SeaStar Medical granted FDA breakthrough device designation for a novel immunomodulatory therapy for acute kidney injury patients

3 May 2022 - Designation helps enable accelerated regulatory review of up-coming pivotal clinical trial for treatment in adult patients with ...

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Limaca Medical receives FDA breakthrough device designation

2 May 2022 - Limaca's precision GI endoscopic biopsy device advances precision medicine. ...

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SpineX receives FDA breakthrough device designation for SCiP

2 May 2022 - SpineX’s proprietary non-surgical device SCiP offers new hope for children with cerebral palsy. ...

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Nocira becomes first company ever to announce breakthrough device designation by the FDA for acute treatment of migraine

27 April 2022 - Nocira's hand held device that uses gentle, controlled puffs of air in the ears for treating migraine ...

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T2 Biosystems announces submission for FDA breakthrough device designation for T2Biothreat Panel

27 April 2022 - T2 Biosystems announced today that it has submitted an application with the U.S. FDA for breakthrough device ...

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Enhertu granted breakthrough therapy designation in the US for patients with HER2 low metastatic breast cancer

27 April 2022 - Based on DESTINY-Breast04 results where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a significant improvement in both progression-free ...

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Quanterix granted breakthrough device designation from U.S. FDA for NfL test for multiple sclerosis

22 April 2022 - Blood based assay has the potential to serve the multiple sclerosis community in management of relapsing-remitting form ...

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Bridge to Life receives breakthrough device designation from the FDA

21 April 2022 - Bridge to Life advances their perfusion system development with the breakthrough device designation for the LifeCradle ...

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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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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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