US FDA grants Paige breakthrough device designation for cancer detection in breast lymph nodes

26 October 2023 - Paige announced today that the US FDA has granted breakthrough device designation for Paige Lymph Node, an ...

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FDA Grants SeaStar Medical’s selective cytopheretic device breakthrough device designation for hepatorenal syndrome

18 October 2023 - SeaStar Medical announces receipt of US FDA breakthrough device designation for its patented, first in class, ...

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FloBio receives FDA's breakthrough device designation for bleeding risk diagnostic test

17 October 2023 - Rapid detection of modern blood thinners could reduce preventable complications in US hospitals. ...

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Supernus resubmits NDA for SPN-830 apomorphine infusion device

9 October 2023 - Supernus Pharmaceuticals today announced it has resubmitted its new drug application for its apomorphine infusion device ...

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FDA’s final breakthrough devices guidance now includes technologies that address health disparities

15 September 2023 - Final guidance on the US FDA breakthrough device program includes new language noting that the program ...

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FDA proposes changes to key approval pathway for medical devices, five years after promising

12 September 2023 - Five years after promising to fix a flawed regulatory pathway widely used by medical device manufacturers, ...

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T2 Biosystems receives FDA breakthrough device designation for Candida auris diagnostic test

20 July 2023 - T2 Biosystems announced today the US FDA has granted breakthrough device designation for the Company’s Candida auris ...

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Better Therapeutics receives FDA authorisation for AspyreRx to treat adults with type 2 diabetes

10 July 2023 - In a randomised controlled trial AspyreRx demonstrated clinically meaningful and statistically significant durable reductions in A1c. ...

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Anumana receives US FDA breakthrough device designation for its cardiac amyloidosis algorithm

21 June 2023 - Developed in collaboration with Mayo Clinic, with support from Pfizer, this ECG-AI algorithm aims to aid ...

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Genetesis receives second FDA breakthrough device designation for non-invasive diagnosis of myocardial ischaemia using CardioFlux MCG

13 April 2023 - Designation represents progress for patients with suspected coronary microvascular dysfunction as the FDA recognises disease’s debilitating impacts ...

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Reach Neuro receives FDA breakthrough device designation for device to restore arm and hand movement to chronic stroke patients

10 April 2023 - Reach Neuro's Avantis device delivers small electrical impulses to the spinal cord to help stroke survivors ...

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FDA draft guidance allows AI/ML devices to evolve without requiring new submissions

31 March 2023 - The US FDA published a draft guidance outlining how sponsors of artificial intelligence and machine learning (AI/ML) ...

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Pixium Vision announces FDA breakthrough device designation for the Prima System in dry AMD

31 March 2023 - PRIMAvera European pivotal trial in dry AMD fully recruited and on track to report primary endpoints around ...

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FDA grants breakthrough device designation to Aural Analytics for speech analytics software to be used in treatment of ALS

29 March 2023 - Aural Analytics today announced that its Speech Vitals - ALS technology has been granted designation as ...

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Medical device companies now need to prove to FDA they’re protected against cyber attacks

29 March 2023 - Hidden in this year’s federal spending bill, among major changes to Medicare payments to doctors and ...

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