Blog
RSS FeedPosted by Michael Wonder on 04 May 2022
Mirvie receives FDA breakthrough device designation for first test designed to indicate risk of preeclampsia months before symptoms occur
3 May 2022 - Breakthrough has the potential to address a leading cause of maternal mortality that impacts millions of ...
Posted by Michael Wonder on 04 May 2022
SeaStar Medical granted FDA breakthrough device designation for a novel immunomodulatory therapy for acute kidney injury patients
3 May 2022 - Designation helps enable accelerated regulatory review of up-coming pivotal clinical trial for treatment in adult patients with ...
Posted by Michael Wonder on 03 May 2022
Limaca Medical receives FDA breakthrough device designation
2 May 2022 - Limaca's precision GI endoscopic biopsy device advances precision medicine. ...
Posted by Michael Wonder on 02 May 2022
SpineX receives FDA breakthrough device designation for SCiP
2 May 2022 - SpineX’s proprietary non-surgical device SCiP offers new hope for children with cerebral palsy. ...
Posted by Michael Wonder on 28 Apr 2022
Nocira becomes first company ever to announce breakthrough device designation by the FDA for acute treatment of migraine
27 April 2022 - Nocira's hand held device that uses gentle, controlled puffs of air in the ears for treating migraine ...
Posted by Michael Wonder on 27 Apr 2022
T2 Biosystems announces submission for FDA breakthrough device designation for T2Biothreat Panel
27 April 2022 - T2 Biosystems announced today that it has submitted an application with the U.S. FDA for breakthrough device ...
Posted by Michael Wonder on 23 Apr 2022
Quanterix granted breakthrough device designation from U.S. FDA for NfL test for multiple sclerosis
22 April 2022 - Blood based assay has the potential to serve the multiple sclerosis community in management of relapsing-remitting form ...
Posted by Michael Wonder on 21 Apr 2022
Bridge to Life receives breakthrough device designation from the FDA
21 April 2022 - Bridge to Life advances their perfusion system development with the breakthrough device designation for the LifeCradle ...
Posted by Michael Wonder on 21 Apr 2022
What counts as a breakthrough? 8 insights on the FDA’s approach to medical devices.
21 April 2022 - The word breakthrough carries a kind of weight: it’s a dramatic step forward, a critical advance in ...
Posted by Michael Wonder on 20 Apr 2022
New drug application resubmission update
20 April 2022 - Polarean Imaging announces that further to the RNS issued on 31 March 2022, the Company can confirm ...
Posted by Michael Wonder on 04 Apr 2022
Upper Hutt dad's plea to PHARMAC to cover family's $5,200 a year bill for 'life changing' diabetes devices
2 April 2022 - A Kiwi teacher is calling for public funding for "life changing" diabetes devices after being forced ...
Posted by Michael Wonder on 03 Apr 2022
Cook Medical receives FDA breakthrough device designation for Zenith Thoraco+ endovascular system
31 March 2022 - Cook Medical’s Zenith Thoraco+ endovascular system (Thoraco+) has received breakthrough device Designation from the US FDA. ...
Posted by Michael Wonder on 24 Mar 2022
Abbott's FreeStyle Libre is first and only CGM system to gain expanded reimbursement in Japan to include all people with diabetes who use insulin
24 March 2022 - Without expanded coverage, continuous glucose monitoring reimbursements are limited to segment of people with diabetes who require ...
Posted by Michael Wonder on 22 Mar 2022
Hope for quadriplegics as ‘miracle treatment’ gets green light from regulator
21 March 2022 - In a major step forward for treating victims of paralysis, Australian regenerative medicine company Orthocell has ...
Posted 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 ...