Blog
RSS FeedPosted by Michael Wonder on 05 Nov 2021
FDA awards breakthrough device designation to the ReWalk ReBoot Soft Exo-Suit
4 November 2021 - Soft exoskeleton device for stroke survivors will be for use at home and in the community ...
Posted by Michael Wonder on 04 Nov 2021
TecTraum’s pro2cool receives FDA designation as a breakthrough device for the treatment of concussions
3 November 2021 - TecTraum today announced that the U.S. FDA has designated its flagship technology, pro2cool, as a breakthrough ...
Posted by Michael Wonder on 02 Nov 2021
FDA grants breakthrough status for Alzheimer's treatment
2 November 2021 - Renew Bioscience announced it has received breakthrough device designation status from the U.S. FDA for the ...
Posted by Michael Wonder on 28 Oct 2021
Breakthrough Ortek-ECD technology enables dentists to detect cavities often not seen by X-rays
26 October 2021 - Ortek announced today the widespread availability of its ECD device, which provides dental professionals a new diagnostic ...
Posted by Michael Wonder on 28 Oct 2021
MY01 continuous compartmental pressure monitor granted breakthrough device designation from the FDA
28 October 2021 - MY01 receives their first-ever breakthrough device designation by the FDA in October, joining a select list of ...
Posted by Michael Wonder on 21 Oct 2021
FDA grants breakthrough device designation for Biological Dynamics’ early stage pancreatic cancer detection test
20 October 2021 - Designation provides expedited regulatory review of Exo-PDAC, a liquid biopsy assay, built on the company’s Verita ...
Posted by Michael Wonder on 20 Oct 2021
Coverage with evidence development schemes for medical devices in Europe: characteristics and challenges
20 October 2021 - Medical devices are potentially good candidates for coverage with evidence development schemes, as clinical data at market ...
Posted by Michael Wonder on 20 Oct 2021
FDA pre-submission for saliva based glucose test to replace invasive finger prick
19 October 2021 - The iQ Group Global, on behalf of its subsidiary, Life Science Biosensor Diagnostics, is pleased to announce ...
Posted by Michael Wonder on 20 Oct 2021
CMS grants transitional pass through payment for Carlsmed's aprevo personalized interbody device
19 October 2021 - -Carlsmed announced today that CMS has granted aprevo a transitional pass through payment as part of the ...
Posted by Michael Wonder on 12 Oct 2021
Quanterix granted breakthrough device designation from U.S. FDA for blood based pTau 181 assay for Alzheimer’s disease
11 October 2021 - Quanterix Corporation announced today that its Simoa phospho-Tau 181 (pTau-181) blood test has been granted breakthrough ...
Posted by Michael Wonder on 09 Oct 2021
Alpha Tau receives FDA's breakthrough device designation for the treatment of recurrent glioblastoma multiforme
8 October 2021 - Alpha Tau Medical is pleased to announce that it has received breakthrough device designation for Alpha ...
Posted by Michael Wonder on 07 Oct 2021
FDA issues final order and guidance on surgical staplers and staples for internal use
7 October 2021 - Today, the U.S. FDA announced several actions related to surgical stapler and staple regulation and safety. ...
Posted by Michael Wonder on 06 Oct 2021
Amber Implants VCFix spinal system receives US FDA breakthrough designation
5 October 2021 - Set to vastly improve treatment of vertebral fractures. ...
Posted by Michael Wonder on 02 Oct 2021
Medical device reforms to lower health fund premiums
2 October 2021 - Health fund premium rises will be 20% lower next year, and the reason for the savings ...
Posted by Michael Wonder on 30 Sep 2021
FDA clears first major imaging device advancement for computed tomography in nearly a decade
30 September 2021 - The device uses the emerging CT technology of photon counting detectors which can measure each individual X-ray ...