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RSS FeedPosted by Michael Wonder on 30 Nov 2022
Swiss National Council votes to accept FDA approved medical devices
29 November 2022 - On November 28, the Swiss Parliament National Council voted to adapt its national laws, allowing Switzerland to ...
Posted by Michael Wonder on 18 Nov 2022
Diabetic accuses PHARMAC of faulty analysis of glucose monitors
17 November 2022 - Insulin-dependent diabetics say PHARMAC's decision to delay funding a potentially life-saving device appears to be based ...
Posted by Michael Wonder on 15 Nov 2022
Government supporting Australians living with type 1 diabetes
13 November 2022 - The Albanese Government is changing the lives for the 130,000 Australians living with type 1 diabetes by ...
Posted by Michael Wonder on 04 Nov 2022
AVITA Medical announces FDA breakthrough device designations for the Recell system
3 November 2022 - AVITA Medical announced today that the FDA granted the Recell system designations as a breakthrough device for ...
Posted by Michael Wonder on 02 Nov 2022
New reimbursement approved by the Japanese Ministry of Health, Labor and Welfare for the Accuray CyberKnife system to treat trigeminal neuralgia, a condition often causing severe facial pain
26 October 2022 - Accuray Incorporated announced today that the Japanese MHLW has approved reimbursement for the CyberKnife system for the ...
Posted by Michael Wonder on 20 Oct 2022
Sinaptica Therapeutics announces FDA breakthrough device designation for its novel non-invasive neurostimulation treatment for Alzheimer’s disease
19 October 2022 - Breakthrough designation is based on positive outcomes from a Phase 2 clinical trial in mild to ...
Posted by Michael Wonder on 18 Oct 2022
Axoft brain implant technology is granted FDA breakthrough device designation
18 October 2022 - Axoft today launched and announced FDA breakthrough device designation for its brain-machine interface to better treat ...
Posted by Michael Wonder on 14 Oct 2022
Decision to list a range of medical devices supplied by Biotronik
12 October 2022 - PHARMAC is pleased to announce the approval of a listing agreement with Biotronik for the supply ...
Posted by Michael Wonder on 13 Oct 2022
Nevro announces FDA approval of HFX iQ spinal cord stimulation system to personalise the treatment of chronic pain
12 October 2022 - Next generation Senza HFX iQ is the first and only spinal cord stimulation system that uses ...
Posted by Michael Wonder on 12 Oct 2022
FDA will begin accepting breakthrough devices for TAP pilot in 2023
11 October 2022 - The US FDA will start accepting products into its total product lifecycle advisory program (TAP) pilot starting ...
Posted by Michael Wonder on 07 Oct 2022
Desktop Health receives FDA clearance for SmileGuard resin for durable and comfortable orthodontic and dental appliances
6 October 2022 - Dentists and labs can use proprietary SmileGuard resin to 3D print bite splints, night guards, and mouth ...
Posted by Michael Wonder on 29 Sep 2022
MHRA appoints first new UK approved body to certify medical devices since Brexit
29 September 2022 - DEKRA Certification UK Ltd has now joined the three current UK Approved Bodies. ...
Posted by Michael Wonder on 27 Sep 2022
NICE recommends NHS collects real world evidence on devices that monitor people with Parkinson’s disease
27 September 2022 - Five promising technologies that could help improve symptoms and quality of life for people with Parkinson’s disease ...
Posted by Michael Wonder on 20 Sep 2022
Stryker receives FDA clearance for OptaBlate bone tumour ablation system
20 September 2022 - Stryker's first bone tumour ablation system with patented microinfusion technology offers a reliable solution for people ...
Posted by Michael Wonder on 20 Sep 2022
XVIVO granted breakthrough device designation from the FDA for the liver assist device
20 September 2022 - XVIVO Perfusion has been granted breakthrough device designation from the US FDA for their liver assist device, ...