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 ...

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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.  ...

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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 ...

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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 ...

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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.  ...

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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 ...

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The FDA’s ‘breakthrough’ medical devices are finally hitting the market in numbers

11 August 2022 - The Breakthrough Device Program is approaching terminal velocity.  ...

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Travere Therapeutics provides regulatory updates on its development programs

3 August 2022 - Pegtibatinase granted breakthrough therapy designation by FDA. ...

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Vertex advances VX-548 in acute and neuropathic pain

22 July 2022 - Breakthrough therapy designation granted by FDA. ...

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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 ...

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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 ...

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China CDE grants breakthrough therapy designation to Neurophth's NR082 in Leber's hereditary optic neuropathy

15 July 2022 - Neurophth Therapeutics today announced that the Center for Drug Evaluation of China National Medical Products Administration has ...

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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 ...

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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. ...

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T2 Biosystems receives FDA breakthrough device designation for the T2Lyme panel

11 July 2022 - Molecular diagnostic test for early detection of Lyme disease. ...

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