Blog
RSS FeedPosted 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18 September 2019 - Today, the Food and Drug Administration issued draft guidance titled “Safer Technologies Program for Medical Devices,” ...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Device for preventing and relieving pain of cluster headaches approved by NICE in draft guidance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 ...
Posted by Michael Wonder on 23 Jun 2019
Statement on agency’s efforts to increase transparency in medical device reporting
21 June 2019 - In the spirit of promoting public transparency, the U.S. Food and Drug Administration’s Center for Devices ...
Posted by Michael Wonder on 22 Jun 2019
Delayed patient access to innovative medical technologies in South Korea: a lead-time analysis of reimbursement coverage determinations
20 June 2019 - Timely access to innovative medical technologies driven by accelerated patient access pathways can substantially improve the health ...
Posted by Michael Wonder on 08 Jun 2019
FDA permits marketing of first medical device for relief of pain associated with irritable bowel syndrome in patients 11-18 years of age
7 June 2019 - The U.S. FDA today permitted marketing of the first medical device to aid in the reduction ...
Posted by Michael Wonder on 04 Jun 2019
Consultation on draft guideline on quality requirements for medical devices in combination products
3 June 2019 - EMA has released a draft guideline on the quality requirements for medical devices in human medicines ...
Posted by Michael Wonder on 23 May 2019
FDA permits marketing of first diagnostic test to aid in detecting prosthetic joint infections
23 May 2019 - Today, the U.S. FDA permitted marketing of the Synovasure Lateral Flow Test Kit as an aid for ...