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RSS FeedPosted 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 13 Nov 2021
CMS repeals MCIT/R&N rule; will consider other coverage pathways to enhance access to innovative medical devices
12 November 2021 - Today, CMS is rescinding the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” (MCIT/R&N) ...
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 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 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 08 Oct 2021
Genentech’s anti-amyloid beta antibody gantenerumab granted FDA breakthrough therapy designation in Alzheimer’s disease
8 October 2021 - Gantenerumab is an investigational antibody in Phase 3 development for early Alzheimer's disease. ...
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 05 Oct 2021
Medicare reverses course on decision to universally cover breakthrough medical devices for 4 years
4 October 2021 - In January 2021, in the waning days of the Trump Administration, the CMS finalised a rule ...
Posted by Michael Wonder on 05 Oct 2021
Turning Point Therapeutics granted breakthrough therapy designation for repotrectinib treatment in patients with NTRK positive, TKI pretreated advanced solid tumours
4 October 2021 - Turning Point Therapeutics today announced the U.S. FDA granted a seventh regulatory designation to lead drug ...