Blog
RSS FeedPosted by Michael Wonder on 19 Mar 2022
Medical devices savings ‘missed’
17 March 2022 - Private health insurers say consumers will miss out on big savings on their premiums because the ...
Posted by Michael Wonder on 17 Mar 2022
Agreement reached on funding reforms for medical devices
17 March 2022 - The Medical Technology Association of Australia has signed a joint four-year agreement with the Commonwealth Government ...
Posted by Michael Wonder on 17 Mar 2022
Reforms to deliver lower prices for medical devices and lower private health insurance premiums
17 March 2022 - The Australian Government’s plan to make private health insurance simpler and more affordable for all Australians is ...
Posted by Michael Wonder on 11 Mar 2022
Diabetes NZ to kick-start campaign for PHARMAC funding for glucose monitors
11 March 2022 - Diabetes NZ wants PHARMAC to fund next-generation blood sugar monitors for people with the debilitating disease. ...
Posted by Michael Wonder on 09 Mar 2022
Insightec receives FDA IDE approval and breakthrough designation for NSCLC brain mets study
9 March 2022 - Designation and approvals mark key milestones in advancing Insightec blood brain barrier clinical roadmap using acoustic ...
Posted by Michael Wonder on 08 Mar 2022
Saluda Medical receives FDA approval for the Evoke spinal cord stimulation system to treat chronic intractable pain
8 March 2022 - Evoke system deemed superior to open loop spinal cord stimulation in treating overall back and leg pain. ...
Posted by Michael Wonder on 07 Mar 2022
Merit Medical receives FDA breakthrough device designation for Embosphere microspheres for use in genicular artery embolisation for symptomatic knee osteoarthritis
7 March 2022 - Merit Medical Systems announced today that it has received breakthrough device designation from the U.S. FDA ...
Posted by Michael Wonder on 03 Mar 2022
AltPep receives FDA breakthrough device designation for SOBA-AD, a simple blood test for the detection of Alzheimer’s disease
1 March 2022 - AltPep Corporation today announced the U.S. FDA granted the company breakthrough device designation for its SOBA-AD diagnostic ...
Posted by Michael Wonder on 01 Mar 2022
Regulation on EMA’s extended mandate becomes applicable
1 March 2022 - The regulation reinforcing EMA’s role in crisis preparedness and management of medicinal products and medical devices becomes ...
Posted by Michael Wonder on 28 Feb 2022
Minimally invasive epilepsy treatment EASEE receives FDA breakthrough device designation
21 February 2022 - Precisis has received breakthrough device designation from the U.S. FDA for its EASEE brain stimulator. FDA’s ...
Posted by Michael Wonder on 25 Feb 2022
Noninvasix receives FDA breakthrough device designation for non-invasive monitoring technology for sepsis
23 February 2022 - LIVOx is first monitoring device to non-invasively monitor sepsis by detecting a key indicator of septic ...
Posted by Michael Wonder on 23 Feb 2022
FDA permits marketing of first condom specifically indicated for anal intercourse
23 February 2022 - Other FDA cleared condoms can continue to be used for contraception and to prevent sexually transmitted infections. ...
Posted by Michael Wonder on 23 Feb 2022
Medtronic receives FDA approval for InterStim X system, the next generation of the most personalised sacral nerve stimulation therapy for bladder and bowel control
22 December 2022 - New InterStim X system provides 10 to 15 years of battery life without the need to recharge. ...
Posted by Michael Wonder on 22 Feb 2022
NeuroSigma receives FDA breakthrough device designation for Monarch eTNS system
22 February 2022 - Monarch eTNS recognised as novel device for drug resistant epilepsy. ...
Posted by Michael Wonder on 16 Feb 2022
Bonalive Biomaterials granted FDA breakthrough device designation for a bone graft substitute that potentially protects against microbial colonisation
16 February 2022 - The Center for Devices and Radiological Health at the U.S. FDA has determined that Bonalive Orthopedics granules, ...