Blog
RSS FeedPosted by Michael Wonder on 25 Nov 2023
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 ...
Posted by Michael Wonder on 26 Oct 2023
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 ...
Posted by Michael Wonder on 19 Oct 2023
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, ...
Posted 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 13 Oct 2023
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 ...
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) ...