Cook Medical receives FDA breakthrough device designation for Zenith fenestrated+ endovascular graft

1 March 2021 - Cook Medical’s Zenith fenestrated+ endovascular graft product has received breakthrough device designation from the US FDA.  ...

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Anuncia receives FDA breakthrough device designation for ReFlow System Mini

2 March 2021 - Anuncia received U.S. FDA breakthrough device designation for its ReFlow System Mini intended for the treatment of ...

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Apollo Endosurgery Receives FDA breakthrough device designation for the Orbera intragastric balloon for treatment of patients with NASH

1 March 2021 - Apollo Endosurgery announced today that it has received a breakthrough device designation from the U.S. FDA for ...

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Exelixis announces breakthrough therapy designation granted to cabozantinib for the treatment of patients with previously treated radioactive iodine-refractory differentiated thyroid cancer

25 February 2021 - Exelixis expects to submit supplementary New Drug Application in 2021. ...

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Dascena announces FDA breakthrough device designation granted to machine learning diagnostic method

24 February 2021 - Algorithm for earlier detection of gastro-intestinal bleeding. ...

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Kura Oncology receives FDA breakthrough therapy designation for tipifarnib in head and neck squamous cell carcinoma

24 February 2021 - Kura Oncology today announced that its investigational drug, tipifarnib, has been granted breakthrough therapy designation by the ...

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Locate Bio’s Chondro3 granted FDA breakthrough device designation

24 February 2021 - The Company’s second FDA Breakthrough Device designation granted in 2021. ...

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Inovise receives breakthrough device designation for novel non-invasive system to remotely monitor risk of decompensation in heart failure patients

23 February 2021 - Inovise Medical today announced the U.S. FDA has granted breakthrough device designation for its Audicor heart failure ...

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The BCMA CAR-T co-developed by Innovent and IASO was granted breakthrough therapy designation by the NMPA for the treatment of relapsed/refractory multiple myeloma

22 February 2021 - Innovent Biologics today jointly announce that the Center for Drug Evaluation of China's National Medical Products Administration ...

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Immunocore’s tebentafusp granted breakthrough therapy designation for unresectable or metastatic uveal melanoma from FDA

19 February 2021 - Submission of a biologic license application to FDA planned for Q3 2021. ...

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BrainCool receives FDA breakthrough device designation for Cooral System for prevention of oral mucositis

11 February 2021 - Recent Medicare reimbursement ruling provides an additional boost in paving the way for elimination of one of ...

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BrainQ gets FDA breakthrough status for its device for reducing disability following stroke

11 February 2021 - The breakthrough device designation, which comes after new trial data, is expected to expedite the device's path ...

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Cerus Endovascular receives FDA breakthrough device designation for its Contour Neurovascular System

11 February 2021 -  Cerus Endovascular today announced that it has received breakthrough device designation from the U.S. FDA for ...

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U.S. FDA grants breakthrough device designation to Vascular Perfusion Solutions for its visionary VP.S Encore cardiac transport device

8 February 2021 - The U.S. Food and Drug Administration (FDA) has granted Vascular Perfusion Solutions, Inc. (VPS) a Breakthrough Device ...

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Novartis receives FDA breakthrough therapy designations for investigational STAMP inhibitor asciminib (ABL001) in chronic myeloid leukaemia

8 February 2021 - Designation in patients with chronic myeloid leukaemia (CML) resistant or intolerant to prior treatments based on positive ...

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