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RSS FeedPosted by Michael Wonder on 02 Mar 2021
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. ...
Posted by Michael Wonder on 02 Mar 2021
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 ...
Posted by Michael Wonder on 02 Mar 2021
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 ...
Posted by Michael Wonder on 25 Feb 2021
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. ...
Posted by Michael Wonder on 25 Feb 2021
Dascena announces FDA breakthrough device designation granted to machine learning diagnostic method
24 February 2021 - Algorithm for earlier detection of gastro-intestinal bleeding. ...
Posted by Michael Wonder on 25 Feb 2021
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 ...
Posted by Michael Wonder on 24 Feb 2021
Locate Bio’s Chondro3 granted FDA breakthrough device designation
24 February 2021 - The Company’s second FDA Breakthrough Device designation granted in 2021. ...
Posted by Michael Wonder on 24 Feb 2021
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 ...
Posted by Michael Wonder on 23 Feb 2021
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 ...
Posted by Michael Wonder on 20 Feb 2021
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. ...
Posted by Michael Wonder on 11 Feb 2021
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 ...
Posted by Michael Wonder on 11 Feb 2021
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 ...
Posted by Michael Wonder on 11 Feb 2021
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 ...
Posted by Michael Wonder on 09 Feb 2021
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 ...
Posted by Michael Wonder on 09 Feb 2021
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 ...