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RSS FeedPosted by Michael Wonder on 07 Mar 2023
FDA grants Lenire tinnitus treatment device de novo approval
7 March 2023 - FDA approval based on results of 112 patient pivotal TENT-A3 clinical trial supported by confirmatory real world ...
Posted by Michael Wonder on 06 Mar 2023
Sooma Medical receives FDA breakthrough device designation for its innovative at home depression treatment device
6 March 2023 - Sooma Medical has been granted breakthrough device designation by the US FDA for its portable, patient-administered ...
Posted by Michael Wonder on 05 Mar 2023
Medicine and medical device pricing and reimbursement in Netherlands
2 March 2023 - Since the Netherlands is a Member State of the European Union, it has implemented the European ...
Posted by Michael Wonder on 02 Mar 2023
Boomerang Medical earns FDA breakthrough device designation
1 March 2023 - Boomerang Medical is currently enrolling a clinical trial studying a bioelectronic device for people living with Crohn’s ...
Posted by Michael Wonder on 27 Feb 2023
EMA pilots scientific advice for certain high risk medical devices
27 February 2023 - The EMA has launched a pilot to give scientific advice on the intended clinical development strategy ...
Posted by Michael Wonder on 23 Feb 2023
ONWARD receives new FDA breakthrough device designations for bladder control, alleviation of spasticity and blood pressure regulation after spinal cord injury
23 February 2023 - The company has now been awarded a total of eight FDA breakthrough device designations for its innovative ...
Posted by Michael Wonder on 21 Feb 2023
PHARMAC signals first step towards funding continuous glucose monitors
21 February 2023 - PHARMAC will soon be seeking competitive commercial offers for the supply of funded continuous glucose monitors ...
Posted by Michael Wonder on 16 Feb 2023
Zephyrus Innovations announces US FDA approval for its Aeroject 3 mL safety syringe
16 February 2023 - Aeroject has a permanently attached needle system, which upon retraction, fully encases the needle, preventing needle reuse ...
Posted by Michael Wonder on 16 Feb 2023
Merit Medical receives FDA breakthrough device designation for the new SCOUT MD surgical guidance system
16 February 2023 - Next generation system helps improve surgical precision to enhance patient care in breast and other soft tissue ...
Posted by Michael Wonder on 09 Feb 2023
CoolHealth enters US market with TargetCool, a breakthrough FDA class II medical device offering unprecedented precise, rapid cooling for pain management and bruise minimisation
8 February 2023 - CoolHealth is entering the US market with a breakthrough FDA Class II medical device, TargetCool. ...
Posted by Michael Wonder on 07 Feb 2023
Payback and health technology assessment in Italy: a new governance for medical devices?
1 February 2023 - While waiting for a new governance to make the process of selecting and purchasing medical devices more ...
Posted by Michael Wonder on 06 Feb 2023
Respiri becomes first Australian company to receive US reimbursements
6 February 2023 - The medical device manufacturer can now have its patented wheezo device, used for remote patient monitoring programs, ...
Posted by Michael Wonder on 23 Jan 2023
RenalGuard Therapy receives FDA breakthrough device designation for prevention of cardiac surgery associated AKI
20 January 2023 - CardioRenal Systems announced today that the FDA granted breakthrough device designation for its RenalGuard Therapy device ...
Posted by Michael Wonder on 19 Jan 2023
Abbott receives FDA approval for Navitor, a next generation TAVI system designed to treat aortic stenosis
17 January 2023 - Abbott's new Navitor device features advancements to improve patient care, including reducing or eliminating risk of blood ...
Posted by Michael Wonder on 18 Jan 2023
Modernising the Prostheses List Committee process
17 January 2023 - The Australian Government will modernise the existing committee process for prostheses applications through the new Medical ...