Blog
RSS FeedPosted by Michael Wonder on 20 Sep 2022
XVIVO granted breakthrough device designation from the FDA for the liver assist device
20 September 2022 - XVIVO Perfusion has been granted breakthrough device designation from the US FDA for their liver assist device, ...
Posted by Michael Wonder on 14 Sep 2022
Potrero Medical receives FDA breakthrough device designation for Accuryn AKI predict algorithm
13 September 2022 - Potrero Medical announced today that the FDA granted breakthrough device designation for their AKI Predict machine learning ...
Posted by Michael Wonder on 12 Sep 2022
FDA grants breakthrough device designation for CurveBeam AI's OssView bone fragility software
12 September 2022 - CurveBeam announced its medical diagnostic software, OssView, has received US FDA breakthrough device designation. ...
Posted by Michael Wonder on 08 Sep 2022
Ceribell receives FDA breakthrough device designation for delirium indication
8 September 2022 - Breakthrough device designation recognizes Ceribell's point of care EEG as a first of its kind technology ...
Posted by Michael Wonder on 07 Sep 2022
FDA grants breakthrough therapy designation to Pfizer’s Group B Streptococcus vaccine candidate to help prevent infection in infants via immunisation of pregnant women
7 September 2022 - Pfizer today announced that its investigational Group B Streptococcus vaccine candidate, GBS6 or PF-06760805, received breakthrough ...
Posted by Michael Wonder on 26 Aug 2022
Stakeholders ask FDA to be more flexible on rescinding breakthrough drug designations
26 August 2022 - Pharmaceutical stakeholders want the US FDA to be more flexible when revoking breakthrough therapy designations. ...
Posted by Michael Wonder on 20 Aug 2022
Father invents balance treatment device for daughter; makes history with FDA clearance AND breakthrough device designation
18 August 2022 - GyroStim, a multi-axis rotational chair, was invented by a Colorado father in his garage to aid ...
Posted by Michael Wonder on 11 Aug 2022
The FDA’s ‘breakthrough’ medical devices are finally hitting the market in numbers
11 August 2022 - The Breakthrough Device Program is approaching terminal velocity. ...
Posted by Michael Wonder on 04 Aug 2022
Travere Therapeutics provides regulatory updates on its development programs
3 August 2022 - Pegtibatinase granted breakthrough therapy designation by FDA. ...
Posted by Michael Wonder on 23 Jul 2022
Vertex advances VX-548 in acute and neuropathic pain
22 July 2022 - Breakthrough therapy designation granted by FDA. ...
Posted by Michael Wonder on 19 Jul 2022
Roche's Elecsys Amyloid Plasma Panel granted FDA breakthrough device designation to enable a timely diagnosis of Alzheimer’s disease
19 July 2022 - The Elecsys Amyloid Plasma Panel is intended to be used in conjunction with other clinical information in ...
Posted by Michael Wonder on 18 Jul 2022
Celcuity announces FDA breakthrough therapy designation for gedatolisib for treatment of HR positive, HER2 negative metastatic breast cancer
18 July 2022 - Celcuity today announced that the U.S. FDA has granted gedatolisib breakthrough therapy designation for the treatment of ...
Posted by Michael Wonder on 13 Jul 2022
Ancora Heart receives breakthrough device designation from FDA for the AccuCinch ventricular restoration system
12 July 2022 - Designation allows for expedited review of transcatheter therapy designed to improve left ventricular structure and function ...
Posted by Michael Wonder on 13 Jul 2022
Abbott receives FDA breakthrough device designation to explore use of deep brain stimulation to manage severe depression
12 July 2022 - Each year, 2.8 million Americans will fail multiple depression therapies and be diagnosed with treatment-resistant depression. ...
Posted by Michael Wonder on 11 Jul 2022
T2 Biosystems receives FDA breakthrough device designation for the T2Lyme panel
11 July 2022 - Molecular diagnostic test for early detection of Lyme disease. ...