Iveric Bio announces FDA has granted breakthrough therapy designation for avacincaptad pegol for geographic atrophy

17 November 2022 - Designation based on 12 month primary endpoint data from GATHER pivotal trials. ...

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AVITA Medical announces FDA breakthrough device designations for the Recell system

3 November 2022 - AVITA Medical announced today that the FDA granted the Recell system designations as a breakthrough device for ...

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Rhythm Pharmaceuticals announces setmelanotide granted breakthrough therapy designation for hypothalamic obesity by the US FDA

1 November 2022 - Rhythm Pharmaceuticals today announced that setmelanotide received breakthrough therapy designation from the US FDA for the treatment ...

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Pfizer’s elranatamab granted FDA breakthrough therapy designation for relapsed or refractory multiple myeloma

3 November 2022 - Breakthrough therapy designation based on updated data from Phase 2 MagnetisMM-3 study that showed an overall response ...

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CorVista Health receives breakthrough device designation for the CorVista system

25 October 2022 - CorVista Health announces that the US FDA has granted breakthrough device designation for the CorVista System as ...

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EndoStim receives FDA breakthrough device designation for the EndoStim system for the treatment of drug refractory GERD

25 October 2022 - EndoStim announced today that the US FDA granted breakthrough device designation for the Company’s EndoStim system. ...

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Akeso's ivonescimab granted breakthrough therapy designation by China NMPA for the treatment of advanced NSCLC

20 October 2022 - Akeso announced that the Center for Drug Evaluation of China NMPA has granted breakthrough therapy designation ...

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Sinaptica Therapeutics announces FDA breakthrough device designation for its novel non-invasive neurostimulation treatment for Alzheimer’s disease

19 October 2022 - Breakthrough designation is based on positive outcomes from a Phase 2 clinical trial in mild to ...

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Axoft brain implant technology is granted FDA breakthrough device designation

18 October 2022 - Axoft today launched and announced FDA breakthrough device designation for its brain-machine interface to better treat ...

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FDA will begin accepting breakthrough devices for TAP pilot in 2023

11 October 2022 - The US FDA will start accepting products into its total product lifecycle advisory program (TAP) pilot starting ...

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Desktop Health receives FDA clearance for SmileGuard resin for durable and comfortable orthodontic and dental appliances

6 October 2022 - Dentists and labs can use proprietary SmileGuard resin to 3D print bite splints, night guards, and mouth ...

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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, ...

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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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