13 September 2022 - Potrero Medical announced today that the FDA granted breakthrough device designation for their AKI Predict machine learning ...
12 September 2022 - CurveBeam announced its medical diagnostic software, OssView, has received US FDA breakthrough device designation. ...
8 September 2022 - Breakthrough device designation recognizes Ceribell's point of care EEG as a first of its kind technology ...
7 September 2022 - Pfizer today announced that its investigational Group B Streptococcus vaccine candidate, GBS6 or PF-06760805, received breakthrough ...
26 August 2022 - Pharmaceutical stakeholders want the US FDA to be more flexible when revoking breakthrough therapy designations. ...
18 August 2022 - GyroStim, a multi-axis rotational chair, was invented by a Colorado father in his garage to aid ...
11 August 2022 - The Breakthrough Device Program is approaching terminal velocity. ...
3 August 2022 - Pegtibatinase granted breakthrough therapy designation by FDA. ...
22 July 2022 - Breakthrough therapy designation granted by FDA. ...
19 July 2022 - The Elecsys Amyloid Plasma Panel is intended to be used in conjunction with other clinical information in ...
18 July 2022 - Celcuity today announced that the U.S. FDA has granted gedatolisib breakthrough therapy designation for the treatment of ...
15 July 2022 - Neurophth Therapeutics today announced that the Center for Drug Evaluation of China National Medical Products Administration has ...
12 July 2022 - Designation allows for expedited review of transcatheter therapy designed to improve left ventricular structure and function ...
12 July 2022 - Each year, 2.8 million Americans will fail multiple depression therapies and be diagnosed with treatment-resistant depression. ...
11 July 2022 - Molecular diagnostic test for early detection of Lyme disease. ...