Blog
RSS FeedPosted by Michael Wonder on 14 Nov 2019
Health funds pressure Canberra over $700 million medical devices 'failure'
14 November 2019 - Australia's health insurers are putting pressure on the federal government to overhaul how much they pay ...
Posted by Michael Wonder on 13 Nov 2019
ICER seeks public input to guide selection of non-drug assessment topics for 2020
13 December 2019 - Suggestions for new topics and comments on initial list of potential topics are encouraged; input most helpful ...
Posted by Michael Wonder on 24 Oct 2019
Proposed new classification rule for medical devices that administer medicines or biologicals by inhalation
24 October 2019 - The TGA thanks respondents who provided a submission in response to the public consultation paper Proposed new ...
Posted by Michael Wonder on 23 Oct 2019
Private health insurers say cost of medical devices putting pressure on premiums
23 October 2019 - After the lowest annual increases in 18 years, relief appears to have been short-lived. ...
Posted by Michael Wonder on 23 Sep 2019
Statement on FDA efforts to encourage patient engagement in medical device clinical investigations
23 September 2019 - At the U.S. FDA we are committed to keeping patients, their families and caregivers at the center ...
Posted by Michael Wonder on 19 Sep 2019
FDA continues to take steps to fulfil its commitment to strengthen and modernise the 510(k) medical device program
19 September 2019 - The U.S. FDA today announced that, as a first step toward implementation of the recently established Safety ...
Posted by Michael Wonder on 18 Sep 2019
FDA continues steps to promote innovation in medical devices that help advance patient safety through the Safer Technologies Program
18 September 2019 - Today, the Food and Drug Administration issued draft guidance titled “Safer Technologies Program for Medical Devices,” ...
Posted by Michael Wonder on 10 Sep 2019
Greg Hunt's medical deals come back to bite him
11 September 2019 - Health minister Greg Hunt’s efforts to rein in growth in private health insurance premiums looks like ...
Posted by Michael Wonder on 05 Sep 2019
FDA provides transparency and clarity on the Humanitarian Device Exemption pathway, helping bring more life-saving medical devices to patients in need
5 September 2019 - Today, the U.S. FDA issued a final guidance, Humanitarian Device Exemption (HDE) Program, to provide updated ...
Posted by Michael Wonder on 26 Aug 2019
Aust stent costs five times higher than NZ
23 August 2019 -FactCheck Investigation: Do heart stents cost Australian private health funds five times more than they cost in ...
Posted by Michael Wonder on 26 Aug 2019
'Remove rugs from aged care' to reduce health insurance costs, report says
22 August 2019 - The medical devices industry is pushing back against further reforms to lower the cost of hip ...
Posted by Michael Wonder on 30 Jul 2019
Moving from substantial equivalence to substantial improvement for 510(k) ddevevices
29 July 2019 - Medical devices have been receiving more public attention and scrutiny in recent years because of safety problems. ...
Posted by Michael Wonder on 25 Jul 2019
Aptar’s nasal unidose device approved by US FDA for first needle-free rescue treatment for severe hypoglycaemia
25 July 2019 - AptarGroup today announced that its Unidose Powder System was recently approved by the U.S. FDA for an ...
Posted by Michael Wonder on 14 Jul 2019
How the FDA uses science to speed medical device innovation
11 July 2019 - The MDDT program streamlines the medical device development and review process. ...
Posted by Michael Wonder on 05 Jul 2019
Device for preventing and relieving pain of cluster headaches approved by NICE in draft guidance
5 July 2019 - A handheld device that delivers a small electric current has been recommended by NICE for the prevention ...