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RSS FeedPosted by Michael Wonder on 18 Oct 2023
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. ...
Posted by Michael Wonder on 16 Sep 2023
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 ...
Posted by Michael Wonder on 13 Sep 2023
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, ...
Posted by Michael Wonder on 20 Jul 2023
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 ...
Posted by Michael Wonder on 12 Jul 2023
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. ...
Posted by Michael Wonder on 06 Jul 2023
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 ...
Posted by Michael Wonder on 22 Jun 2023
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 ...
Posted by Michael Wonder on 11 May 2023
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 ...
Posted by Michael Wonder on 14 Apr 2023
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 ...
Posted by Michael Wonder on 12 Apr 2023
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 ...
Posted by Michael Wonder on 03 Apr 2023
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) ...
Posted by Michael Wonder on 02 Apr 2023
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 ...
Posted by Michael Wonder on 29 Mar 2023
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 ...
Posted by Michael Wonder on 29 Mar 2023
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 ...
Posted by Michael Wonder on 09 Mar 2023
Mallinckrodt announces reimbursement approval in Japan for the Celllex extracorporeal photopheresis system for the treatment of chronic graft versus host disease
9 March 2023 - Cellex ECP is now available for reimbursement in Japan for patients who are steroid-resistant or intolerant ...