Roche granted FDA breakthrough device designation for blood test measuring Lp(a) – a key marker for hereditary cardiovascular risk

22 May 2024 - The test has been developed in collaboration with Amgen. ...

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Medicare official says breakthrough device reimbursement rule coming in early summer

19 April 2024 - A federal rule aiming to make reimbursement for breakthrough devices easier is slated for early summer, ...

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Coverage for emerging technologies - bridging regulatory approval and patient access

25 November 2023 - A new pathway proposed by CMS aims to expedite access to breakthrough devices while preserving Medicare’s independent ...

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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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Dexcom G7 receives Health Canada approval: next generation continuous glucose monitoring system with unmatched accuracy coming to Canadians

4 July 2023 - Dexcom announced today that Health Canada has approved the next generation Dexcom G7 Continuous Glucose Monitoring System ...

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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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Lawmakers press CMS to release new breakthrough device coverage rule

10 May 2023 - An array of lawmakers called for a simpler reimbursement pathway for breakthrough devices at a Ways and ...

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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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