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RSS FeedPosted by Michael Wonder on 30 Nov 2021
AMF Medical receives FDA breakthrough device designation for its Sigi insulin management system
30 November 2021 - Sigi is the only insulin patch pump for closed loop integration designed for use with standard, pre-filled ...
Posted by Michael Wonder on 26 Nov 2021
Blackrock Neurotech's MoveAgain brain computer interface system receives breakthrough device designation from the FDA
16 November 2021 - Blackrock Neurotech today announces that the U.S. FDA has granted breakthrough device designation for its groundbreaking ...
Posted by Michael Wonder on 25 Nov 2021
Preparing for health care’s new frontier: Committee releases major report on reforming the process for new medicines and health technology
25 November 2021 - A new parliamentary report ‘The New Frontier: Delivering better health for all Australians’ is recommending significant ...
Posted by Michael Wonder on 25 Nov 2021
MTAA welcomes new frontiers report
25 November 2021 - The Medical Technology Association of Australia wishes to thank Trent Zimmerman MP and Dr Mike Freelander MP ...
Posted by Michael Wonder on 25 Nov 2021
A divisive ruling on devices — Genus Medical Technologies v. FDA
24 November 2021 - The FDA has long taken the legal position that regulated devices could also be categorised as drugs. ...
Posted by Michael Wonder on 25 Nov 2021
MSAC publishes agenda for upcoming meeting
24 November 2021 - 10 agenda items for consideration at the 31 March - 1 April 2022 meeting. ...
Posted by Michael Wonder on 24 Nov 2021
HAGAR GWave awarded FDA breakthrough device designation
23 November 2021 - Expediting development of GWave technology that may potentially improve the health and quality of life for millions ...
Posted by Michael Wonder on 22 Nov 2021
FDA grants breakthrough designation for early stage breast cancer detection blood test developed by Datar Cancer Genetics
19 November 2021 - TriNetra is a circulating tumour cell detection blood test which is able to identify early stage ...
Posted by Michael Wonder on 20 Nov 2021
FDA grants Theradaptive breakthrough medical device designation
19 November 2021 - Theradaptive announced that the U.S. FDA has granted breakthrough medical device designation to its Osteo-Adapt SP Spinal ...
Posted by Michael Wonder on 15 Nov 2021
When insurers choose, patients lose - campaign launched to protect patient choice
15 November 2021 - A new public health campaign to protect Australians’ access to life-saving therapies and medical technologies has ...
Posted by Michael Wonder on 14 Nov 2021
Additional support for Australians with rare skin conditions
12 November 2021 - The Australian Government is providing additional support, reducing the out of pocket costs for hundreds of Australians ...
Posted by Michael Wonder on 13 Nov 2021
CMS repeals MCIT/R&N rule; will consider other coverage pathways to enhance access to innovative medical devices
12 November 2021 - Today, CMS is rescinding the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” (MCIT/R&N) ...
Posted by Michael Wonder on 10 Nov 2021
Ellume's COVID-19 home test recall most serious, FDA says
10 November 2021 - The U.S. FDA classified the recall of Ellume's over-the-counter COVID-19 home test as Class 1, the ...
Posted by Michael Wonder on 09 Nov 2021
WHO warns of massive syringe shortfall in 2022
10 November 2021 - There could be a shortage of up to two billion syringes in 2022 with billions more than ...
Posted by Michael Wonder on 08 Nov 2021
Man & Science announces U.S. FDA breakthrough device designation granted for the treatment of chronic cluster headache
8 November 2021 - Man & Science announced today that it has been granted a breakthrough device designation by the Center ...