What counts as a breakthrough? 8 insights on the FDA’s approach to medical devices.

21 April 2022 - The word breakthrough carries a kind of weight: it’s a dramatic step forward, a critical advance in ...

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Zambon receives U.S. FDA breakthrough therapy designation for CMS I-neb in patients with non-cystic fibrosis bronchiectasis

21 April 2022 - CMS I-neb is an investigational treatment being developed as a potential first-in-class inhaled therapy for adult patients ...

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Merck announces U.S. FDA has granted breakthrough therapy designation for V116, the Company’s investigational 21 valent Pneumococcal conjugate vaccine, for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults

14 April 2022 - V116 designed to target serotypes that account for 85% of all invasive pneumococcal disease in individuals aged ...

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Acer Therapeutics’ Edsivo (celiprolol) granted FDA breakthrough therapy designation for vascular Ehlers-Danlos syndrome

4 April 2022 - Discussions on-going with FDA through special protocol assessment seeking agreement on planned pivotal Phase 3 DiSCOVER trial ...

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JW Therapeutics announces receipt of breakthrough therapy designation for Carteyva in mantle cell lymphoma in China

3 April 2022 - JW Therapeutics announced that the Center for Drug Evaluation of the National Medical Products Administration of China ...

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Cook Medical receives FDA breakthrough device designation for Zenith Thoraco+ endovascular system

31 March 2022 - Cook Medical’s Zenith Thoraco+ endovascular system (Thoraco+) has received breakthrough device Designation from the US FDA.  ...

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Pfizer granted FDA breakthrough therapy designation for respiratory syncytial virus vaccine candidate for the prevention of RSV in older adults

24 March 2022 - Pfizer today announced that its respiratory syncytial virus vaccine candidate, PF-06928316 or RSVpreF, received breakthrough therapy ...

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Insightec receives FDA IDE approval and breakthrough designation for NSCLC brain mets study

9 March 2022 - Designation and approvals mark key milestones in advancing Insightec blood brain barrier clinical roadmap using acoustic ...

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Merit Medical receives FDA breakthrough device designation for Embosphere microspheres for use in genicular artery embolisation for symptomatic knee osteoarthritis

7 March 2022 - Merit Medical Systems announced today that it has received breakthrough device designation from the U.S. FDA ...

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AltPep receives FDA breakthrough device designation for SOBA-AD, a simple blood test for the detection of Alzheimer’s disease

1 March 2022 - AltPep Corporation today announced the U.S. FDA granted the company breakthrough device designation for its SOBA-AD diagnostic ...

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Pfizer granted FDA breakthrough therapy designation for respiratory syncytial virus (RSV) vaccine candidate for the prevention of RSV in infants from birth up to six months of age by active immunisation of pregnant women

2 March 2022 - Pfizer today announced that its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, received breakthrough ...

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DynamiCare Health digital therapeutic receives FDA breakthrough device designation for treatment of smoking during pregnancy

23 February 2022 - If approved, DynamiCare’s DCH-001 would become the first prescription treatment for smoking cessation demonstrated to be safe ...

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Minimally invasive epilepsy treatment EASEE receives FDA breakthrough device designation

21 February 2022 - Precisis has received breakthrough device designation from the U.S. FDA for its EASEE brain stimulator. FDA’s ...

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Noninvasix receives FDA breakthrough device designation for non-invasive monitoring technology for sepsis

23 February 2022 - LIVOx is first monitoring device to non-invasively monitor sepsis by detecting a key indicator of septic ...

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FDA grants BI 1015550 breakthrough therapy designation for idiopathic pulmonary fibrosis

24 February 2022 - Designation is supported by Phase II efficacy and safety data that will be presented at ATS 2022. ...

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