Blog
RSS FeedPosted by Michael Wonder on 06 Feb 2025
Acrivon Therapeutics announces FDA has granted breakthrough device designation for ACR-368 OncoSignature assay for endometrial cancer
5 February 2025 - The ACR-368-tailored OncoSignature assay is being used to predict patients most likely to respond to ACR-368 in ...
Posted by Michael Wonder on 28 Jan 2025
Beckman Coulter receives FDA breakthrough device designation for Alzheimer's disease blood test
28 January 2025 - Beckman Coulter today announced the US FDA has granted breakthrough device designation to Beckman Coulter's Access p‑Tau217/β-Amyloid ...
Posted by Michael Wonder on 12 Sep 2024
FDA authorises first over the counter hearing aid software
12 September 2024 - Today, the US FDA authorised the first over the counter hearing aid software device, Hearing Aid Feature, ...
Posted by Michael Wonder on 26 Aug 2024
FDA clears first device to enable automated insulin dosing for individuals with type 2 diabetes
26 August 2024 - Agency supports broader access to innovative technology in diabetes management. ...
Posted by Michael Wonder on 08 Aug 2024
Medicare finalises reimbursement rule for breakthrough medical devices
7 August 2024 - The Centers for Medicare and Medicaid Services has finalised its rule easing reimbursement for medical device ...
Posted by Michael Wonder on 02 Aug 2024
Supernus resubmits NDA for SPN-830 apomorphine infusion device
1 August 2024 - Supernus Pharmaceuticals today announced it has resubmitted its new drug application for its apomorphine infusion device ...
Posted by Michael Wonder on 24 Jul 2024
Jeff Shuren, medical devices head at FDA, to leave the agency
23 July 2024 - Jeffrey Shuren, longtime chief regulator of medical devices at the FDA, announced to staff on Tuesday ...
Posted by Michael Wonder on 24 Jul 2024
Fixing the reimbursement and coverage divide between ‘breakthrough’ drugs and medical devices
23 July 2024 - The FDA designates as “breakthrough” technologies certain drugs and devices. This designation helps expedite the development and ...
Posted by Michael Wonder on 02 Jul 2024
FDA breakthrough therapy designation reduced late-stage drug development time
1 July 2024 - The FDA’s breakthrough therapy designation program was created to increase patient access to safe and effective therapies ...
Posted by Michael Wonder on 22 May 2024
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. ...
Posted by Michael Wonder on 19 Apr 2024
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, ...
Posted 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. ...