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RSS FeedPosted by Michael Wonder on 26 Nov 2021
Blackrock Neurotech's MoveAgain brain computer interface system receives breakthrough device designation from the FDA
16 November 2021 - Blackrock Neurotech today announces that the U.S. FDA has granted breakthrough device designation for its groundbreaking ...
Posted by Michael Wonder on 25 Nov 2021
A divisive ruling on devices — Genus Medical Technologies v. FDA
24 November 2021 - The FDA has long taken the legal position that regulated devices could also be categorised as drugs. ...
Posted by Michael Wonder on 24 Nov 2021
HAGAR GWave awarded FDA breakthrough device designation
23 November 2021 - Expediting development of GWave technology that may potentially improve the health and quality of life for millions ...
Posted by Michael Wonder on 22 Nov 2021
FDA grants breakthrough designation for early stage breast cancer detection blood test developed by Datar Cancer Genetics
19 November 2021 - TriNetra is a circulating tumour cell detection blood test which is able to identify early stage ...
Posted by Michael Wonder on 20 Nov 2021
FDA grants Theradaptive breakthrough medical device designation
19 November 2021 - Theradaptive announced that the U.S. FDA has granted breakthrough medical device designation to its Osteo-Adapt SP Spinal ...
Posted by Michael Wonder on 10 Nov 2021
Ellume's COVID-19 home test recall most serious, FDA says
10 November 2021 - The U.S. FDA classified the recall of Ellume's over-the-counter COVID-19 home test as Class 1, the ...
Posted by Michael Wonder on 08 Nov 2021
Man & Science announces U.S. FDA breakthrough device designation granted for the treatment of chronic cluster headache
8 November 2021 - Man & Science announced today that it has been granted a breakthrough device designation by the Center ...
Posted 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 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
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 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 ...