August 2021 - Approach based on acceptance and commitment therapy and a foundational clinically validated digital program licensed from University ...
5 August 2021 - Breakthrough designation will advance the development of industry’s first predictive diagnostic device for conversion to Alzheimer’s disease, ...
3 August 2021 - Kestra Medical Technologies announced today that the company has received U.S. FDA premarket approval for the ASSURE ...
3 August 2021 - US law generally requires testing of high-risk medical devices prior to approval, as well as pre-market evaluation ...
3 August 2021 - VenoValve is a potential treatment for approximately 2.4 million U.S. patients that suffer from severe chronic venous ...
29 July 2021 - BiovitalsHF approved for expedited FDA review process as a first-in-class digital therapeutic for heart failure that augments ...
21 July 2021 - Evren Technologies announced today that its non-invasive Phoenix earbud device received Breakthrough Device Designation from the ...
20 July 2021 - NeuroMetrix today announced that its Quell device has received breakthrough designation from the U.S. FDA for treating ...
19 July 2021 - HFX for painful diabetic neuropathy now the only spinal cord stimulation system approved by FDA to treat ...
19 July 2021 - Investigational EVAS system designed for patients with complex abdominal aortic aneurysm. ...