Blog
RSS FeedPosted by Michael Wonder on 13 Jul 2022
Ancora Heart receives breakthrough device designation from FDA for the AccuCinch ventricular restoration system
12 July 2022 - Designation allows for expedited review of transcatheter therapy designed to improve left ventricular structure and function ...
Posted by Michael Wonder on 13 Jul 2022
Abbott receives FDA breakthrough device designation to explore use of deep brain stimulation to manage severe depression
12 July 2022 - Each year, 2.8 million Americans will fail multiple depression therapies and be diagnosed with treatment-resistant depression. ...
Posted by Michael Wonder on 11 Jul 2022
PHARMAC ‘procrastinating’ over funding glucose monitors, Diabetes NZ says
12 July 2022 - PHARMAC should stop procrastinating on funding glucose monitors for people with diabetes after the Government agency ...
Posted by Michael Wonder on 11 Jul 2022
T2 Biosystems receives FDA breakthrough device designation for the T2Lyme panel
11 July 2022 - Molecular diagnostic test for early detection of Lyme disease. ...
Posted by Michael Wonder on 11 Jul 2022
US FDA grants Spectral Medical breakthrough device designation for Toraymyxin for the treatment of endotoxemic septic shock
11 July 2022 - Breakthrough designation expected to help accelerate regulatory review. ...
Posted by Michael Wonder on 07 Jul 2022
PHARMAC keeps medical devices role despite failing to curb costs
8 July 2022 - The government is persisting with a way of buying hugely expensive medical devices that has been proven ...
Posted by Michael Wonder on 03 Jul 2022
Albanese Government delivering life changing devices for Australians with type 1 diabetes
3 July 2022 - The Albanese Government is delivering on our election commitment to give all 130,000 Australians with type 1 ...
Posted by Michael Wonder on 22 Jun 2022
FDA grants breakthrough device designation to VR mental illness treatment
22 June 2022 - A British startup that uses virtual reality to help deliver cognitive behaviour therapy has been granted a ...
Posted by Michael Wonder on 16 Jun 2022
MHRA joins international partnerships to set global standards for medicines and medical devices regulation
16 June 2022 - These are the International Medical Device Regulatory Forum, the International Council for Harmonisation of Technical Requirements for ...
Posted by Michael Wonder on 15 Jun 2022
NICE’s early value assessment for medtech: panning for nuggets of innovation gold
15 June 2022 - The explosion in digital health products has left NHS commissioners wondering how they can possibly sift out ...
Posted by Michael Wonder on 14 Jun 2022
FDA should step in to help spur AI/ML standards
13 June 2022 - The US FDA should support the burgeoning integration of artificial intelligence and machine learning in medical ...
Posted by Michael Wonder on 26 May 2022
Revolutionary wearable ultrasound device gains FDA approval
26 May 2022 - ManaMed has been granted FDA approval on its latest orthopaedic recovery device, ManaSport. ...
Posted by Michael Wonder on 21 May 2022
Bonesupport receives market authorisation for Cerement G in the US
18 May 2022 - BoneSupport today announced that the company has received market authorisation from the U.S. FDA, for the ...
Posted by Michael Wonder on 19 May 2022
NeuroMetrix reports that Quell wearable neuromodulation device has received FDA de novo authorisation as first non-pharmacological treatment for fibromyalgia
19 May 2022 - NeuroMetrix today announced U.S. FDAde novo authorisation to market the Quell neuromodulation device as an ...
Posted by Michael Wonder on 18 May 2022
Exactech announces FDA breakthrough device designation for JointMedica’s Polymotion hip resurfacing system
17 May 2022 - Exactech announced that the U.S. FDA has granted a breakthrough device designation for JointMedica’s Polymotion hip ...