25 November 2023 - A new pathway proposed by CMS aims to expedite access to breakthrough devices while preserving Medicare’s independent ...
26 October 2023 - Paige announced today that the US FDA has granted breakthrough device designation for Paige Lymph Node, an ...
18 October 2023 - SeaStar Medical announces receipt of US FDA breakthrough device designation for its patented, first in class, ...
17 October 2023 - Rapid detection of modern blood thinners could reduce preventable complications in US hospitals. ...
9 October 2023 - Supernus Pharmaceuticals today announced it has resubmitted its new drug application for its apomorphine infusion device ...
15 September 2023 - Final guidance on the US FDA breakthrough device program includes new language noting that the program ...
12 September 2023 - Five years after promising to fix a flawed regulatory pathway widely used by medical device manufacturers, ...
20 July 2023 - T2 Biosystems announced today the US FDA has granted breakthrough device designation for the Company’s Candida auris ...
10 July 2023 - In a randomised controlled trial AspyreRx demonstrated clinically meaningful and statistically significant durable reductions in A1c. ...
4 July 2023 - Dexcom announced today that Health Canada has approved the next generation Dexcom G7 Continuous Glucose Monitoring System ...
21 June 2023 - Developed in collaboration with Mayo Clinic, with support from Pfizer, this ECG-AI algorithm aims to aid ...
10 May 2023 - An array of lawmakers called for a simpler reimbursement pathway for breakthrough devices at a Ways and ...
13 April 2023 - Designation represents progress for patients with suspected coronary microvascular dysfunction as the FDA recognises disease’s debilitating impacts ...
10 April 2023 - Reach Neuro's Avantis device delivers small electrical impulses to the spinal cord to help stroke survivors ...
31 March 2023 - The US FDA published a draft guidance outlining how sponsors of artificial intelligence and machine learning (AI/ML) ...